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Sample records for counterfeit antiretroviral drugs

  1. Problems Associated With Substandard And Counterfeit Drugs In ...

    African Journals Online (AJOL)

    Problems Associated With Substandard And Counterfeit Drugs In Developing Countries: A Review Article On Global Implications Of Counterfeit Drugs In The Era Of Anti-Retroviral (ARVS) Drugs In A Free Market Economy.

  2. Counterfeit drugs and medical devices in developing countries

    Directory of Open Access Journals (Sweden)

    Glass BD

    2014-03-01

    Full Text Available Beverley D GlassSchool of Pharmacy and Molecular Sciences, James Cook University, Townsville, QLD, AustraliaAbstract: The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an increase in this trade resulting from the growing size and sophistication of drug counterfeiters. In addition, due to both cost and lack of availability of medicines, consumers in developing countries are more likely to seek out these inexpensive options. The World Health Organization is mindful of the impact of counterfeit drugs on consumer confidence in health care systems, health professionals, the supply chain, and genuine suppliers of medicines and medical devices. Antibiotics, antituberculosis drugs, and antimalarial and antiretroviral drugs are frequently targeted, with reports of 60% of the anti-infective drugs in Asia and Africa containing active pharmaceutical ingredients outside their pharmacopoeial limits. This has obvious public health implications of increasing drug resistance and negating all the efforts that have already gone into the provision of medicines to treat these life threatening conditions in the developing world. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world. The complexity of the problem will also be highlighted in terms of the definition of counterfeit and substandard medicines, including gray pharmaceuticals. Although this issue presents as a global public health problem, outcomes in developing countries where counterfeit

  3. Substandard/counterfeit antimicrobial drugs.

    Science.gov (United States)

    Kelesidis, Theodoros; Falagas, Matthew E

    2015-04-01

    Substandard/counterfeit antimicrobial drugs are a growing global problem. The most common substandard/counterfeit antimicrobials include beta-lactams (among antibiotics) and chloroquine and artemisin derivatives (among antimalarials). The most common type of substandard/counterfeit antimicrobial drugs have a reduced amount of the active drug, and the majority of them are manufactured in Southeast Asia and Africa. Counterfeit antimicrobial drugs may cause increased mortality and morbidity and pose a danger to patients. Here we review the literature with regard to the issue of substandard/counterfeit antimicrobials and describe the prevalence of this problem, the different types of substandard/counterfeit antimicrobial drugs, and the consequences for the individuals and global public health. Local, national, and international initiatives are required to combat this very important public health issue. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  4. Problems associated with substandard and counterfeit drugs in developing countries: a review article on global implications of counterfeit drugs in the era of antiretroviral (ARVs) drugs in a free market economy.

    Science.gov (United States)

    Nsimba, Stephen E D

    2008-12-01

    To review the global implications associated with the use of substandard and or counterfeit drugs in developing and may be developed countries. The focus of this review is particularly on antiretroviral (ARVs), antimalarials and other drugs. Review of various literatures through Pub-Med, Medline, Google and Internet search to retrieve and download published materials was done by the author of this review paper. When patients receive a counterfeit medicines, they are subjected to multiple risks. They often suffer more than just an inconvenience; as they become victims of fraud medicines and are all put at risk of adverse effects from unprescribed medicines or substandard ingredients. Additionally, patients may lose confidence in health care professionals including their physician and pharmacist, and potentially modern medicine or the pharmaceutical industry in general. Counterfeit or substandard (poor quality) drugs pose threats to society; not only to the individual in terms of the health side effects experienced, but also to the public in terms of trade relations, economic implications, and the effects on global pandemics. It is vital for suppliers, providers, and patients to be aware of current trends in counterfeiting in order to best prepare for encounters with suspicious products. Furthermore, this is an issue that needs to be continually dealt with on national and international policy levels. Developing countries should try their level best to establish good laboratories for monitoring and checking quality of all pharmaceuticals manufactured locally and those imported or donated to these countries. The Ministries of Health and all stakeholders involved in this issue must ensure that all drugs meet the set or established international standards and national standards. Failure to do so will be to misuse the hard earned forex that is normally borrowed from banks for the procurement and distribution of drugs to its people. Indeed sub-standard medications do more

  5. The health and economic effects of counterfeit drugs.

    Science.gov (United States)

    Blackstone, Erwin A; Fuhr, Joseph P; Pociask, Steve

    2014-06-01

    Counterfeit drugs comprise an increasing percentage of the US drug market and even a larger percentage in less developed countries. Counterfeit drugs involve both lifesaving and lifestyle drugs. To review the health and economic consequences of counterfeit drugs on the US public and on the healthcare system as a whole. This comprehensive review of the literature encompassed a search of MEDLINE/PubMed, Google Scholar, and ProQuest using the keywords "counterfeit drugs," "counterfeit medicines," "fake drugs," and "fake medicines." A search of the various FiercePharma daily newsletter series on the healthcare market was also conducted. In addition, the US Food and Drug Administration and the World Health Organization websites were reviewed for additional information. The issue of counterfeit drugs has been growing in importance in the United States, with the supply of these counterfeit drugs coming from all over the world. Innovation is important to economic growth and US competitiveness in the global marketplace, and intellectual property protections provide the ability for society to prosper from innovation. Especially important in terms of innovation in healthcare are the pharmaceutical and biopharmaceutical industries. In addition to taking income from consumers and drug companies, counterfeit drugs also pose health hazards to patients, including death. The case of bevacizumab (Avastin) is presented as one recent example. Internet pharmacies, which are often the source of counterfeit drugs, often falsely portray themselves as Canadian, to enhance their consumer acceptance. Adding to the problems are drug shortages, which facilitate access for counterfeits. A long and convoluted supply chain also facilitates counterfeits. In addition, the wholesale market involving numerous firms is a convenient target for counterfeit drugs. Trafficking in counterfeits can be extremely profitable; detection of counterfeits is difficult, and the penalties are modest. Counterfeit

  6. Legislations combating counterfeit drugs in Hong Kong.

    Science.gov (United States)

    Lai, C W; Chan, W K

    2013-08-01

    To understand legislation combating counterfeit drugs in Hong Kong. This study consisted of two parts. In part I, counterfeit drugs–related ordinances and court cases were reviewed. In part II, indepth interviews of the stakeholders were described. Hong Kong. All Hong Kong ordinances were screened manually to identify those combating counterfeit drugs. Court cases were searched for each of the identified cases. Then, the relevant judgement justifications were analysed to identify sentencing issues. Indepth interviews with the stakeholders were conducted to understand their perceptions about such legislation. Trade Marks Ordinance, Patents Ordinance, Trade Descriptions Ordinance, and Pharmacy and Poisons Ordinance were current legislative items combating counterfeit drugs. Sentencing criteria depended on: intention to deceive, quantity of seized drugs, presence of expected therapeutic effect or toxic ingredients, previous criminal records, cooperativeness with Customs officers, honest confessions, pleas of guilty, types of drugs, and precautionary measures to prevent sale of counterfeit drugs. Stakeholders’ perceptions were explored with respect to legislation regarding the scale and significance of the counterfeit drug problem, penalties and deterrents, drug-specific legislation and authority, and inspections and enforcement. To plug the loopholes, a specific law with heavy penalties should be adopted. This could be supplemented by non-legal measures like education of judges, lawyers, and the public; publishing the names of offending pharmacies; and emphasising the role of pharmacists to the public.

  7. Near-infrared imaging spectroscopy for counterfeit drug detection

    Science.gov (United States)

    Arnold, Thomas; De Biasio, Martin; Leitner, Raimund

    2011-06-01

    Pharmaceutical counterfeiting is a significant issue in the healthcare community as well as for the pharmaceutical industry worldwide. The use of counterfeit medicines can result in treatment failure or even death. A rapid screening technique such as near infrared (NIR) spectroscopy could aid in the search for and identification of counterfeit drugs. This work presents a comparison of two laboratory NIR imaging systems and the chemometric analysis of the acquired spectroscopic image data. The first imaging system utilizes a NIR liquid crystal tuneable filter and is designed for the investigation of stationary objects. The second imaging system utilizes a NIR imaging spectrograph and is designed for the fast analysis of moving objects on a conveyor belt. Several drugs in form of tablets and capsules were analyzed. Spectral unmixing techniques were applied to the mixed reflectance spectra to identify constituent parts of the investigated drugs. The results show that NIR spectroscopic imaging can be used for contact-less detection and identification of a variety of counterfeit drugs.

  8. Identification of Counterfeit Drugs by Community Pharmacists in ...

    African Journals Online (AJOL)

    Purpose: The problem of fake and counterfeit drugs is real and constitutes a major threat to the health and safety of the Nigerian population. A descriptive study was carried out to assess the methods of identification of counterfeit drugs by community pharmacists in Lagos State. Methods: The research instrument was a ...

  9. Counterfeiting in performance- and image-enhancing drugs.

    Science.gov (United States)

    Graham, Michael R; Ryan, Paul; Baker, Julien S; Davies, Bruce; Thomas, Non-Eleri; Cooper, Stephen-Mark; Evans, Peter; Easmon, Sue; Walker, Christopher J; Cowan, David; Kicman, Andrew T

    2009-03-01

    The current drastic escalation in obesity may be contributing to the exponential rise in drugs used for image enhancement. Drugs such as anabolic-androgenic steroids (AAS) are perceived as a viable method of achieving a perfect physique. They are also the most widely abused drugs in sport. The Internet has encouraged the abuse of expensive drugs, particularly human growth hormone (hGH), resulting in increased importation for personal use. The substantial increase in this market has opened up avenues for counterfeiting, estimated as a multi-million pound business. The acute adverse effects from contaminated vials may result in a variety of pathologies including communicable diseases. In 2007, in the UK, a series of intramuscular abscesses, requiring surgical treatment, led us to study samples obtained from the underground market. The analysis of 38 parenteral samples and 19 oral samples of tablets was performed by a World Anti-Doping Agency (WADA) accredited laboratory, in an attempt to establish the extent of available counterfeit products. Fifty-three per cent (20) of the injectable AAS esters and 21% (4) of the oral tablets were counterfeit. Culture and sensitivity revealed the presence of skin commensal organisms, which may have contributed to the development of the abscesses. Users of AAS and hGH for sport, including bodybuilding, are currently risking their health because of counterfeit and poorly controlled products. Copyright 2009 John Wiley & Sons, Ltd.

  10. Fake and Counterfeit Drug: A review

    African Journals Online (AJOL)

    intent to deceptively represent its origin authenticity or effectiveness. A counterfeit drug ... version of medication. The business of fake drugs is a lucrative crime that is .... management of target or most vulnerable groups of patients with high risk ...

  11. Economic analysis of use of counterfeit drugs: health impairment risk of counterfeit phosphodiesterase type 5 inhibitor taken as an example.

    Science.gov (United States)

    Sugita, Minoru; Miyakawa, Michiko

    2010-07-01

    The size of the market for counterfeit drugs throughout the world is considerable. Many cases of health impairment due to counterfeits have been reported. The market share of counterfeits in drug markets in developed countries is smaller than that in developing countries. However, the size of the market for counterfeits of phosphodiesterase type 5 inhibitors (PDE5Is) used as anti-erectile-dysfunction drugs is not small. The purpose of the present study was to analyze the health impairment risk of taking the counterfeit PDE5Is and the convenience of obtaining the counterfeits in Japan, using an economic methodology in order to work out countermeasures for reducing the health impairment risk. Information was obtained by interviewing employees of pharmaceutical and chemical corporations in Japan. The size of the market for counterfeit PDE5Is in Japan was recently estimated to be about 2.5 times larger than that of genuine PDE5Is. The price of the counterfeits in their market is reported to be nearly equal to that of the genuine PDE5Is. An outbreak of severe hypoglycemia among users of counterfeit PDE5Is containing an antidiabetic drug in Singapore was reported in 2008, and seven patients remained comatose as a result of prolonged neuroglycopenia. Four of them subsequently died, so the health impairment risk due to counterfeit PDE5Is should not be ignored. In order to obtain a genuine PDE5I in Japan, a patient must be examined and have a prescription written at a medical institution, and buy it at a dispensing pharmacy. Focusing on the health impairment risk due to counterfeit PDE5Is and the convenience of obtaining the counterfeits in Japan, we analyzed the effects on the prices and quantities of PDE5Is in the market from demand and supply curves, using an economic methodology. From the analysis, it was shown that the health impairment risk due to the counterfeits is underestimated in the market in Japan. Physicians should warn their patients not to buy counterfeit

  12. Safeguarding against substandard/counterfeit drugs: mitigating a macroeconomic pandemic.

    Science.gov (United States)

    Wertheimer, Albert I; Norris, Jeremiah

    2009-03-01

    Counterfeiting and the sale of substandard pharmaceutical products can no longer be ignored. At 10% of global trade, counterfeiting is affecting many countries, causing serious downstream expenses and resource shortages. To describe the nature and impact of drug product counterfeiting and substandard product sale and to present strategies that may have value in ameliorating these phenomena. A literature review was conducted, supplemented by interviews of key leaders/experts in the field and the search of relevant web sites. All of the data were combined, integrated, and coordinated to present the complete picture of this problem. In addition to known corruption in some of the least developed countries, the trail through developed countries was detected. This report identifies means to detect faulty products and describes efforts toward resisting and ending these corrupt practices. Counterfeit drugs, if not stopped, can be responsible for a macroeconomic pandemic where major portions of some populations may be too ill to work and where the health sector resources are completely overwhelmed, as with the case of HIV/AIDS.

  13. An exploration of counterfeit medicine surveillance strategies guided by geospatial analysis: lessons learned from counterfeit Avastin detection in the US drug supply chain.

    Science.gov (United States)

    Cuomo, Raphael E; Mackey, Tim K

    2014-12-02

    To explore healthcare policy and system improvements that would more proactively respond to future penetration of counterfeit cancer medications in the USA drug supply chain using geospatial analysis. A statistical and geospatial analysis of areas that received notices from the Food and Drug Administration (FDA) about the possibility of counterfeit Avastin penetrating the US drug supply chain. Data from FDA warning notices were compared to data from 44 demographic variables available from the US Census Bureau via correlation, means testing and geospatial visualisation. Results were interpreted in light of existing literature in order to recommend improvements to surveillance of counterfeit medicines. This study analysed 791 distinct healthcare provider addresses that received FDA warning notices across 30,431 zip codes in the USA. Statistical outputs were Pearson's correlation coefficients and t values. Geospatial outputs were cartographic visualisations. These data were used to generate the overarching study outcome, which was a recommendation for a strategy for drug safety surveillance congruent with existing literature on counterfeit medication. Zip codes with greater numbers of individuals age 65+ and greater numbers of ethnic white individuals were most correlated with receipt of a counterfeit Avastin notice. Geospatial visualisations designed in conjunction with statistical analysis of demographic variables appeared more capable of suggesting areas and populations that may be at risk for undetected counterfeit Avastin penetration. This study suggests that dual incorporation of statistical and geospatial analysis in surveillance of counterfeit medicine may be helpful in guiding efforts to prevent, detect and visualise counterfeit medicines penetrations in the US drug supply chain and other settings. Importantly, the information generated by these analyses could be utilised to identify at-risk populations associated with demographic characteristics

  14. Spurious and counterfeit drugs: a growing industry in the developing world.

    Science.gov (United States)

    Gautam, C S; Utreja, A; Singal, G L

    2009-05-01

    Spread of spurious/counterfeit/substandard drugs is a modern day menace which has been recognised internationally, especially so in developing countries. The problem assumes added significance in view of rapid globalisation. The market of spurious and counterfeit drugs is a well-organised, white collar crime. Poverty, high cost of medicines, lack of an official supply chain, legislative lacunae, easy accessibility to computerised printing technology, ineffective law enforcement machinery, and light penalties provide the counterfeiters with an enormous economic incentive without much risk. The consequences of the use of such medicines may vary from therapeutic failure to the occurrence of serious adverse events and even death. Proper drug quality monitoring, enforcement of laws and legislation, an effective and efficient regulatory environment, and awareness and vigilance on part of all stakeholders can help tackle this problem.

  15. Analytical challenges in drug counterfeiting and falsification-The NMR approach.

    Science.gov (United States)

    Holzgrabe, Ulrike; Malet-Martino, Myriam

    2011-06-25

    Counterfeiting of products is a global problem. As long as clothes, clocks, leather wear, etc. are faked there is no danger, but when it comes to drugs, counterfeiting can be life-threatening. In the last years sub-standard active pharmaceutical ingredients (APIs) were found more often even though the use of the quality-ensuring methods of international pharmacopoeias should have detected additional impurities and the low content of the API. Methods orthogonal to the separating methods used in the pharmacopoeias are necessary to find counterfeits. Beside Raman and NIR spectroscopies as well as powder X-ray analysis, NMR spectroscopy being a primary ratio method of measurement is highly suitable to identify and quantify a drug and its related substances as well as to recognize a drug of sub-standard quality. DOSY experiments are suitable to identify the ingredients of formulations and therefore to identify wrong and/or additional ingredients. This review gives an overview of the application of quantitative NMR spectroscopy and DOSY NMR in anticounterfeiting. Copyright © 2010 Elsevier B.V. All rights reserved.

  16. Antiretroviral therapy: current drugs.

    Science.gov (United States)

    Pau, Alice K; George, Jomy M

    2014-09-01

    The rapid advances in drug discovery and the development of antiretroviral therapy is unprecedented in the history of modern medicine. The administration of chronic combination antiretroviral therapy targeting different stages of the human immunodeficiency virus' replicative life cycle allows for durable and maximal suppression of plasma viremia. This suppression has resulted in dramatic improvement of patient survival. This article reviews the history of antiretroviral drug development and discusses the clinical pharmacology, efficacy, and toxicities of the antiretroviral agents most commonly used in clinical practice to date. Published by Elsevier Inc.

  17. Drug-laden 3D biodegradable label using QR code for anti-counterfeiting of drugs.

    Science.gov (United States)

    Fei, Jie; Liu, Ran

    2016-06-01

    Wiping out counterfeit drugs is a great task for public health care around the world. The boost of these drugs makes treatment to become potentially harmful or even lethal. In this paper, biodegradable drug-laden QR code label for anti-counterfeiting of drugs is proposed that can provide the non-fluorescence recognition and high capacity. It is fabricated by the laser cutting to achieve the roughness over different surface which causes the difference in the gray levels on the translucent material the QR code pattern, and the micro mold process to obtain the drug-laden biodegradable label. We screened biomaterials presenting the relevant conditions and further requirements of the package. The drug-laden microlabel is on the surface of the troches or the bottom of the capsule and can be read by a simple smartphone QR code reader application. Labeling the pill directly and decoding the information successfully means more convenient and simple operation with non-fluorescence and high capacity in contrast to the traditional methods. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. Three-dimensional quick response code based on inkjet printing of upconversion fluorescent nanoparticles for drug anti-counterfeiting

    Science.gov (United States)

    You, Minli; Lin, Min; Wang, Shurui; Wang, Xuemin; Zhang, Ge; Hong, Yuan; Dong, Yuqing; Jin, Guorui; Xu, Feng

    2016-05-01

    Medicine counterfeiting is a serious issue worldwide, involving potentially devastating health repercussions. Advanced anti-counterfeit technology for drugs has therefore aroused intensive interest. However, existing anti-counterfeit technologies are associated with drawbacks such as the high cost, complex fabrication process, sophisticated operation and incapability in authenticating drug ingredients. In this contribution, we developed a smart phone recognition based upconversion fluorescent three-dimensional (3D) quick response (QR) code for tracking and anti-counterfeiting of drugs. We firstly formulated three colored inks incorporating upconversion nanoparticles with RGB (i.e., red, green and blue) emission colors. Using a modified inkjet printer, we printed a series of colors by precisely regulating the overlap of these three inks. Meanwhile, we developed a multilayer printing and splitting technology, which significantly increases the information storage capacity per unit area. As an example, we directly printed the upconversion fluorescent 3D QR code on the surface of drug capsules. The 3D QR code consisted of three different color layers with each layer encoded by information of different aspects of the drug. A smart phone APP was designed to decode the multicolor 3D QR code, providing the authenticity and related information of drugs. The developed technology possesses merits in terms of low cost, ease of operation, high throughput and high information capacity, thus holds great potential for drug anti-counterfeiting.Medicine counterfeiting is a serious issue worldwide, involving potentially devastating health repercussions. Advanced anti-counterfeit technology for drugs has therefore aroused intensive interest. However, existing anti-counterfeit technologies are associated with drawbacks such as the high cost, complex fabrication process, sophisticated operation and incapability in authenticating drug ingredients. In this contribution, we developed a

  19. Chemical Analysis of Counterfeit Hepatitis C Drug Found in Japan.

    Science.gov (United States)

    Uchiyama, Nahoko; Kamakura, Hiroyuki; Masada, Sayaka; Tsujimoto, Takashi; Hosoe, Junko; Tokumoto, Hiroko; Maruyama, Takuro; Goda, Yukihiro; Hakamatsuka, Takashi

    2017-10-01

    In January 2017, counterfeits of the hepatitis C drug 'HARVONI ® Combination Tablets' (HARVONI ® ) were found at a pharmacy chain through unlicensed suppliers in Japan. A total of five lots of counterfeit HARVONI ® (samples 1-5) bottles were found, and the ingredients of the bottles were all in tablet form. Among them, two differently shaped tablets were present in two of the bottles (categorized as samples 2A, 2B, 4A, and 4B). We analyzed the total of seven samples by high-resolution LC-MS, GC-MS and NMR. In samples 2A, 3 and 4B, sofosbuvir, the active component of another hepatitis C drug, SOVALDI ® Tablets 400 mg (SOVALDI ® ), was detected. In sample 4A, sofosbuvir and ledipasvir, the active components of HARVONI ® , were found. A direct comparison of the four samples and genuine products showed that three samples (2A, 3, 4B) are apparently SOVALDI ® and that sample 2A is HARVONI ® . In samples 1 and 5, several vitamins but none of the active compounds usually found in HARVONI ® (i.e., sofosbuvir and ledipasvir) were detected. Our additional investigation indicates that these two samples are likely to be a commercial vitamin supplement distributed in Japan. Sample 2B, looked entirely different from HARVONI ® and contained several herbal constitutents (such as ephedrine and glycyrrhizin) that are used in Japanese Kampo formulations. A further analysis indicated that sample 2B is likely to be a Kampo extract tablet of Shoseiryuto which is distributed in Japan. Considering this case, it is important to be vigilant to prevent a recurrence of distribution of counterfeit drugs.

  20. Strategies and Systems-Level Interventions to Combat or Prevent Drug Counterfeiting: A Systematic Review of Evidence Beyond Effectiveness.

    Science.gov (United States)

    Fadlallah, Racha; El-Jardali, Fadi; Annan, Farah; Azzam, Hayat; Akl, Elie A

    2016-01-01

    A recent systematic review suggested that drug registrations and onsite quality inspections may be effective in reducing the prevalence of counterfeit and substandard drugs. However, simply replicating the most effective interventions is problematic, as it denotes implementing the intervention without further adaptation. The aim was to systematically review the evidence beyond effectiveness for systems-level interventions to combat or prevent drug counterfeiting. We conducted an extensive search, including an electronic search of 14 databases. We included studies examining the efficiency, feasibility, reliability, and economic outcomes of the interventions, as well as barriers and facilitators to their implementation. Two reviewers selected eligible studies and abstracted data in duplicate and independently. We synthesized the results narratively, stratified by type of intervention. Of 10,220 captured citations, 19 met our inclusion criteria. The findings suggest that the following may strengthen regulatory measures (e.g., registration): minimizing drug diversion, enhancing lines of communications, ensuring feedback on drug quality, and promoting strict licensing criteria. There is evidence that onsite quality surveillance and inspection systems may be efficient and cost-effective for preliminary testing of large samples of drugs. Laws and legislation need to be specific to counterfeit drugs, include firm penalties, address online purchasing of drugs, and be complemented by education of judges and lawyers. Public awareness and education should rely on multiple platforms and comprehensive and dedicated content. While product authentication technologies may be efficient and reliable in detecting counterfeit drugs in the supply chain, they require a strong information system infrastructure. As for pharmacovigilance systems, it is critical to tackle the issue of underreporting, to enhance their chances of success. Several factors are critical to the successful design

  1. Examining the production costs of antiretroviral drugs.

    Science.gov (United States)

    Pinheiro, Eloan; Vasan, Ashwin; Kim, Jim Yong; Lee, Evan; Guimier, Jean Marc; Perriens, Joseph

    2006-08-22

    To present direct manufacturing costs and price calculations of individual antiretroviral drugs, enabling those responsible for their procurement to have a better understanding of the cost structure of their production, and to indicate the prices at which these antiretroviral drugs could be offered in developing country markets. Direct manufacturing costs and factory prices for selected first and second-line antiretroviral drugs were calculated based on cost structure data from a state-owned company in Brazil. Prices for the active pharmaceutical ingredients (API) were taken from a recent survey by the World Health Organization (WHO). The calculated prices for antiretroviral drugs are compared with quoted prices offered by privately-owned, for-profit manufacturers. The API represents the largest component of direct manufacturing costs (55-99%), while other inputs, such as salaries, equipment costs, and scale of production, have a minimal impact. The calculated prices for most of the antiretroviral drugs studied fall within the lower quartile of the range of quoted prices in developing country markets. The exceptions are those drugs, primarily for second-line therapy, for which the API is either under patent, in short supply, or in limited use in developing countries (e.g. abacavir, lopinavir/ritonavir, nelfinavir, saquinavir). The availability of data on the cost of antiretroviral drug production and calculation of factory prices under a sustainable business model provide benchmarks that bulk purchasers of antiretroviral drugs could use to negotiate lower prices. While truly significant price decreases for antiretroviral drugs will depend largely on the future evolution of API prices, the present study demonstrates that for several antiretroviral drugs price reduction is currently possible. Whether or not these reductions materialize will depend on the magnitude of indirect cost and profit added by each supplier over the direct production costs. The ability to

  2. Health risks of counterfeit pharmaceuticals.

    Science.gov (United States)

    ten Ham, Martijn

    2003-01-01

    Pharmaceutical products are not exempt from the practice of counterfeiting. In recent years, many reports have become available demonstrating the presence of fake medicines on the market. Several studies have demonstrated that they are quite often of bad quality. It is estimated that 5% of all world trade in branded goods is counterfeit, leading to huge financial losses for the pharmaceutical industry. But much more important, from a public health point of view, is that history has shown that such products may lead to a great health risk. The essence of counterfeit products and the reason they are so dangerous is the complete absence of quality control, since they are often indistinguishable from the genuine product. The existence of counterfeit drugs has long been ignored both by the pharmaceutical industry and by drug regulatory authorities. At present initiatives are being taken, nationally and internationally, to curb counterfeiting. It is now realised that a strong regulatory agency is essential, but the initiatives can only be successful if all parties concerned actively co-operate.

  3. Combined antiretroviral and anti- tuberculosis drug resistance ...

    African Journals Online (AJOL)

    these epidemics, many challenges remain.[3] Antiretroviral and anti-TB drug resistance pose considerable threats to the control of these epidemics.[4,5]. The breakdown in HIV/TB control within prisons is another emerging threat.[6,7] We describe one of the first reports of combined antiretroviral and anti-TB drug resistance ...

  4.  The potential nephrotoxicity of antiretroviral drugs

    Directory of Open Access Journals (Sweden)

    Zofia Marchewka

    2012-09-01

    Full Text Available  The intensive studies carried out in many scientific laboratories and the efforts of numerous pharmaceutical companies have led to the development of drugs which are able to effectively inhibitHIV proliferation. At present, a number of antiretroviral agents with different mechanisms of actionare available. Unfortunately, long-term use of antiretroviral drugs, however, does not remainindifferent to the patient and can cause significant side effects.In the present work, the antiretroviral drugs with a nephrotoxicity potential most commonly usedin clinical practice are described. In the review attention has also been focused on the nephropathyresulting from the HIV infection alone and the influence of genetic factors on the occurrenceof pathological changes in the kidney.

  5. An Examination of Income Effect on Consumers' Ethical Evaluation of Counterfeit Drugs Buying Behaviour: A Cross-Sectional Study in Qatar and Sudan.

    Science.gov (United States)

    Alfadl, Abubakr Abdelraouf; Ibrahim, Mohamed Izham Mohamed; Maraghi, Fatima Abdulla; Mohammad, Khadijah Shhab

    2016-09-01

    There are limited studies on consumer behaviour toward counterfeit products and the determining factors that motivate willingness to purchase counterfeit items. This study aimed to fill this literature gap through studying differences in individual ethical evaluations of counterfeit drug purchase and whether that ethical evaluation affected by difference in income. It is hypothesized that individuals with lower/higher income make a more/less permissive evaluation of ethical responsibility regarding counterfeit drug purchase. To empirically test the research assumption, a comparison was made between people who live in the low-income country Sudan and people who live in the high-income country Qatar. The study employed a face-to-face structured interview survey methodology to collect data from 1,170 subjects and the Sudanese and Qatari samples were compared using independent t-test at alpha level of 0.05 employing SPSS version 22.0. Sudanese and Qatari individuals were significantly different on all items. Sudanese individuals scored below 3 for all Awareness of Societal Consequences (ASC) items indicating that they make more permissive evaluation of ethical responsibility regarding counterfeit drug purchase. Both groups shared a basic positive moral agreement regarding subjective norm indicating that influence of income is not evident. Findings indicate that low-income individuals make more permissive evaluation of ethical responsibility regarding counterfeit drugs purchase when highlighting awareness of societal consequences used as a deterrent tool, while both low and high-income individuals share a basic positive moral agreement when subjective norm dimension is exploited to discourage unethical buying behaviour.

  6. Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment

    Science.gov (United States)

    Mackey, Tim K.; Liang, Bryan A.; York, Peter; Kubic, Thomas

    2015-01-01

    Counterfeit medicines are a global public health risk. We assess counterfeit reports involving the legitimate supply chain using 2009–2011 data from the Pharmaceutical Security Institute Counterfeit Incident System (PSI CIS) database that uses both open and nonpublic data sources. Of the 1,510 identified CIS reports involving counterfeits, 27.6% reported China as the source country of the incident/detection. Further, 51.3% were reported as counterfeit but the specific counterfeit subcategory was not known or verifiable. The most prevalent therapeutic category was anti-infectives (21.1%) with most reports originating from health-related government agencies. Geographically, Asian and Latin American regions and, economically, middle-income markets were most represented. A total of 127 (64.8%) of a total of 196 countries had no legitimate supply chain CIS counterfeit reports. Improvements in surveillance, including detection of security breaches, data collection, analysis, and dissemination are urgently needed to address public health needs to combat the global counterfeit medicines trade. PMID:25897059

  7. Role of the pharmacist in preventing distribution of counterfeit medications.

    Science.gov (United States)

    Chambliss, Walter G; Carroll, Wesley A; Kennedy, Daniel; Levine, Donald; Moné, Michael A; Ried, L Douglas; Shepherd, Marv; Yelvigi, Mukund

    2012-01-01

    To provide an overview of the counterfeit medication problem and recommendations of a joint American Pharmacists Association (APhA) Academy of Pharmaceutical Research and Science and APhA Academy of Pharmacy Practice and Management taskforce. SciFinder and PubMed were searched from 1980 to March 2011 using the following keywords: counterfeit drug product, counterfeit medications, drug product authentication, drug product verification, and track-and-trace. Publications, presentations, and websites of organizations that research the counterfeit medication problem in the United States and other countries were reviewed. A representative from the security division of a pharmaceutical manufacturer and a representative from a supplier of anticounterfeiting technologies gave presentations to the taskforce. The taskforce recommends that pharmacists (1) purchase medications from known, reliable sources; (2) warn patients of the dangers of purchasing medications over the Internet; (3) confirm with distributors that products were purchased from manufacturers or other reliable sources; (4) monitor counterfeit product alerts; (5) examine products for suspicious appearance; (6) work with the pharmaceutical industry, distributors, and the Food and Drug Administration (FDA) to close gaps in the supply chain, especially for drugs in short supply; (7) use scanning technology in the pharmacy as part of a prescription verification process; (8) educate themselves, coworkers, and patients about the risks of counterfeit medications; and (9) report suspicious medications to FDA, the distributor, and the manufacturer. The consequence of a patient receiving a counterfeit medication in the United States could be catastrophic, and pharmacists must play an active role in preventing such an event from occurring.

  8. Counterfeit medicines in Peru: a retrospective review (1997-2014).

    Science.gov (United States)

    Medina, Edwin; Bel, Elvira; Suñé, Josep María

    2016-04-04

    To consolidate and assess information on counterfeit medicines subject to pharmaceutical alerts issued by the Peruvian Medicines Regulatory Authority over 18 years (1997-2014) of health monitoring and enforcement. A retrospective review of drug alerts. A search of the website of the General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Ministry of Health of Peru for drug alerts issued between 1997 and 2014. Drug alerts related to counterfeit medicines. A total of 669 DIGEMID alerts were issued during the study period, 354 (52.91%) of which cover 1738 cases of counterfeit medicines (many alerts deal with several cases at a time). 1010 cases (58.11%) involved pharmaceutical establishments and 349 (20.08%) involved non-pharmaceutical commercial outlets. In 126 cases (7.25%), counterfeit medicines were seized in an unauthorised trade (without any marketing authorisation); in 253 cases (14.56%) the type of establishment or business associated with the seized product was not identified. Counterfeit medicines are a serious public health problem in Peru. A review of the data cannot determine whether counterfeit medicines in Peru increased during the study period, or if monitoring by different government health agencies highlighted the magnitude of the problem by providing more evidence. The problem is clearly structural, since the majority of cases (58.11% of the total) were detected in legitimate supply chains. Most counterfeit medicines involve staple pharmaceutical products and common dosage forms. Considerable work remains to be done to control the serious problem of counterfeit medicines in Peru. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  9. Bioanalysis, metabolism & clinical pharmacology of antiretroviral drugs

    NARCIS (Netherlands)

    Heine, R. ter

    2009-01-01

    The aims of all studies described in this thesis were to develop new bioanalytical and more patient friendly methods for studying the clinical pharmacology of antiretroviral drugs and to ultimately improve antiretroviral treatment.

  10. [Non-antiretroviral drugs uses among HIV-infected persons receiving antiretroviral therapy in Senegal: Costs and factors associated with prescription].

    Science.gov (United States)

    Diouf, A; Youbong, T J; Maynart, M; Ndoye, M; Diéye, F L; Ndiaye, N A; Koita-Fall, M B; Ndiaye, B; Seydi, M

    2017-08-01

    In addition to antiretroviral therapy, non-antiretroviral drugs are necessary for the appropriate care of people living with HIV. The costs of such drugs are totally or partially supported by the people living with HIV. We aimed to evaluate the overall costs, the costs supported by the people living with HIV and factors associated with the prescription of non-antiretroviral drugs in people living with HIV on antiretroviral therapy in Senegal. We conducted a retrospective cohort study on 331 people living with HIV who initiated antiretroviral therapy between 2009 and 2011 and followed until March 2012. The costs of non-antiretroviral drugs were those of the national pharmacy for essential drugs; otherwise they were the lowest costs in the private pharmacies. Associated factors were identified through a logistic regression model. The study population was 61 % female. At baseline, 39 % of patients were classified at WHO clinical stage 3 and 40 % at WHO clinical stage 4. Median age, body mass index and CD4 cells count were 41 years, 18kg/m 2  and 93 cells/μL, respectively. After a mean duration of 11.4 months of antiretroviral therapy, 85 % of patients received at least one prescription for a non-antiretroviral drug. Over the entire study period, the most frequently prescribed non-antiretroviral drugs were cotrimoxazole (78.9 % of patients), iron (33.2 %), vitamins (21.1 %) and antibiotics (19.6 %). The mean cost per patient was 34 Euros and the mean cost supported per patient was 14 Euros. The most expensive drugs per treated patient were antihypertensives (168 Euros), anti-ulcer agents (12 Euros), vitamins (8.5 Euros) and antihistamines (7 Euros). The prescription for a non-antiretroviral drug was associated with advanced clinical stage (WHO clinical stage 3/4 versus stage 1/2): OR=2.25; 95 % CI=1.11-4.57 and viral type (HIV-2 versus HIV-1/HIV-1+HIV-2): OR=0.36; 95 % CI=0.14-0.89. Non-antiretroviral drugs are frequently prescribed to

  11. NEW DRUGS NEW TARGETS AND NOVEL ANTIRETROVIRALS

    African Journals Online (AJOL)

    2005-11-02

    Nov 2, 2005 ... Highly active antiretroviral therapy (HAART) has to date been based on use of a triple combination of drugs chosen from three classes of antiretrovirals (ARVs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs).

  12. Severe hypoglycaemia associated with ingesting counterfeit medication.

    Science.gov (United States)

    Chaubey, Santosh K; Sangla, Kunwarjit S; Suthaharan, Emershia N; Tan, Yong M

    2010-06-21

    Cross-border importation of traditional and prescription medications is common, and many of these drugs are not approved by the Australian Therapeutic Goods Administration. Furthermore, counterfeit versions of prescription medications are also available (eg, weight-loss medications, anabolic steroids, and medications to enhance sexual performance). We describe a 54-year-old man with the first Australian case of severe hypoglycaemia induced by imported, laboratory-confirmed counterfeit Cialis. This serves to remind medical practitioners that counterfeit medication may be the cause of severe hypoglycaemia (or other unexplained illness).

  13. Antiretroviral drug susceptibility among drug-naive adults with recent HIV infection in Rakai, Uganda.

    Science.gov (United States)

    Eshleman, Susan H; Laeyendecker, Oliver; Parkin, Neil; Huang, Wei; Chappey, Colombe; Paquet, Agnes C; Serwadda, David; Reynolds, Steven J; Kiwanuka, Noah; Quinn, Thomas C; Gray, Ronald; Wawer, Maria

    2009-04-27

    To analyze antiretroviral drug susceptibility in HIV from recently infected adults in Rakai, Uganda, prior to the availability of antiretroviral drug treatment. Samples obtained at the time of HIV seroconversion (1998-2003) were analyzed using the GeneSeq HIV and PhenoSense HIV assays (Monogram Biosciences, Inc., South San Francisco, California, USA). Test results were obtained for 104 samples (subtypes: 26A, 1C, 66D, 9A/D, 1C/D, 1 intersubtype recombinant). Mutations used for genotypic surveillance of transmitted antiretroviral drug resistance were identified in six samples: three had nucleoside reverse transcriptase inhibitor (NRTI) surveillance mutations (two had M41L, one had K219R), and three had protease inhibitor surveillance mutations (I47V, F53L, N88D); none had nonnucleoside reverse transcriptase inhibitor (NNRTI) surveillance mutations. Other resistance-associated mutations were identified in some samples. However, none of the samples had a sufficient number of mutations to predict reduced antiretroviral drug susceptibility. Ten (9.6%) of the samples had reduced phenotypic susceptibility to at least one drug (one had partial susceptibility to didanosine, one had nevirapine resistance, and eight had resistance or partial susceptibility to at least one protease inhibitor). Fifty-three (51%) of the samples had hypersusceptibility to at least one drug (seven had zidovudine hypersusceptibility, 28 had NNRTI hypersusceptibility, 34 had protease inhibitor hypersusceptibility). Delavirdine hypersusceptibility was more frequent in subtype A than D. In subtype D, efavirenz hypersusceptibility was associated with substitutions at codon 11 in HIV-reverse transcriptase. Phenotyping detected reduced antiretroviral drug susceptibility and hypersusceptibility in HIV from some antiretroviral-naive Ugandan adults that was not predicted by genotyping. Phenotyping may complement genotyping for analysis of antiretroviral drug susceptibility in populations with nonsubtype B

  14. Abuse of antiretroviral drugs combined with addictive drugs by ...

    African Journals Online (AJOL)

    Reports of the use of antiretroviral drugs (ARVs) to produce a highly addictive drug called nyaope or whoonga are of major concern as ARVs are easily accessible in sub-Saharan Africa, including to pregnant women. Use of illicit drugs by pregnant women may result in serious adverse effects in their infants. We have ...

  15. Substandard, Spurious, Falsely-Labelled, Falsified and Counterfeit (SSFFC Drugs: Time to Take a Bitter Pill

    Directory of Open Access Journals (Sweden)

    Geetha Mani

    2016-10-01

    Full Text Available Substandard, Spurious, Falsely-Labelled, Falsified and Counterfeit (SSFFC drugs are an emerging public health concern in India. With one of the huge pharmaceutical sectors in the world, India has a varied prevalence of SSSFC drugs ranging from 0.04% to 34% according to various studies. Apart from severe health consequences, SSSFC drugs also weaken community's trust in the health care system. India is tackling the epidemic of SSSFC drugs through various existing and new regulatory measures. Considering the calamitous consequences of this silent epidemic, it is time to prescribe a bitter pill.

  16. Anti-Counterfeiting

    Science.gov (United States)

    Tuyls, Pim; Guajardo, Jorge; Batina, Lejla; Kerins, Tim

    Counterfeiting of goods is becoming a very huge problem for our society. It not only has a global economic impact, but it also poses a serious threat to our global safety and health. Currently, global economic damage across all industries due to the counterfeiting of goods is estimated at over 600 billion annually [2]. In the United States, seizure of counterfeit goods has tripled in the last 5 years, and in Europe, over 100 million pirated and counterfeit goods were seized in 2004. Fake products cost businesses in the United Kingdom approximately 17 billion [2]. In India, 15% of fast-moving consumer goods and 38% of auto parts are counterfeit. Other industries in which many goods are being counterfeit are the toy industry, content and software, cosmetics, publishing, food and beverages, tobacco, apparel, sports goods, cards, and so forth.

  17. Scale development on consumer behavior toward counterfeit drugs in a developing country: a quantitative study exploiting the tools of an evolving paradigm.

    Science.gov (United States)

    Alfadl, Abubakr A; Ibrahim, Mohamed Izham b Mohamed; Hassali, Mohamed Azmi Ahmad

    2013-09-11

    Although desperate need and drug counterfeiting are linked in developing countries, little research has been carried out to address this link, and there is a lack of proper tools and methodology. This study addresses the need for a new methodological approach by developing a scale to aid in understanding the demand side of drug counterfeiting in a developing country. The study presents a quantitative, non-representative survey conducted in Sudan. A face-to-face structured interview survey methodology was employed to collect the data from the general population (people in the street) in two phases: pilot (n = 100) and final survey (n = 1003). Data were analyzed by examining means, variances, squared multiple correlations, item-to-total correlations, and the results of an exploratory factor analysis and a confirmatory factor analysis. As an approach to scale purification, internal consistency was examined and improved. The scale was reduced from 44 to 41 items and Cronbach's alpha improved from 0.818 to 0.862. Finally, scale items were assessed. The result was an eleven-factor solution. Convergent and discriminant validity were demonstrated. The results of this study indicate that the "Consumer Behavior Toward Counterfeit Drugs Scale" is a valid, reliable measure with a solid theoretical base. Ultimately, the study offers public health policymakers a valid measurement tool and, consequently, a new methodological approach with which to build a better understanding of the demand side of counterfeit drugs and to develop more effective strategies to combat the problem.

  18. Substandard and counterfeit medicines: a systematic review of the literature

    Science.gov (United States)

    Almuzaini, Tariq; Choonara, Imti; Sammons, Helen

    2013-01-01

    Objective To explore the evidence available of poor-quality (counterfeit and substandard) medicines in the literature. Design Systematic review. Data sources Databases used were EMBASE, MEDLINE, PubMed and the International Pharmaceutical Abstracts, including articles published till January 2013. Eligibility criteria Prevalence studies containing original data. WHO definitions (1992) used for counterfeit and substandard medicines. Study appraisal and synthesis Two reviewers independently scored study methodology against recommendations from the MEDQUARG Checklist. Studies were classified according to the World Bank classification of countries by income. Data extraction Data extracted: place of study; type of drugs sampled; sample size; percentage of substandard/counterfeit medicines; formulations included; origin of the drugs; chemical analysis and stated issues of counterfeit/substandard medicines. Results 44 prevalence studies were identified, 15 had good methodological quality. They were conducted in 25 different countries; the majority were in low-income countries (11) and/or lower middle-income countries (10). The median prevalence of substandard/counterfeit medicines was 28.5% (range 11–48%). Only two studies differentiated between substandard and counterfeit medicines. Prevalence data were limited to antimicrobial drugs (all 15 studies). 13 studies involved antimalarials, 6 antibiotics and 2 other medications. The majority of studies (93%) contained samples with inadequate amounts of active ingredients. The prevalence of substandard/counterfeit antimicrobials was significantly higher when purchased from unlicensed outlets (pcounterfeit medicines. Most studies assessed only a single therapeutic class of antimicrobials. Conclusions The prevalence of poor-quality antimicrobial medicines is widespread throughout Africa and Asia in lower income countries and lower middle-income countries . The main problem identified was inadequate amounts of the active

  19. [Anti-counterfeit activities of pharmaceutical companies in Japan: for patient safety].

    Science.gov (United States)

    Shofuda, Ken-ichi; Aragane, Katsumi; Igari, Yasutaka; Matsumoto, Kinya; Ito, Kazuya

    2014-01-01

    Global spread of counterfeit medicines is an imminent threat for the patients' safety. Although major targets of counterfeits are still erectile dysfunction (ED) drugs in the industrialized countries, including Japan, anti-cancer agents and some medicines for metabolic syndromes are also being counterfeited and circulated to the market mainly through the Internet. Due to the global expansion of the business, pharmaceutical companies based in Japan are suffering from the damage of counterfeits, illegal sales including diversion, and thefts, which have never been experienced in the conventional domestic market. We, pharmaceutical companies, must be responsible for the prevention of the prevalence because our mission is to deliver effective and safe medicine to patients. For this end, we are taking necessary actions including, 1. Forestalling counterfeit, falsification and illicit trade: Measures to prevent counterfeiting are taken by introducing anti-counterfeit technologies to the packaging and tablets on a risk basis. It is also important to establish supply chain security on a global scale. 2. Finding out counterfeits and cooperating crackdown: We are conducting market and internet surveillances when high risk products are sold in high risk markets. The outcome of the criminal investigation is reported to authorities and police if necessary. 3. Conducting educational campaign to medical staff or patients: For example, four companies which manufacture and sell ED drug in Japan are collaboratively continuing activities to raise the awareness of the danger of Internet purchase. To deliver effective and safe medicines stably and globally, pharmaceutical companies extend comprehensive measures against counterfeit and illicit trading.

  20. First-line antiretroviral drug discontinuations in children.

    Directory of Open Access Journals (Sweden)

    Melony Fortuin-de Smidt

    Full Text Available There are a limited number of paediatric antiretroviral drug options. Characterising the long term safety and durability of different antiretrovirals in children is important to optimise management of HIV infected children and to determine the estimated need for alternative drugs in paediatric regimens. We describe first-line antiretroviral therapy (ART durability and reasons for discontinuations in children at two South African ART programmes, where lopinavir/ritonavir has been recommended for children <3 years old since 2004, and abacavir replaced stavudine as the preferred nucleoside reverse transcriptase inhibitor in 2010.We included children (<16 years at ART initiation who initiated ≥3 antiretrovirals between 2004-2014 with ≥1 follow-up visit on ART. We estimated the incidence of first antiretroviral discontinuation using Kaplan-Meier analysis. We determined the reasons for antiretroviral discontinuations using competing risks analysis. We used Cox regression to identify factors associated with treatment-limiting toxicity.We included 3579 children with median follow-up duration of 41 months (IQR 14-72. At ART initiation, median age was 44 months (IQR 13-89 and median CD4 percent was 15% (IQR 9-21%. At three and five years on ART, 72% and 26% of children respectively remained on their initial regimen. By five years on ART, the most common reasons for discontinuations were toxicity (32%, treatment failure (18%, treatment simplification (5%, drug interactions (3%, and other or unspecified reasons (18%. The incidences of treatment limiting toxicity were 50.6 (95% CI 46.2-55.4, 1.6 (0.5-4.8, 2.0 (1.2-3.3, and 1.3 (0.6-2.8 per 1000 patient years for stavudine, abacavir, efavirenz and lopinavir/ritonavir respectively.While stavudine was associated with a high risk of treatment-limiting toxicity, abacavir, lopinavir/ritonavir and efavirenz were well-tolerated. This supports the World Health Organization recommendation to replace stavudine with

  1. Caveat oncologist: clinical findings and consequences of distributing counterfeit erythropoietin in the United States.

    Science.gov (United States)

    Qureshi, Zaina P; Norris, Leann; Sartor, Oliver; McKoy, June M; Armstrong, John; Raisch, Dennis W; Garg, Vishvas; Stafkey-Mailey, Dana; Bennett, Charles Lee

    2012-03-01

    Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals. Information was obtained on patients who received counterfeit erythropoietin, its distribution, and criminal investigations into counterfeiting networks. Interview sources included a physician, an attorney, employees of the Florida Department of Health and Human Services and the US Food and Drug Administration's (FDA) Office of Criminal Investigation, manufacturers, and wholesalers. Other sources included the book "Dangerous Doses," LexisNexis (search terms "counterfeit" and "erythropoietin") and the FDA database. Counterfeit product consisted of 2,000 U vials with counterfeit labels denoting 40,000 U. The counterfeiters, in collaboration with a Miami pharmacy, purchased 110,000 erythropoietin 2,000 U vials and affixed counterfeit labels to each vial. Products were then sold via the pharmaceutical "gray market" to wholesalers, then pharmacy chains. Investigations by Florida government officials implicated 17 persons, all of whom were found guilty of trafficking in counterfeit pharmaceuticals. Despite the large size of the operation, the FDA received reports of only 12 patients who had received counterfeit erythropoietin and detailed information for only two individuals. A 17-year-old liver transplant recipient and a 61-year-old patient with breast cancer experienced loss of efficacy after receiving counterfeit erythropoietin. Wider use of FDA anticounterfeit initiatives, limiting pharmaceutical suppliers to reputable distributors, and educating providers and patients about signs of counterfeit drugs can improve the safety of cancer pharmaceuticals.

  2. Effect of Antiretroviral Drug (arved) on the Kidney in Albino Rat ...

    African Journals Online (AJOL)

    African studies on effect of antiretroviral drugs on the kidney are limited resulting to scanty information on the safety of these drugs. This study was therefore designed to evaluate the effects of antiretroviral drugs arved®, on creatinine, urea, potassium and sodium ions as well as histological effect on the kidney. A total of fifty ...

  3. Adherence to anti-retroviral drugs in pregnant and lactating HIV ...

    African Journals Online (AJOL)

    Background: Anti-retroviral drugs reduce morbidity and mortality due to HIV and prevent transmission from mother to child. But compliance on anti-retroviral treatment is an essential element for the success of therapeutic goals. Objective: To assess the level of compliance of anti-retroviral treatment in pregnant and lactating ...

  4. Lithographically encoded polymer microtaggant using high-capacity and error-correctable QR code for anti-counterfeiting of drugs.

    Science.gov (United States)

    Han, Sangkwon; Bae, Hyung Jong; Kim, Junhoi; Shin, Sunghwan; Choi, Sung-Eun; Lee, Sung Hoon; Kwon, Sunghoon; Park, Wook

    2012-11-20

    A QR-coded microtaggant for the anti-counterfeiting of drugs is proposed that can provide high capacity and error-correction capability. It is fabricated lithographically in a microfluidic channel with special consideration of the island patterns in the QR Code. The microtaggant is incorporated in the drug capsule ("on-dose authentication") and can be read by a simple smartphone QR Code reader application when removed from the capsule and washed free of drug. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  5. Caveat Oncologist: Clinical Findings and Consequences of Distributing Counterfeit Erythropoietin in the United States

    Science.gov (United States)

    Qureshi, Zaina P.; Norris, LeAnn; Sartor, Oliver; McKoy, June M.; Armstrong, John; Raisch, Dennis W.; Garg, Vishvas; Stafkey-Mailey, Dana; Bennett, Charles Lee

    2012-01-01

    Purpose: Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals. Materials and Methods: Information was obtained on patients who received counterfeit erythropoietin, its distribution, and criminal investigations into counterfeiting networks. Interview sources included a physician, an attorney, employees of the Florida Department of Health and Human Services and the US Food and Drug Administration's (FDA) Office of Criminal Investigation, manufacturers, and wholesalers. Other sources included the book “Dangerous Doses,” LexisNexis (search terms “counterfeit” and “erythropoietin”) and the FDA database. Results: Counterfeit product consisted of 2,000 U vials with counterfeit labels denoting 40,000 U. The counterfeiters, in collaboration with a Miami pharmacy, purchased 110,000 erythropoietin 2,000 U vials and affixed counterfeit labels to each vial. Products were then sold via the pharmaceutical “gray market” to wholesalers, then pharmacy chains. Investigations by Florida government officials implicated 17 persons, all of whom were found guilty of trafficking in counterfeit pharmaceuticals. Despite the large size of the operation, the FDA received reports of only 12 patients who had received counterfeit erythropoietin and detailed information for only two individuals. A 17-year-old liver transplant recipient and a 61-year-old patient with breast cancer experienced loss of efficacy after receiving counterfeit erythropoietin. Conclusion: Wider use of FDA anticounterfeit initiatives, limiting pharmaceutical suppliers to reputable distributors, and educating providers and patients about signs of counterfeit drugs can improve the safety of cancer pharmaceuticals. PMID:23077434

  6. [Sustainability of Brazilian policy for access to antiretroviral drugs].

    Science.gov (United States)

    Grangeiro, Alexandre; Teixeira, Luciana; Bastos, Francisco I; Teixeira, Paulo

    2006-04-01

    The expense of acquiring antiretroviral drugs in Brazil has given rise to debate about the sustainability of the policy of universal access to AIDS medications, despite the evident benefits. The objective of this study was to analyze the evolution of the Ministry of Health's spending on acquiring antiretroviral drugs from 1998 to 2005, the determining factors and the medium-term sustainability of this policy (2006-2008). The study on the evolution of spending on antiretrovirals included analysis of their prices, the year-by-year expenditure, the number of patients utilizing the medication, the mean expenditure per patient and the strategies for reducing the prices maintained during this period. To analyze the sustainability of the policy for access to antiretrovirals, the cost of acquiring the drugs over the period from 2006 to 2008 was estimated, along with the proportion of gross domestic product and federal health expenditure represented by this spending. The data were collected from the Ministry of Health, the Brazilian Institute for Geography and Statistics (IBGE) and the Ministry of Planning. The expenditure on antiretrovirals increased by 66% in 2005, breaking the declining trend observed over the period from 2000 to 2004. The main factors associated with this increase were the weakening of the national generics industry and the unsatisfactory results from the process of negotiating with pharmaceutical companies. The Brazilian policy for universal access is unsustainable at the present growth rates of the gross domestic product, unless the country compromises its investments in other fields.

  7. Use of non-antiretroviral drugs among individuals with and without HIV-infection

    DEFF Research Database (Denmark)

    Rasmussen, Line D; Kronborg, Gitte; Larsen, Carsten S

    2017-01-01

    AIM: We investigated the use of non-antiretroviral drugs in the HIV-infected compared to the general population. METHODS: From the Danish HIV Cohort Study, we identified all HIV-infected individuals older than 18 years at HIV diagnosis who received care in Denmark through 1995-2013 and reported...... no injection drug abuse or hepatitis C infection. Population controls were identified from The Danish Civil Registration System and matched on age and gender (5:1). We analyzed the proportion of individuals who redeemed 0-1, 2-4, 5-9, or 10 or more non-antiretroviral drugs. Data were analyzed according...... to calendar time, age, time from initiation of combination antiretroviral therapy (cART) and stratified by gender, geographical origin and route of HIV transmission. We further analyzed the use of the 25 most used non-antiretroviral drug classes. RESULTS: We identified 4,928 HIV-infected individuals (median...

  8. On the Counterfeiting Battlefield

    DEFF Research Database (Denmark)

    Beukel, Karin; Rullani, Francesco

    The protection of firms' identity is one of the main problems raised by the diffusion of counterfeit products. Firms protect their identity by fighting counterfeiters in their main and ancillary markets, as well as against diffusion of dangerous counterfeit products that can damage their brand...... and reputation. We describe the strategies of the firm and of the counterfeiters in these two contexts, and test our hypotheses using a unique dataset reporting 3333 battles taken by a high-tech firm against more than 2000 counterfeiters in 75 countries over a 6-year period. We find broad support for our...... hypotheses on the strategic behavior of the firm and of the counterfeiters, highlighting the difficulties firms find in protecting their main markets, and their advantages in limiting the diffusion of dangerous counterfeit products...

  9. Class of Antiretroviral Drugs and the Risk of Myocardial Infarction

    DEFF Research Database (Denmark)

    Friis-Møller, Nina; Reiss, P; Sabin, CA

    2007-01-01

    BACKGROUND: We have previously demonstrated an association between combination antiretroviral therapy and the risk of myocardial infarction. It is not clear whether this association differs according to the class of antiretroviral drugs. We conducted a study to investigate the association of cumu...

  10. Prevalence of counterfeit anthelminthic medicines: a cross-sectional survey in Cambodia.

    Science.gov (United States)

    Khan, Mohiuddin Hussain; Okumura, Junko; Sovannarith, Tey; Nivanna, Nam; Akazawa, Manabu; Kimura, Kazuko

    2010-05-01

    To assess the prevalence of counterfeit anthelminthic medicines in Cambodia, and to determine influential factors. Commonly used anthelminthic medicines were collected from private drug outlets. Medicines were carefully observed including their registration labelling, and their authenticity was investigated with the manufacturers and the Medicines Regulatory Authorities. Samples were analysed by High-Performance Liquid Chromatography at the National Health Product Quality Control Centre, Cambodia. Two hundred and three samples of anthelminthics were collected from 137 drug stores. Domestic products constituted 36.9%. Of 196 samples which were verified for registration, 15.8% were not registered. Of 165 samples successfully investigated for their authenticity, 7 (4.2%) were identified as counterfeit. All of these medicines were purchased in open packs or containers, and most of them were foreign manufactured and/or without registration. The results of our survey urge strict implementation of drug registration and vigilance on the availability of unregistered medicines to combat counterfeit medicines in Cambodia.

  11. TRANSPORT OF COUNTERFEIT GOODS

    Directory of Open Access Journals (Sweden)

    Dagmar Babčanová

    2014-09-01

    Full Text Available The paper is focused on a current problem of transport of counterfeit goods in the European Union. Counterfeiting has a strong influence on the distribution organizations worldwide because most of counterfeit goods threaten the health and safety of consumers. Counterfeiting is a serious problem in the world economy today. The purpose of this paper is to point out the danger of counterfeiting in connection with the transport of Intellectual Property (IP rights - infringing goods. Background of the paper’s content is based on secondary data research of publicly available sources - international statistics and world reports.

  12. Antiretroviral Drugs Used in the Treatment of HIV Infection

    Science.gov (United States)

    ... HIV/AIDS Treatment Antiretroviral drugs used in the treatment of HIV infection Share Tweet Linkedin Pin it More sharing ... Pin it Email Print Drugs Used in the Treatment of HIV Infection All FDA-approved medicines used in the ...

  13. Potential drug interactions in patients given antiretroviral therapy.

    Science.gov (United States)

    Santos, Wendel Mombaque Dos; Secoli, Silvia Regina; Padoin, Stela Maris de Mello

    2016-11-21

    to investigate potential drug-drug interactions (PDDI) in patients with HIV infection on antiretroviral therapy. a cross-sectional study was conducted on 161 adults with HIV infection. Clinical, socio demographic, and antiretroviral treatment data were collected. To analyze the potential drug interactions, we used the software Micromedex(r). Statistical analysis was performed by binary logistic regression, with a p-value of ≤0.05 considered statistically significant. of the participants, 52.2% were exposed to potential drug-drug interactions. In total, there were 218 potential drug-drug interactions, of which 79.8% occurred between drugs used for antiretroviral therapy. There was an association between the use of five or more medications and potential drug-drug interactions (p = 0.000) and between the time period of antiretroviral therapy being over six years and potential drug-drug interactions (p central nervous and cardiovascular systems, but also can interfere in tests used for detection of HIV resistance to antiretroviral drugs. investigar potenciais interações droga-droga (PDDI) em pacientes infectados com HIV em terapia de antirretroviral. um estudo de corte transversal foi conduzido em 161 pessoas infectadas com o HIV. Dados de tratamentos clínicos, sociodemográficos e antirretrovirais foram coletados. Para analisar a possível interação medicamentosa, nós usamos o software Micromedex(r). A análise estatística foi feita por regressão logística binária, com um valor P de ≤0.05, considerado estatisticamente significativo. dos participantes, 52.2% foram expostos a potenciais interações droga-droga. No total, houve 218 interações droga-droga, das quais 79.8% ocorreram entre drogas usadas para a terapia antirretroviral. Houve uma associação entre o uso de cinco ou mais medicamentos e possíveis interações droga-droga (p = 0.000), e entre o período de tempo de terapia antirretroviral acima de seis anos e possíveis interações droga

  14. Global patient safety and antiretroviral drug-drug interactions in the resource-limited setting.

    Science.gov (United States)

    Seden, Kay; Khoo, Saye H; Back, David; Byakika-Kibwika, Pauline; Lamorde, Mohammed; Ryan, Mairin; Merry, Concepta

    2013-01-01

    Scale-up of HIV treatment services may have contributed to an increase in functional health facilities available in resource-limited settings and an increase in patient use of facilities and retention in care. As more patients are reached with medicines, monitoring patient safety is increasingly important. Limited data from resource-limited settings suggest that medication error and antiretroviral drug-drug interactions may pose a significant risk to patient safety. Commonly cited causes of medication error in the developed world include the speed and complexity of the medication use cycle combined with inadequate systems and processes. In resource-limited settings, specific factors may contribute, such as inadequate human resources and high disease burden. Management of drug-drug interactions may be complicated by limited access to alternative medicines or laboratory monitoring. Improving patient safety by addressing the issue of antiretroviral drug-drug interactions has the potential not just to improve healthcare for individuals, but also to strengthen health systems and improve vital communication among healthcare providers and with regulatory agencies.

  15. Detection of counterfeit antiviral drug Heptodin and classification of counterfeits using isotope amount ratio measurements by multicollector inductively coupled plasma mass spectrometry (MC-ICPMS) and isotope ratio mass spectrometry (IRMS).

    Science.gov (United States)

    Santamaria-Fernandez, Rebeca; Hearn, Ruth; Wolff, Jean-Claude

    2009-06-01

    Isotope ratio mass spectrometry (IRMS) and multicollector inductively coupled plasma mass spectrometry (MC-ICP-MS) are highly important techniques that can provide forensic evidence that otherwise would not be available. MC-ICP-MS has proved to be a very powerful tool for measuring high precision and accuracy isotope amount ratios. In this work, the potential of combining isotope amount ratio measurements performed by MC-ICP-MS and IRMS for the detection of counterfeit pharmaceutical tablets has been investigated. An extensive study for the antiviral drug Heptodin has been performed for several isotopic ratios combining MC-ICP-MS and an elemental analyser EA-IRMS for stable isotope amount ratio measurements. The study has been carried out for 139 batches of the antiviral drug and analyses have been performed for C, S, N and Mg isotope ratios. Authenticity ranges have been obtained for each isotopic system and combined to generate a unique multi-isotopic pattern only present in the genuine tablets. Counterfeit tablets have then been identified as those tablets with an isotopic fingerprint outside the genuine isotopic range. The combination of those two techniques has therefore great potential for pharmaceutical counterfeit detection. A much greater power of discrimination is obtained when at least three isotopic systems are combined. The data from these studies could be presented as evidence in court and therefore methods need to be validated to support their credibility. It is also crucial to be able to produce uncertainty values associated to the isotope amount ratio measurements so that significant differences can be identified and the genuineness of a sample can be assessed.

  16. Low-abundance HIV drug-resistant viral variants in treatment-experienced persons correlate with historical antiretroviral use.

    Science.gov (United States)

    Le, Thuy; Chiarella, Jennifer; Simen, Birgitte B; Hanczaruk, Bozena; Egholm, Michael; Landry, Marie L; Dieckhaus, Kevin; Rosen, Marc I; Kozal, Michael J

    2009-06-29

    It is largely unknown how frequently low-abundance HIV drug-resistant variants at levels under limit of detection of conventional genotyping (<20% of quasi-species) are present in antiretroviral-experienced persons experiencing virologic failure. Further, the clinical implications of low-abundance drug-resistant variants at time of virologic failure are unknown. Plasma samples from 22 antiretroviral-experienced subjects collected at time of virologic failure (viral load 1380 to 304,000 copies/mL) were obtained from a specimen bank (from 2004-2007). The prevalence and profile of drug-resistant mutations were determined using Sanger sequencing and ultra-deep pyrosequencing. Genotypes were interpreted using Stanford HIV database algorithm. Antiretroviral treatment histories were obtained by chart review and correlated with drug-resistant mutations. Low-abundance drug-resistant mutations were detected in all 22 subjects by deep sequencing and only in 3 subjects by Sanger sequencing. In total they accounted for 90 of 247 mutations (36%) detected by deep sequencing; the majority of these (95%) were not detected by standard genotyping. A mean of 4 additional mutations per subject were detected by deep sequencing (p<0.0001, 95%CI: 2.85-5.53). The additional low-abundance drug-resistant mutations increased a subject's genotypic resistance to one or more antiretrovirals in 17 of 22 subjects (77%). When correlated with subjects' antiretroviral treatment histories, the additional low-abundance drug-resistant mutations correlated with the failing antiretroviral drugs in 21% subjects and correlated with historical antiretroviral use in 79% subjects (OR, 13.73; 95% CI, 2.5-74.3, p = 0.0016). Low-abundance HIV drug-resistant mutations in antiretroviral-experienced subjects at time of virologic failure can increase a subject's overall burden of resistance, yet commonly go unrecognized by conventional genotyping. The majority of unrecognized resistant mutations correlate with

  17. Low-abundance HIV drug-resistant viral variants in treatment-experienced persons correlate with historical antiretroviral use.

    Directory of Open Access Journals (Sweden)

    Thuy Le

    Full Text Available BACKGROUND: It is largely unknown how frequently low-abundance HIV drug-resistant variants at levels under limit of detection of conventional genotyping (<20% of quasi-species are present in antiretroviral-experienced persons experiencing virologic failure. Further, the clinical implications of low-abundance drug-resistant variants at time of virologic failure are unknown. METHODOLOGY/PRINCIPAL FINDINGS: Plasma samples from 22 antiretroviral-experienced subjects collected at time of virologic failure (viral load 1380 to 304,000 copies/mL were obtained from a specimen bank (from 2004-2007. The prevalence and profile of drug-resistant mutations were determined using Sanger sequencing and ultra-deep pyrosequencing. Genotypes were interpreted using Stanford HIV database algorithm. Antiretroviral treatment histories were obtained by chart review and correlated with drug-resistant mutations. Low-abundance drug-resistant mutations were detected in all 22 subjects by deep sequencing and only in 3 subjects by Sanger sequencing. In total they accounted for 90 of 247 mutations (36% detected by deep sequencing; the majority of these (95% were not detected by standard genotyping. A mean of 4 additional mutations per subject were detected by deep sequencing (p<0.0001, 95%CI: 2.85-5.53. The additional low-abundance drug-resistant mutations increased a subject's genotypic resistance to one or more antiretrovirals in 17 of 22 subjects (77%. When correlated with subjects' antiretroviral treatment histories, the additional low-abundance drug-resistant mutations correlated with the failing antiretroviral drugs in 21% subjects and correlated with historical antiretroviral use in 79% subjects (OR, 13.73; 95% CI, 2.5-74.3, p = 0.0016. CONCLUSIONS/SIGNIFICANCE: Low-abundance HIV drug-resistant mutations in antiretroviral-experienced subjects at time of virologic failure can increase a subject's overall burden of resistance, yet commonly go unrecognized by conventional

  18. Hidden costs of antiretroviral treatment: the public health efficiency of drug packaging.

    Science.gov (United States)

    Andreu-Crespo, Àngels; Llibre, Josep M; Cardona-Peitx, Glòria; Sala-Piñol, Ferran; Clotet, Bonaventura; Bonafont-Pujol, Xavier

    2015-01-01

    While the overall percentage of unused antiretroviral medicines returned to the hospital pharmacy is low, their cost is quite high. Adverse events, treatment failure, pharmacokinetic interactions, pregnancy, or treatment simplification are common reasons for unplanned treatment changes. Socially inefficient antiretroviral packages prevent the reuse of drugs returned to the hospital pharmacy. We defined antiretroviral package categories based on the excellence of drug packaging and analyzed the number of pills and costs of drugs returned during a period of 1 year in a hospital-based HIV unit attending to 2,413 treated individuals. A total of 6,090 pills (34% of all returned antiretrovirals) - with a cost of 47,139.91 € - would be totally lost, mainly due to being packed up in the lowest efficiency packages. Newer treatments are packaged in low-excellence categories of packages, thus favoring the maintenance of these hidden costs in the near future. Therefore, costs of this low-efficiency drug packaging, where medication packages are started but not completed, in high-cost medications are substantial and should be properly addressed. Any improvement in the packaging by the manufacturer, and favoring the choice of drugs supplied through efficient packages (when efficacy, toxicity, and convenience are similar), should minimize the treatment expenditures paid by national health budgets.

  19. Los medicamentos falsificados en Perú Counterfeit pharmaceuticals in Peru

    Directory of Open Access Journals (Sweden)

    Luis E. Moreno Exebio

    2010-02-01

    cierta sofisticación en el proceso de falsificación. La falsificación de medicamentos que salvan vidas, como los antimicrobianos, representa un peligro serio de salud pública.OBJECTIVE: To determine the quantity of counterfeit pharmaceutical drugs found by the National Quality Control Center (Centro Nacional de Control de Calidad (CNCC, Instituto Nacional de Salud, Peru during the period from 2005&2008, and the types and properties of these drugs. METHODS: A form was created to amass the relevant data collected directly from CNCC reports. The reports underwent a review and analysis process, and where counterfeiting was confirmed, it was categorized by type into one of four groups. RESULTS: The percentage of counterfeit drugs relative to the total drugs evaluated was: 3.0% in 2005, 5.0% in 2006, 7.3% in 2007, and 9.2% in 2008. The main groups of counterfeit drugs, classified according to the World Health Organization Anatomical Therapeutic Chemical Classification System, were: alimentary tract and metabolism, 34.5% (29.1%&39.8%; antiinfectives for systemic use, 21.1% (16.5%&25.7%; nervous system, 17.1% (12.8%&21.3%; and musculo-skeletal system, 15.4% (11.3%&19.5%. The most common type of forgery occurred in cases where the drug contained the correct amount of active ingredients, but the manufacturer was one other than the one indicated (62.4% of the total counterfeit drugs; and medications that did not contain any active ingredient (22.4%. Of the counterfeit drugs, 61.0% (56.0%&67.0% were national brands and 39.0%, (33.0%&44.0% were imported. The pharmaceutical formulations with the highest rate of forgery were tablets, 66.0% (60.0%&71.0%; injectables, 19.0% (14.0%&23.0%; and capsules 7.0% (4.0%&10.0%. CONCLUSIONS: From 2005&2008, drug counterfeiting had an average annual variation of 45%. Drug counterfeiting was shown to be most prevalent among national brands& as opposed to imported medications&although the types and formulations of the fake drugs attest to a

  20. Explaining Counterfeit Alcohol Purchases in Russia.

    Science.gov (United States)

    Kotelnikova, Zoya

    2017-04-01

    Alcohol is a common target of counterfeiting in Russia. Counterfeit alcohol is defined here as the manufacture, distribution, unauthorized placement (forgery) of protected commodity trademarks, and infringement of the exclusive rights of the registered trademark holders of alcoholic beverages. It is often argued that the expansion of the counterfeit product market is due to the steady demand of economically disadvantaged people for low-priced goods. The situation becomes more complicated once deceptive and nondeceptive forms of counterfeiting are taken into account. This study aimed to identify markers of risky behavior associated with the purchase of counterfeit alcohol in Russia. The analysis relied on consumer self-reports of alcohol use and purchase collected nationwide by the Russia Longitudinal Monitoring Survey (RLMS-HSE) in 2012 to 2014. I used a generalized linear mixed-model logistic regression to identify predictors of risky behavior by consumers who purchased counterfeit alcohol, either knowingly or unknowingly, during the 30 days preceding the survey. Purchases of counterfeit alcohol declined slightly from 2012 to 2014, mainly due to a decrease in consumers mistakenly purchasing counterfeit products. Predictors of counterfeit alcohol purchases differed between consumers who knowingly and unknowingly purchased counterfeit products. Nondeceptive purchase of counterfeit alcohol was related primarily to an indifference to alcohol brands. Consumers with social networks that include drinkers of nonbeverage alcohol and producers of homemade alcohol were highly likely to consume counterfeit alcohol deliberately. Problem drinking was significantly associated with a higher risk of both deceptive and nondeceptive purchases of counterfeit alcohol. Poverty largely contributed to nondeceptive counterfeiting. The literature has overestimated the impact of low prices on counterfeit alcohol consumption. Problem drinking and membership in social networks of consumers

  1. Falsificação de medicamentos no Brasil Falsificación de medicamentos en Brasil Counterfeiting of drugs in Brazil

    Directory of Open Access Journals (Sweden)

    Joseane Ames

    2012-02-01

    ,9% y 5,7%, respectivamente. La mayor parte de los medicamentos falsos fue incautada en los estados Paraná, Sao Paulo y Santa Catarina, con incremento superior a 200% en el número de medicamentos inauténticos encaminados a la pericia en el período. Hubo aumento en las incautaciones de medicamentos contrabandeados arrecadados en conjunto con los falsos, 67% de las incautaciones incluyeron al menos un medicamento contrabandeado. CONCLUSIONES: La falsificación de medicamentos es un grave problema de salud pública. La identificación de las clases de medicamentos falsos en Brasil y los principales estados brasileños con esta problemática pueden facilitar acciones futuras de prevención y represión por los órganos brasileños responsables.OBJECTIVE: To identify the main counterfeit drugs seized by the Brazilian Federal Police and the states where seizures have been made. METHODS: A retrospective descriptive study on expert reports produced by criminal investigators of the Federal Police between January 2007 and September 2010, in relation to counterfeit drugs, was carried out. RESULTS: The drugs with greatest numbers of seizures were selective phosphodiesterase-5 inhibitors that are used for treating male erectile dysfunction (Cialis® and Viagra®, mean = 66% , followed by anabolic steroids (Durateston® and Hemogenin®: 8.9% and 5.7%, respectively. The greatest proportions of the counterfeit drugs were seized in the states of Paraná, Santa Catarina (both Southeastern Brazil and São Paulo (Southeastern, and the number of non-authentic drugs sent for investigation increased by more than 200% over the study period. There were increases in seizures of smuggled drugs found together with counterfeit drugs: 67% of the seizures included at least one smuggled drug. CONCLUSIONS: Counterfeiting of drugs is a severe public health problem. Identification of the classes of counterfeit drugs present in Brazil and the main Brazilian states with this problem may facilitate

  2. Evaluation of HIV/AIDS patients' knowledge on antiretroviral drugs

    Directory of Open Access Journals (Sweden)

    Regina Flávia de Castro Almeida

    Full Text Available Lack of information on antiretroviral drugs or the misunderstanding of available information can facilitate incorrect use of such drugs. This can result in non-adherence to the prescribed regimen, leading to a great possibility of a therapeutic failure. The aim of this study was to know which information HIV/AIDS patients, who receive their medicines at the pharmacy of a reference hospital in the northeast Brazil, have on the drugs they use, the source of this information and whether there is a need for additional information. A total of 195 HIV/AIDS patients, who were using either zidovudina + lamivudina 300+150mg (AZT+3TC, efavirenz 600mg (EFZ or lopinavir/ritonavir 133.33/33mg (LPV/r, were interviewed. The mean age was 41 years (SD = 9.55 and 70.8% were males. Of the total, 55.4% didn't know the effect of the drug in the organism; 35.9% were unaware of the necessity of taking antiretroviral drugs for the rest of their lives; only 14.4% knew how to proceed when a dosage was missed; 22.1% said they could die and the same number of individuals believed in aggravation of the disease in case of treatment interruption. The majority, 68.2%, considered it very necessary to receive drug information. The results show that there is an apparent lack of general information among users of antiretroviral drugs, and at the same time a need for it. It is necessary that all professionals involved in the health care of the patients agree that an efficient supply of information on prescribed drugs is an ethical component of the treatment that favors and fosters its adherence.

  3. Counterfeit integrated circuits detection and avoidance

    CERN Document Server

    Tehranipoor, Mark (Mohammad); Forte, Domenic

    2015-01-01

    This timely and exhaustive study offers a much-needed examination of the scope and consequences of the electronic counterfeit trade.  The authors describe a variety of shortcomings and vulnerabilities in the electronic component supply chain, which can result in counterfeit integrated circuits (ICs).  Not only does this book provide an assessment of the current counterfeiting problems facing both the public and private sectors, it also offers practical, real-world solutions for combatting this substantial threat.   ·      Helps beginners and practitioners in the field by providing a comprehensive background on the counterfeiting problem; ·      Presents innovative taxonomies for counterfeit types, test methods, and counterfeit defects, which allows for a detailed analysis of counterfeiting and its mitigation; ·      Provides step-by-step solutions for detecting different types of counterfeit ICs; ·      Offers pragmatic and practice-oriented, realistic solutions to counterfeit IC d...

  4. Chromatographic determination of clopidogrel bisulfate; detection and quantification of counterfeit Plavix® tablets

    Directory of Open Access Journals (Sweden)

    Mona E. ElTantawy

    2014-06-01

    Full Text Available Counterfeiting of pharmaceutical products is a global problem. Upon using quality-ensuring methods of international pharmacopoeias, additional impurities and the low content of the active pharmaceutical ingredients were detected. In this paper, two chromatographic HPLC and TLC-densitometric methods were proposed as fast and reliable methods for detection and quantitation of counterfeit Plavix® tablets. These tablets were chemically counterfeited by aspirin, its degradate salicylic acid and metronidazole which were separated, besides the active ingredient clopidogrel bisulfate, by the proposed methods. Also, counterfeit was in packaging, strips and tablets’ color and these could be seen by visual inspection compared to original drug. The proposed methods can easily differentiate genuine from counterfeited tablets without need of prior separation. The proposed methods were validated according to ICH guidelines and applied to eleven batches, also were compared statistically with the reported one.

  5. Progress in counterfeit deterrence: the contribution of information exchange

    Science.gov (United States)

    Lancaster, Ian M.; Kontnik, Lewis T.

    1996-03-01

    In this paper we establish the need for communication between organizations involved in the fight against counterfeiting crime. We also examine the paradox in providing information that could serve the criminal as well as those attempting to protect themselves from criminal activity. Counterfeiting is estimated to account for over 5% of world trade. It is a global operation with no respect for international borders. It is increasingly sophisticated and increasingly the province of organized crime, which applies the techniques developed for drug distribution to the production and distribution of counterfeit articles. To fight this crime there is an increasing plethora of authenticating features and technologies available. Many companies do not recognize the problem and the number of anticounterfeit technologies can be confusing for potential users. There is therefore a need for information about them, their comparative characteristics, to be easily available. At present there is inadequate communication between those who develop and produce anti-counterfeiting devices and those who use them, notwithstanding the marketing efforts of the former. Communication which stimulates and encourages the spread of information between those engaged in the fight against counterfeit crime can only help in that fight. But what we term 'the communication paradox' requires circumspection and care in the content and the distribution of such information. The communication paradox is that the better the channels of communication, the easier it is for criminals to get hold of that information. The challenge is to institute communications which are effective but restrictive. More communication of information between those engaged in counterfeit deterrence will enhance individual companies' and organizations' anticounterfeit efforts and thus contribute to an overall improvement in the fight against counterfeit crime.

  6. Hidden costs of antiretroviral treatment: the public health efficiency of drug packaging

    Directory of Open Access Journals (Sweden)

    Andreu-Crespo À

    2015-08-01

    Full Text Available Àngels Andreu-Crespo,1,* Josep M Llibre,2,3,* Glòria Cardona-Peitx,1 Ferran Sala-Piñol,1 Bonaventura Clotet,2,4 Xavier Bonafont-Pujol1 1Pharmacy Department, 2HIV Unit and “Lluita contra la SIDA” Foundation, University Hospital Germans Trias i Pujol, Badalona, 3Universitat Autònoma de Barcelona, 4Universitat de Vic-Universitat Central de Catalunya (UVIC-UCC, Vic, Barcelona, Spain *These authors contributed equally to the work Abstract: While the overall percentage of unused antiretroviral medicines returned to the hospital pharmacy is low, their cost is quite high. Adverse events, treatment failure, pharmacokinetic interactions, pregnancy, or treatment simplification are common reasons for unplanned treatment changes. Socially inefficient antiretroviral packages prevent the reuse of drugs returned to the hospital pharmacy. We defined antiretroviral package categories based on the excellence of drug packaging and analyzed the number of pills and costs of drugs returned during a period of 1 year in a hospital-based HIV unit attending to 2,413 treated individuals. A total of 6,090 pills (34% of all returned antiretrovirals – with a cost of 47,139.91€ – would be totally lost, mainly due to being packed up in the lowest efficiency packages. Newer treatments are packaged in low-excellence categories of packages, thus favoring the maintenance of these hidden costs in the near future. Therefore, costs of this low-efficiency drug packaging, where medication packages are started but not completed, in high-cost medications are substantial and should be properly addressed. Any improvement in the packaging by the manufacturer, and favoring the choice of drugs supplied through efficient packages (when efficacy, toxicity, and convenience are similar, should minimize the treatment expenditures paid by national health budgets. Keywords: antiretroviral treatment, cost efficacy, drug packaging, treatment change

  7. Improving global health governance to combat counterfeit medicines: a proposal for a UNODC-WHO-Interpol trilateral mechanism.

    Science.gov (United States)

    Mackey, Tim K; Liang, Bryan A

    2013-10-31

    Perhaps no greater challenge exists for public health, patient safety, and shared global health security, than fake/falsified/fraudulent, poor quality unregulated drugs, also commonly known as "counterfeit medicines", now endemic in the global drug supply chain. Counterfeit medicines are prevalent everywhere, from traditional healthcare settings to unregulated sectors, including the Internet. These dangerous medicines are expanding in both therapeutic and geographic scope, threatening patient lives, leading to antimicrobial resistance, and profiting criminal actors. Despite clear global public health threats, surveillance for counterfeit medicines remains extremely limited, with available data pointing to an increasing global criminal trade that has yet to be addressed appropriately. Efforts by a variety of public and private sector entities, national governments, and international organizations have made inroads in combating this illicit trade, but are stymied by ineffectual governance and divergent interests. Specifically, recent efforts by the World Health Organization, the primary international public health agency, have failed to adequately incorporate the broad array of stakeholders necessary to combat the problem. This has left the task of combating counterfeit medicines to other organizations such as UN Office of Drugs and Crime and Interpol in order to fill this policy gap. To address the current failure of the international community to mobilize against the worldwide counterfeit medicines threat, we recommend the establishment of an enhanced global health governance trilateral mechanism between WHO, UNODC, and Interpol to leverage the respective strengths and resources of these organizations. This would allow these critical organizations, already engaged in the fight against counterfeit medicines, to focus on and coordinate their respective domains of transnational crime prevention, public health, and law enforcement field operations. Specifically, by

  8. Access to antiretroviral drugs and AIDS management in Senegal.

    Science.gov (United States)

    Desclaux, Alice; Ciss, Mounirou; Taverne, Bernard; Sow, Papa S; Egrot, Marc; Faye, Mame A; Lanièce, Isabelle; Sylla, Omar; Delaporte, Eric; Ndoye, Ibrahima

    2003-07-01

    Description and analysis of the Senegalese Antiretroviral Drug Access Initiative (ISAARV), the first governmental highly active antiretroviral therapy (HAART) treatment programme in Africa, launched in 1998. ISAARV was initially an experimental project designed to evaluate the feasibility, efficacy and acceptability of HAART in an African context. It was based on four principles: collective definition of the strategy, with involvement of the health professionals who would be called on to execute the programme; matching the objectives to available means (gradual enrollment according to drug availability); monitoring by several research programmes; and ongoing adaptation of treatment and follow-up according to the latest international recommendations. Persons qualifying for antiretroviral (ARV) therapy are selected on the basis of immunological and clinical criteria, regardless of economic and social considerations. A system of subsidies was created to favor access to ARV. Following the ARV price reductions that occurred in November 2000, 100% subsidies were created for the poorest participants. Optimal adherence was ensured by monthly follow-up by pharmacists and support groups held by social workers and patient associations. The chosen supply and distribution system allowed drug dispensing to be strictly controlled. The ISAARV programme demonstrates that HAART can be successfully prescribed in Africa. This experience has served as the basis for the creation of a national treatment programme in Senegal planned to treat 7000 patients by 2006.

  9. Quality of Life and Adherence to Antiretroviral Drugs

    African Journals Online (AJOL)

    Sitwala

    Department of Nursing Sciences, School of Medicine, University of Zambia, Lusaka, Zambia. ABSTRACT ... it is individually, socially and culturally determined. .... concept that is a semantic representation which .... antiretroviral drugs enhances quality of life and is clearly in keeping with the philosophy of palliative. 19 care .

  10. Contra Davidson on Counterfeiting, Round Two

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    Walter E. Block

    2013-12-01

    Full Text Available Libertarians and non libertarians alike agree that counterfeiting legitimate money owned by innocent people is illicit.  But what about counterfeiting counterfeit money owned by the guiltless? Davidson and I, both libertarians, take the position that this would be a rights violation; that this would violate the rights of innocent owners of currency, who would be victimized by such fraudulent behavior of counterfeiters, even those who limit themselves to counterfeiting counterfeit funds. But what about counterfeiting counterfeit money owned by those who are guilty of crimes? Davidson (2013 opines, in effect, that there are no such people. The counterfeiter of counterfeit money is thus himself a criminal, she avers. I argue, very much to the contrary, that the relevant population consists mostly of guilty people, and thus they are not in a logical position to object to what would otherwise be considered victimization. As for the few innocents among them, they demonstrate their innocence to a large degree by not objecting to the counterfeiting of counterfeit money. If they do object, and take actions to prevent this practice, they act in a manner incompatible with the libertarian non aggression principle (NAP and thus enter the ranks of the guilty. I find Davidson’s (2013 economic analysis impeccable; her understanding of libertarianism highly problematic.In the interests of full disclosure, I should make it clear that the present paper contains the radical suggestion that we should do away with our established monetary- and financial system. If need be, and this is by no means my first choice, we are entitled to do so by means of massive counterfeiting of established currencies (which is justified by deontological considerations and libertarian principles. Of course, this is illegal in extant nations, and I would not want to be imprisoned for committing a crime. So, for purposes of our discussion, we will be considering only the imaginary

  11. RFID in the pharmaceutical industry: addressing counterfeits with technology.

    Science.gov (United States)

    Taylor, Douglas

    2014-11-01

    The use of Radio Frequency Identification (RFID) in the pharmaceutical industry has grown in recent years. The technology has matured from its specialized tracking and retail uses to a systemic part of supply chain management in international pharmaceutical production and distribution. Counterfeit drugs, however, remain a significant challenge for governments, pharmaceutical companies, clinicians, and patients and the use of RFID to track these compounds represents an opportunity for development. This paper discusses the medical, technological, and economic factors that support widespread adoption of RFID technology in the pharmaceutical industry in an effort to prevent counterfeit medicines from harming patients and brand equity.

  12. Pharmacoepidemiology of antiretroviral drugs in a teaching hospital ...

    African Journals Online (AJOL)

    Objective: Prescribing, adherence, and adverse drug events to HAART in a large antiretroviral programme in Lagos was evaluated. Design: A retrospective 5 year open cohort study. Setting: The AIDS Prevention Initiative in Nigeria (APIN) clinic at LUTH is one of the United States Presidential Emergency Plan for AIDS ...

  13. 'Counterfeit deviance' revisited.

    Science.gov (United States)

    Griffiths, Dorothy; Hingsburger, Dave; Hoath, Jordan; Ioannou, Stephanie

    2013-09-01

    The field has seen a renewed interest in exploring the theory of 'counterfeit deviance' for persons with intellectual disability who sexually offend. The term was first presented in 1991 by Hingsburger, Griffiths and Quinsey as a means to differentiate in clinical assessment a subgroup of persons with intellectual disability whose behaviours appeared like paraphilia but served a function that was not related to paraphilia sexual urges or fantasies. Case observations were put forward to provide differential diagnosis of paraphilia in persons with intellectual disabilities compared to those with counterfeit deviance. The brief paper was published in a journal that is no longer available and as such much of what is currently written on the topic is based on secondary sources. The current paper presents a theoretical piece to revisit the original counterfeit deviance theory to clarify the myths and misconceptions that have arisen and evaluate the theory based on additional research and clinical findings. The authors also propose areas where there may be a basis for expansion of the theory. The theory of counterfeit deviance still has relevance as a consideration for clinicians when assessing the nature of a sexual offence committed by a person with an intellectual disability. Clinical differentiation of paraphilia from counterfeit deviance provides a foundation for intervention that is designed to specifically treat the underlying factors that contributed to the offence for a given individual. Counterfeit deviance is a concept that continues to provide areas for consideration for clinicians regarding the assessment and treatment of an individual with an intellectual disability who has sexually offended. It is not and never was an explanation for all sexually offending behavior among persons with intellectual disabilities. © 2013 John Wiley & Sons Ltd.

  14. Combating the counterfeits with web portal technology

    Science.gov (United States)

    Ting, S. L.; Ip, W. H.

    2015-10-01

    Due to the globalisation of counterfeiting activities, the penetration of fake products in open market is growing. So far, the technologies to combat counterfeiting are mostly applied to high-value products (e.g. premium wine and branded handbags); however, in the medium- and low-value products' perspective, there is no secure way for consumers to identify whether the purchased items are genuine or not. To address the counterfeiting problems effectively, a platform for identifying authenticated products and promoting anti-counterfeit activities is very important. The aim of this paper is to design and develop an anti-counterfeit platform which includes two functions: providing customers a secure network to ascertain the genuineness of their purchased product and increasing public awareness of the current counterfeit problems and updated anti-counterfeit solutions. By combining these two functions, it enables public to fight against fake and beware of counterfeit. Results of adopting portal technology in anti-counterfeiting show high accuracy in product checking and improved creditability. This reveals that the applicability and advantage of the proposed methodology are satisfactory.

  15. Business strategies in the counterfeit market

    OpenAIRE

    Staake, Thorsten; Thiesse, Frederic; Fleisch, Elgar

    2012-01-01

    Counterfeit trade is amulti-billion dollar industry affecting anever-wider range of goods andmarkets. Despite the diversity of counterfeit products in terms of complexity, manufacturing techniques, investments in production facilities, potential dangers or value for the users, and degrees of conflict for the counterfeit producers with the local authorities, current academic literature still refers to counterfeit producers as one homogeneous group. Against this background, the present study in...

  16. Interactions between recreational drugs and antiretroviral agents.

    Science.gov (United States)

    Antoniou, Tony; Tseng, Alice Lin-In

    2002-10-01

    To summarize existing data regarding potential interactions between recreational drugs and drugs commonly used in the management of HIV-positive patients. Information was obtained via a MEDLINE search (1966-August 2002) using the MeSH headings human immunodeficiency virus, drug interactions, cytochrome P450, medication names commonly prescribed for the management of HIV and related opportunistic infections, and names of commonly used recreational drugs. Abstracts of national and international conferences, review articles, textbooks, and references of all articles were also reviewed. Literature on pharmacokinetic interactions was considered for inclusion. Pertinent information was selected and summarized for discussion. In the absence of specific data, prediction of potential clinically significant interactions was based on pharmacokinetic and pharmacodynamic properties. All protease inhibitors (PIs) and nonnucleoside reverse transcriptase inhibitors are substrates and potent inhibitors or inducers of the cytochrome P450 system. Many classes of recreational drugs, including benzodiazepines, amphetamines, and opioids, are also metabolized by the liver and can potentially interact with antiretrovirals. Controlled interaction studies are often not available, but clinically significant interactions have been observed in a number of case reports. Overdoses secondary to interactions between the "rave" drugs methylenedioxymethamphetamine (MDMA) or gamma-hydroxybutyrate (GHB) and PIs have been reported. PIs, particularly ritonavir, may also inhibit metabolism of amphetamines, ketamine, lysergic acid diethylmide (LSD), and phencyclidine (PCP). Case series and pharmacokinetic studies suggest that nevirapine and efavirenz induce methadone metabolism, which may lead to symptoms of opiate withdrawal. A similar interaction may exist between methadone and the PIs ritonavir and nelfinavir, although the data are less consistent. Opiate metabolism can be inhibited or induced by

  17. ROLE OF THE INTERNATIONAL ORGANIZATIONS IN PREVENTING THE COUNTERFEIT MEDICINES ENTRY INTO THE WORLD MARKETS.

    Science.gov (United States)

    Stukina, Valeryia; Dohnal, Jiri; Saloun, Jan

    2016-09-01

    30 years have passed since Conference of Experts on the Rational Use of Drugs was held in Nairobi, Kenya, from 25 to 29 November 1985, where the problem of counterfeit medicines was mentioned as the international for the first time. The problem of counterfeit medicines is not only a major threat to public health and national and private economy, but also it is of great interest for key decision-making actors at the international level. The authors analyzed what has been done since that time by international organizations. Combating the counterfeiting of medicines cannot be successfully achieved by the health sector alone - World Health Organization (WHO), - so the efforts of the other United Nations (UN) organizations relevant to counterfeiting were in need and were studied in the article: World Intellectual Property Organization (WIPO), World Trade Organization (WTO), World Customs Organization (WCO), United Nations Office on Drugs and Crime (UNODC), etc. Today WHO is unable to coordinate all their activities, so the few existing proposals for establishing a new mechanism of international cooperation have been examined. Will the MEDICRIME Convention that will enter into force on January 1, 2016 be the start of the new era in the combating with the counterfeit medicines? - the authors offered their vision on the international developments.

  18. The status of HIV-1 resistance to antiretroviral drugs in sub-Saharan Africa

    NARCIS (Netherlands)

    Hamers, Raph L.; Derdelinckx, Inge; van Vugt, Michèle; Stevens, Wendy; Rinke de Wit, Tobias F.; Schuurman, Rob

    2008-01-01

    Access to highly active antiretroviral therapy (HAART) for persons infected with HIV in sub-Saharan Africa has greatly improved over the past few years. However, data on long-term clinical outcomes of Africans receiving HAART, patterns of HIV resistance to antiretroviral drugs and implications of

  19. Vietnamese Women's Struggle to Access Antiretroviral Drugs in a Context of Free Treatment

    DEFF Research Database (Denmark)

    Nguyen, Nam Thi Thu; Rasch, Vibeke; Bygbjerg, Ib Christian

    2013-01-01

    This qualitative study aims to explore how HIV positive women living in a northern province of Vietnam experience seeking antiretroviral (ARV) treatment in the public health system, and how they address obstacles encountered along the way. Despite the fact that antiretroviral drugs were freely pr...

  20. Counterfeiting: Education Influences Ethical Decision Making

    Science.gov (United States)

    Kozar, Joy M.; Marcketti, Sara B.

    2008-01-01

    The purpose of this article is to address the relationship between the purchase of counterfeit apparel goods by college students and their knowledge and concern of counterfeiting. Additionally, students' beliefs regarding the legality of manufacturing, distributing, and purchasing counterfeit goods are examined. This topic is important because…

  1. Spirituality and adherence to antiretroviral drugs among HIV positive ...

    African Journals Online (AJOL)

    Method: It was an observational, longitudinal study in which 215 consenting HIV positive patients aged 18 to 65 years who were on antiretroviral drugs were recruited through systematic random sampling technique. Socio-demographic characteristics, clinical history and physical examination findings were documented for ...

  2. Forensic intelligence for medicine anti-counterfeiting.

    Science.gov (United States)

    Dégardin, Klara; Roggo, Yves; Margot, Pierre

    2015-03-01

    Medicine counterfeiting is a crime that has increased in recent years and now involves the whole world. Health and economic repercussions have led pharmaceutical industries and agencies to develop many measures to protect genuine medicines and differentiate them from counterfeits. Detecting counterfeit is chemically relatively simple for the specialists, but much more information can be gained from the analyses in a forensic intelligence perspective. Analytical data can feed criminal investigation and law enforcement by detecting and understanding the criminal phenomenon. Profiling seizures using chemical and packaging data constitutes a strong way to detect organised production and industrialised forms of criminality, and is the focus of this paper. Thirty-three seizures of a commonly counterfeited type of capsule have been studied. The results of the packaging and chemical analyses were gathered within an organised database. Strong linkage was found between the seizures at the different production steps, indicating the presence of a main counterfeit network dominating the market. The interpretation of the links with circumstantial data provided information about the production and the distribution of counterfeits coming from this network. This forensic intelligence perspective has the potential to be generalised to other types of products. This may be the only reliable approach to help the understanding of the organised crime phenomenon behind counterfeiting and to enable efficient strategic and operational decision making in an attempt to dismantle counterfeit network. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  3. Raman spectroscopy, a non-invasive mesurement technique for the detection of counterfeit medicines

    OpenAIRE

    Marta, Teresa Rita Pitorra

    2016-01-01

    Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2016 Perhaps no greater challenge exists for public health, patient safety, and shared global health security, than fake, falsified, fraudulent or poor quality unregulated medicines - also commonly known as “counterfeit medicines” - now endemic in the global drug supply chain (Tim K Mackey & Liang, 2013). Counterfeit medicines pose a serious risk to public health around the world. It is low- and mi...

  4. [Are there counterfeit medicines in Croatia?].

    Science.gov (United States)

    Tomić, Sinisa; Milcić, Neven; Sokolić, Milenko; Sucić, Anita Filipović; Martinac, Adrijana Ilić

    2010-01-01

    Counterfeit medicines are a growing problem in the world, for their use may endanger patient's health and therefore they pose an enormous public health risk. The manufacture of counterfeit medicines usually involves organised crime groups which place the counterfeit medicines on the market for reasons of profit. Detection and prevention of trade in counterfeit medicines requires close cooperation between medicine regulatory authorities, police, customs, judiciary and pharmaceutical industry. To this day, there have been no recorded cases of counterfeit medicines in the legal supply chain in Croatia. However, medicines without marketing authorisation in Croatia, originating from different countries, could be found on the illegal market. Most frequently, this includes medicines for the treatment of erectile dysfunction such as: sildenafil, tadalafil, vardenafil. In this study, 26 medicines for the treatment of erectile dysfunction, seized in illegal supply chain, were tested. High performance liquid chromatography (HPLC) was used for identification and quantification of active substances in the tested samples. It was determined that 13 out of 26 samples did not comply with declared composition of medicine and quality specification. Furthermore, two samples did not contain declared active substance vardenafil and that may indicate that these medicines are counterfeit.

  5. Directly administered antiretroviral therapy for HIV-infected drug users does not have an impact on antiretroviral resistance: results from a randomized controlled trial.

    Science.gov (United States)

    Maru, Duncan Smith-Rohrberg; Kozal, Michael J; Bruce, R Douglas; Springer, Sandra A; Altice, Frederick L

    2007-12-15

    Directly administered antiretroviral therapy (DAART) is an effective intervention that improves clinical outcomes among HIV-infected drug users. Its effects on antiretroviral drug resistance, however, are unknown. We conducted a community-based, prospective, randomized controlled trial of DAART compared with self-administered therapy (SAT). We performed a modified intention-to-treat analysis among 115 subjects who provided serum samples for HIV genotypic resistance testing at baseline and at follow-up. The main outcomes measures included total genotypic sensitivity score, future drug options, number of new drug resistance mutations (DRMs), and number of new major International AIDS Society (IAS) mutations. The adjusted probability of developing at least 1 new DRM did not differ between the 2 arms (SAT: 0.41 per person-year [PPY], DAART: 0.49 PPY; adjusted relative risk [RR] = 1.04; P = 0.90), nor did the number of new mutations (SAT: 0.76 PPY, DAART: 0.83 PPY; adjusted RR = 0.99; P = 0.99) or the probability of developing new major IAS new drug mutations (SAT: 0.30 PPY, DAART: 0.33 PPY; adjusted RR = 1.12; P = 0.78). On measures of GSS and FDO, the 2 arms also did not differ. In this trial, DAART provided on-treatment virologic benefit for HIV-infected drug users without affecting the rate of development of antiretroviral medication resistance.

  6. In-vitro photo-translocation of antiretroviral drug delivery into TZMbl cells

    CSIR Research Space (South Africa)

    Malabi, Rudzani

    2017-01-01

    Full Text Available . Therapeutic targeting of HIV therefore requires further investigation and current therapies need modification in order to address HIV eradication. This deflects research towards investigating potential novel antiretroviral drug delivery systems. The use...

  7. Drug-drug interactions between anti-retroviral therapies and drugs of abuse in HIV systems.

    Science.gov (United States)

    Kumar, Santosh; Rao, P S S; Earla, Ravindra; Kumar, Anil

    2015-03-01

    Substance abuse is a common problem among HIV-infected individuals. Importantly, addictions as well as moderate use of alcohol, smoking, or other illicit drugs have been identified as major reasons for non-adherence to antiretroviral therapy (ART) among HIV patients. The literature also suggests a decrease in the response to ART among HIV patients who use these substances, leading to failure to achieve optimal virological response and increased disease progression. This review discusses the challenges with adherence to ART as well as observed drug interactions and known toxicities with major drugs of abuse, such as alcohol, smoking, methamphetamine, cocaine, marijuana, and opioids. The lack of adherence and drug interactions potentially lead to decreased efficacy of ART drugs and increased ART, and drugs of abuse-mediated toxicity. As CYP is the common pathway in metabolizing both ART and drugs of abuse, we discuss the possible involvement of CYP pathways in such drug interactions. We acknowledge that further studies focusing on common metabolic pathways involving CYP and advance research in this area would help to potentially develop novel/alternate interventions and drug dose/regimen adjustments to improve medication outcomes in HIV patients who consume drugs of abuse.

  8. Affordable HIV drug-resistance testing for monitoring of antiretroviral therapy in sub-Saharan Africa.

    Science.gov (United States)

    Inzaule, Seth C; Ondoa, Pascale; Peter, Trevor; Mugyenyi, Peter N; Stevens, Wendy S; de Wit, Tobias F Rinke; Hamers, Raph L

    2016-11-01

    Increased provision of antiretroviral therapy in sub-Saharan Africa has led to a growing number of patients with therapy failure and acquired drug-resistant HIV, driving the demand for more costly further lines of antiretroviral therapy. In conjunction with accelerated access to viral load monitoring, feasible and affordable technologies to detect drug-resistant HIV could help maximise the durability and rational use of available drug regimens. Potential low-cost technologies include in-house Sanger and next-generation sequencing in centralised laboratories, and point mutation assays and genotype-free systems that predict response to antiretroviral therapy at point-of-care. Strengthening of centralised high-throughput laboratories, including efficient systems for sample referral and results delivery, will increase economies-of-scale while reducing costs. Access barriers can be mitigated by standardisation of in-house assays into commercial kits, use of polyvalent instruments, and adopting price-reducing strategies. A stepwise rollout approach should improve feasibility, prioritising WHO-recommended population-based surveillance and management of complex patient categories, such as patients failing protease inhibitor-based antiretroviral therapy. Implementation research, adaptations of existing WHO guidance, and political commitment, will be key to support the appropriate investments and policy changes. In this Personal View, we discuss the potential role of HIV drug resistance testing for population-based surveillance and individual patient management in sub-Saharan Africa. We review the strengths and challenges of promising low-cost technologies and how they can be implemented. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Counterfeit detection for new and old currency designs

    Science.gov (United States)

    Hillstrom, Anne P.; Bernstein, Ira H.

    2002-04-01

    To test the effectiveness of counterfeit deterrence features recently introduced in US currency, observers were asked to discriminate genuine from counterfeit bills using a two-alternative forced-choice task. In Experiment 1, observers judged 100s with the new and old designs after receiving training in the deterrence features of each design. The counterfeits were representative of two common print processes: inkjet and offset printing. Judgments were made on whole bills, on individual features with the whole bill unmasked, and on individual features with only that feature visible. In Experiment 2, different observers judged 100s without any training. They then were trained and judged 50s and 20 bills. Taken together, the two experiments indicate that people are good at detecting counterfeits, that inkjet counterfeits are easier to detect than offset counterfeits, and that counterfeits of the newly designed bills are easier to detect than counterfeits of the older series. The design improvement was greatest with 100 bills and, to a lesser extent, 50 bills. Improvement was minimal with 20 bills, very likely because observers were very accurate for both series of 20s. Finally, some deterrence features were more useful than others in aiding discriminations.

  10. Counterfeit analysis strategy illustrated by a case study.

    Science.gov (United States)

    Dégardin, Klara; Roggo, Yves

    2016-01-01

    Medicine counterfeiting is a current problem that the whole pharmaceutical field has to deal with. In 2014, counterfeits entered the legitimate supply chain in Europe. Quick and efficient action had to be taken. The aim of this paper is to explain which analytical strategy was chosen to deal with six of the cases concerned and which criteria have to be considered to provide quick and thorough information about the counterfeits. The evaluation of the packaging was performed in a first step, based on a comparison with genuine samples and evaluation of manipulation signs. Chemical methods were then used, consisting of near infrared and infrared spectroscopy, capillary zone electrophoresis and ultraviolet-visible spectrophotometry, in order to authenticate the samples and provide the chemical composition of the confirmed counterfeits. Among the 20 samples analyzed, 17 were confirmed as counterfeits. The counterfeits were the results of the manipulation of genuine samples, and one contained totally counterfeited parts. Several manipulation signs were asserted, like the addition of glue on the boxes and the vials. Genuine stolen goods had been diluted with water, while for an isolated case, a different active ingredient had been introduced in a vial. The analytical data generated were further investigated from a forensic intelligence perspective. Links could be revealed between the analyzed counterfeits, together with some interesting information about the modus operandi of the counterfeiters. The study was performed on a limited number of cases, and therefore encourages chemical and packaging profiling of counterfeits at a bigger scale. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  11. AVOID BECOMING A VICTIM OF COUNTERFEIT ITEMS

    Energy Technology Data Exchange (ETDEWEB)

    WARRINER RD

    2011-07-13

    In today's globalized economy, we cannot live without imported products. Most people do not realize how thin the safety net of regulation and inspection really is. Less than three percent of imported products receive any form of government inspection prior to sale. Avoid flea markets, street vendors and deep discount stores. The sellers of counterfeit wares know where to market their products. They look for individuals who are hungry for a brand name item but do not want to pay a brand name price for it. The internet provides anonymity to the sellers of counterfeit products. Unlike Europe, U.S. law does not hold internet-marketing organizations, responsible for the quality of the products sold on their websites. These organizations will remove an individual vendor when a sufficient number of complaints are lodged, but they will not take responsibility for the counterfeit products you may have purchased. EBay has a number of counterfeit product guides to help you avoid being a victim of the sellers of these products. Ten percent of all medications taken worldwide are counterfeit. If you do buy medications on-line, be sure that the National Association of Boards of Pharmacy Verified Internet Pharmacy Practice Sites (VIPPS) recommends the pharmacy you choose to use. Inspect all medication purchases and report any change in color, shape, imprinting or odor to your pharmacist. If you take generic medications these attributes may change from one manufacturer to another. Your pharmacist should inform you of any changes when you refill your prescription. If they do not, get clarification prior to taking the medication. Please note that the Federal Drug Administration (FDA) does not regulate supplements. The FDA only steps in when a specific supplement proves to cause physical harm or contains a regulated ingredient. Due to counterfeiting, Underwriters Laboratories (UL) changed their label design three times since 1996. The new gold label should be attached to the cord

  12. Fashion Counterfeiting: Consumer Behavior Issues

    Science.gov (United States)

    Cheek, Wanda K.; Easterling, Cynthia R.

    2008-01-01

    Counterfeiting, which has always been somewhat of a problem in several different industry settings, has recently become an epidemic in the fashion industry. Widespread and seemingly endless counterfeiting of fashion goods is costing the industry millions of dollars in lost profits and tarnishing the image of many luxury brands. This article…

  13. Antiretroviral drug resistance: A guide for the southern African clinician

    African Journals Online (AJOL)

    Both private and public sector see a bewildering clinical array of patients taking failing antiretroviral (ARV) regimens. We intend this article to provide a practical guide to help clinicians understand and manage ARV drug resistance in an African context. ARV resistance is a rapidly evolving field, requiring expertise in dealing ...

  14. A Systematic Review of Antiretroviral Adherence Interventions for HIV-Infected People Who Use Drugs

    OpenAIRE

    CampBinford, Meredith; Kahana, Shoshana Y.; Altice, Frederick L.

    2012-01-01

    HIV-infected persons who use drugs (PWUDs) are particularly vulnerable for suboptimal combination antiretroviral therapy (cART) adherence. A systematic review of interventions to improve cART adherence and virologic outcomes among HIV-infected PWUDs was conducted. Among the 45 eligible studies, randomized controlled trials suggested directly administered antiretroviral therapy, medication-assisted therapy (MAT), contingency management, and multi-component, nurse-delivered interventions provid...

  15. Counterfeit Electronics Detection Using Image Processing and Machine Learning

    Science.gov (United States)

    Asadizanjani, Navid; Tehranipoor, Mark; Forte, Domenic

    2017-01-01

    Counterfeiting is an increasing concern for businesses and governments as greater numbers of counterfeit integrated circuits (IC) infiltrate the global market. There is an ongoing effort in experimental and national labs inside the United States to detect and prevent such counterfeits in the most efficient time period. However, there is still a missing piece to automatically detect and properly keep record of detected counterfeit ICs. Here, we introduce a web application database that allows users to share previous examples of counterfeits through an online database and to obtain statistics regarding the prevalence of known defects. We also investigate automated techniques based on image processing and machine learning to detect different physical defects and to determine whether or not an IC is counterfeit.

  16. Counterfeit Electronics Detection Using Image Processing and Machine Learning

    International Nuclear Information System (INIS)

    Asadizanjani, Navid; Tehranipoor, Mark; Forte, Domenic

    2017-01-01

    Counterfeiting is an increasing concern for businesses and governments as greater numbers of counterfeit integrated circuits (IC) infiltrate the global market. There is an ongoing effort in experimental and national labs inside the United States to detect and prevent such counterfeits in the most efficient time period. However, there is still a missing piece to automatically detect and properly keep record of detected counterfeit ICs. Here, we introduce a web application database that allows users to share previous examples of counterfeits through an online database and to obtain statistics regarding the prevalence of known defects. We also investigate automated techniques based on image processing and machine learning to detect different physical defects and to determine whether or not an IC is counterfeit. (paper)

  17. Recent Trends in Counterfeiting

    OpenAIRE

    Arianna Cowling

    2011-01-01

    Under the Reserve Bank Act 1959, the Reserve Bank has sole authority to issue banknotes in Australia. As such, a key responsibility of the Reserve Bank is to maintain public confidence in banknotes, so that they remain an effective payment mechanism and a secure store of wealth. This article examines how counterfeiting can impact on this confidence, and counterfeiting trends in Australia and overseas. The article also discusses the strategies the Reserve Bank employs to minimise the risks of ...

  18. Conspicuous consumption, luxury products and counterfeit market in the UK

    Directory of Open Access Journals (Sweden)

    Trang Huyen My Pham

    2016-05-01

    Full Text Available The fast growth of fashion brands and the popularity of counterfeit goods has posed certain challenges to the existing and new luxury fashion brand players. This study elaborates on the factors driving the market for counterfeit products in the UK. The data collected by means of survey questionnaires from 306 respondents and empirical techniques including descriptive and inferential statistics (correlation and multiple regression analysis, have shown that the consumers have a negative attitude towards counterfeit luxury products. However, they showed fewer tendencies to seek for a brand whose counterfeit cannot easily be found and preferred to buy a genuine rather than a counterfeit. In terms of frequency of purchase, reversion to counterfeit has negative impact, unlike the tendency to seek a brand whose counterfeit is hard to find. The overall results show that the attitude and acceptance of counterfeit do not greatly prevail in the market. However, about 27% of respondents demonstrated either a positive or a neutral tendency towards counterfeit products, which could have serious implications for the luxury goods market.

  19. Impact of Active Drug Use on Antiretroviral Therapy Adherence and Viral Suppression in HIV-infected Drug Users

    OpenAIRE

    Arnsten, Julia H; Demas, Penelope A; Grant, Richard W; Gourevitch, Marc N; Farzadegan, Homayoon; Howard, Andrea A; Schoenbaum, Ellie E

    2002-01-01

    Despite a burgeoning literature on adherence to HIV therapies, few studies have examined the impact of ongoing drug use on adherence and viral suppression, and none of these have utilized electronic monitors to quantify adherence among drug users. We used 262 electronic monitors to measure adherence with all antiretrovirals in 85 HIV-infected current and former drug users, and found that active cocaine use, female gender, not receiving Social Security benefits, not being married, screening po...

  20. High prevalence of antiretroviral drug resistance among HIV-1-untreated patients in Guinea-Conakry and in Niger.

    Science.gov (United States)

    Charpentier, Charlotte; Bellecave, Pantxika; Cisse, Mohamed; Mamadou, Saidou; Diakite, Mandiou; Peytavin, Gilles; Tchiombiano, Stéphanie; Teisseire, Pierre; Pizarro, Louis; Storto, Alexandre; Brun-Vézinet, Françoise; Katlama, Christine; Calvez, Vincent; Marcelin, Anne-Geneviève; Masquelier, Bernard; Descamps, Diane

    2011-01-01

    The aim of the study was to assess the prevalence of antiretroviral drug resistance mutations in HIV-1 from recently diagnosed and untreated patients living in Conakry, Guinea-Conakry and in Niamey, Niger. The study was performed in two countries of Western Africa - Guinea-Conakry and Niger - using the same survey method in both sites. All newly HIV-1 diagnosed patients, naive of antiretroviral drugs, were consecutively included during September 2009 in each of the two sites. Protease and reverse transcriptase sequencing was performed using the ANRS procedures. Drug resistance mutations were identified according to the 2009 update surveillance drug resistance mutations. In Conakry, 99 patients were included, most of whom (89%) were infected with CRF02_AG recombinant virus. Resistance analysis among the 93 samples showed that ≥1 drug resistance mutation was observed in 8 samples, leading to a prevalence of primary resistance of 8.6% (95% CI 2.91-14.29%). In Niamey, 96 patients were included; a high diversity in HIV-1 subtypes was observed with 47 (51%) patients infected with CRF02_AG. Resistance analysis performed among the 92 samples with successful genotypic resistance test showed that ≥1 drug resistance mutation was observed in 6 samples, leading to a prevalence of primary resistance of 6.5% (95% CI 1.50-11.50%). We reported the first antiretroviral drug resistance survey studies in antiretroviral-naive patients living in Guinea-Conakry and in Niger. The prevalence of resistance was between 6% and 9% in both sites, which is higher than most of the other countries from Western Africa region.

  1. Polymeric nanoparticles affect the intracellular delivery, antiretroviral activity and cytotoxicity of the microbicide drug candidate dapivirine.

    Science.gov (United States)

    das Neves, José; Michiels, Johan; Ariën, Kevin K; Vanham, Guido; Amiji, Mansoor; Bahia, Maria Fernanda; Sarmento, Bruno

    2012-06-01

    To assess the intracellular delivery, antiretroviral activity and cytotoxicity of poly(ε-caprolactone) (PCL) nanoparticles containing the antiretroviral drug dapivirine. Dapivirine-loaded nanoparticles with different surface properties were produced using three surface modifiers: poloxamer 338 NF (PEO), sodium lauryl sulfate (SLS) and cetyl trimethylammonium bromide (CTAB). The ability of nanoparticles to promote intracellular drug delivery was assessed in different cell types relevant for vaginal HIV transmission/microbicide development. Also, antiretroviral activity of nanoparticles was determined in different cell models, as well as their cytotoxicity. Dapivirine-loaded nanoparticles were readily taken up by different cells, with particular kinetics depending on the cell type and nanoparticles, resulting in enhanced intracellular drug delivery in phagocytic cells. Different nanoparticles showed similar or improved antiviral activity compared to free drug. There was a correlation between increased antiviral activity and increased intracellular drug delivery, particularly when cell models were submitted to a single initial short-course treatment. PEO-PCL and SLS-PCL nanoparticles consistently showed higher selectivity index values than free drug, contrasting with high cytotoxicity of CTAB-PCL. These results provide evidence on the potential of PCL nanoparticles to affect in vitro toxicity and activity of dapivirine, depending on surface engineering. Thus, this formulation approach may be a promising strategy for the development of next generation microbicides.

  2. Palatability, adherence and prescribing patterns of antiretroviral drugs for children with human immunodeficiency virus infection in Canada.

    Science.gov (United States)

    Lin, Daren; Seabrook, Jamie A; Matsui, Doreen M; King, Susan M; Rieder, Michael J; Finkelstein, Yaron

    2011-12-01

    To assess the impact of perceived palatability of antiretroviral drugs on adherence to therapy of children infected by human immunodeficiency virus and on prescribing patterns by their caring physicians. Two arms--retrospective chart review and a cross-sectional survey. Tertiary-care pediatric human immunodeficiency virus clinic during a 17-year period. Children with human immunodeficiency virus infection and physicians actively caring for children with human immunodeficiency virus infection in seven provinces in Canada were surveyed regarding their perception of the palatability of 8-liquid and 15 non-liquid antiretroviral medications and its effect on drug selection. Effect of taste preferences of antiretroviral drugs on adherence to treatment by infected children and on drug selection by their caring physicians. Forty of 119 children (34%) refused at least once to an antiretroviral medication. In 5%, treatment was discontinued because of poor palatability. Ritonavir was the least palatable drug (50% of children; p = 0.01). Ritonavir use (OR 4.80 [95%CI 1.34-17.20]) and male gender (OR 7.25 [95%CI 2.30-22.90]) were independent predictors of drug discontinuation because of poor taste. Physicians also perceived liquid ritonavir as the least palatable (p = 0.01) and the most likely to be discontinued (p = 0.01). However, they commonly prescribed it as first-line therapy (p = 0.06). A third of children infected with human immunodeficiency virus fail to adhere to their treatment because of poor drug taste. Physicians are aware of that, but this does not prevent them from selecting the least palatable drugs as first-line therapy. Copyright © 2011 John Wiley & Sons, Ltd.

  3. Astrocyte Senescence and Metabolic Changes in Response to HIV Antiretroviral Therapy Drugs

    Directory of Open Access Journals (Sweden)

    Justin Cohen

    2017-08-01

    Full Text Available With the advent of highly active antiretroviral therapy (HAART survival rates among patients infected by HIV have increased. However, even though survival has increased HIV-associated neurocognitive disorders (HAND still persist, suggesting that HAART-drugs may play a role in the neurocognitive impairment observed in HIV-infected patients. Given previous data demonstrating that astrocyte senescence plays a role in neurocognitive disorders such as Alzheimer’s disease (AD, we examined the role of HAART on markers of senescence in primary cultures of human astrocytes (HAs. Our results indicate HAART treatment induces cell cycle arrest, senescence-associated beta-galactosidase, and the cell cycle inhibitor p21. Highly active antiretroviral therapy treatment is also associated with the induction of reactive oxygen species and upregulation of mitochondrial oxygen consumption. These changes in mitochondria correlate with increased glycolysis in HAART drug treated astrocytes. Taken together these results indicate that HAART drugs induce the senescence program in HAs, which is associated with oxidative and metabolic changes that could play a role in the development of HAND.

  4. Smart printing technology for counterfeit deterrence

    Science.gov (United States)

    Harrop, Peter J.

    1996-03-01

    Smart (intelligent) printing is the creation of useful patterns beyond alphanumerics and graphics immediately obvious to the human eye. It employs smart inks, patterns, surfaces and substrates. Recent proliferation of color copiers, personal computers and scanners has facilitated a tenfold increase in counterfeiting in many countries over the past three years. Banknotes, cheques, academic certificates, art work, visitors passes, venue tickets and many other artifacts have been compromised. Paradoxically, the best counterfeits produced by some foreign governments and organized crime are rarely the main problem. The secret services of many countries use forensic science to great effect in pursuing these fairly readily identified sources of limited number. Bad counterfeits usually made on color copiers or computers, with or without color scanners, are the most difficult to combat because they are made by very large numbers of casual counterfeiters who may never commit crime again. For instance, counterfeit banknotes intercepted by the Bundesbank have been photocopies in a fluctuating range of 50 - 84% of cases in the last four reported years. Cheque and other document fraud is also inflated by these burgeoning bad copies and here we must add amateurish alterations using copiers or scanners. For instance, a better academic degree can mean a better job, an interbank transfer form can be 'raised' in value by enormous amounts. The issuer of a 'bad' counterfeit does not mind that it is usually picked up on a second transferral. They are long gone by then or, with banknotes, they can deny that they issued it. First priority in reversing the upward trend of counterfeiting must not therefore be the creation of better secret features traceable by forensic laboratories over extended periods of time. Rather we need better and more obvious optically unique features, not easily emulated, that can be spotted in the split second when several, say, banknotes are handed over in a

  5. The Female Genital Tract Microbiome Is Associated With Vaginal Antiretroviral Drug Concentrations in Human Immunodeficiency Virus-Infected Women on Antiretroviral Therapy.

    Science.gov (United States)

    Donahue Carlson, Renee; Sheth, Anandi N; Read, Timothy D; Frisch, Michael B; Mehta, C Christina; Martin, Amy; Haaland, Richard E; Patel, Anar S; Pau, Chou-Pong; Kraft, Colleen S; Ofotokun, Igho

    2017-11-15

    The female genital tract (FGT) microbiome may affect vaginal pH and other factors that influence drug movement into the vagina. We examined the relationship between the microbiome and antiretroviral concentrations in the FGT. Over one menstrual cycle, 20 human immunodeficiency virus (HIV)-infected women virologically suppressed on tenofovir (TFV) disoproxil fumarate/emtricitabine and ritonavir-boosted atazanavir (ATV) underwent serial paired cervicovaginal and plasma sampling for antiretroviral concentrations using high-performance liquid chromatography-tandem mass spectrometry. Analysis of 16S ribosomal RNA gene sequencing of cervicovaginal lavage clustered each participant visit into a unique microbiome community type (mCT). Participants were predominantly African American (95%), with a median age of 38 years. Cervicovaginal lavage sequencing (n = 109) resulted in a low-diversity mCT dominated by Lactobacillus (n = 40), and intermediate-diversity (n = 28) and high-diversity (n = 41) mCTs with abundance of anaerobic taxa. In multivariable models, geometric mean FGT:plasma ratios varied significantly by mCT for all 3 drugs. For both ATV and TFV, FGT:plasma was significantly lower in participant visits with high- and low-diversity mCT groups (all P < .02). For emtricitabine, FGT:plasma was significantly lower in participant visits with low- vs intermediate-diversity mCT groups (P = .002). Certain FGT mCTs are associated with decreased FGT antiretroviral concentrations. These findings are relevant for optimizing antiretrovirals used for biomedical HIV prevention in women. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  6. Different origin of adipogenic stem cells influences the response to antiretroviral drugs

    Energy Technology Data Exchange (ETDEWEB)

    Gibellini, Lara; De Biasi, Sara; Nasi, Milena; Carnevale, Gianluca; Pisciotta, Alessandra; Bianchini, Elena; Bartolomeo, Regina [Department of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia School of Medicine, Via Campi 287, 41125 Modena (Italy); Polo, Miriam [Department of Pharmacology, University of Valencia, Av.da Blasco Ibáñez 15, Valencia (Spain); FISABIO–Hospital Universitario Dr. Peset, Av.da Gaspar Aguilar 90, Valencia (Spain); De Pol, Anto [Department of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia School of Medicine, Via Campi 287, 41125 Modena (Italy); Dipartimento Sperimentale Interaziendale, Campus San Lazzaro, University of Modena and Reggio Emilia, 42122 Reggio Emilia (Italy); Pinti, Marcello [Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 287, 41125 Modena (Italy); Cossarizza, Andrea, E-mail: andrea.cossarizza@unimore.it [Department of Surgery, Medicine, Dentistry and Morphological Sciences, University of Modena and Reggio Emilia School of Medicine, Via Campi 287, 41125 Modena (Italy); Dipartimento Sperimentale Interaziendale, Campus San Lazzaro, University of Modena and Reggio Emilia, 42122 Reggio Emilia (Italy)

    2015-10-01

    Lipodystrophy (LD) is a main side effect of antiretroviral therapy for HIV infection, and can be provoked by nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors (PIs). LD exists in different forms, characterized by fat loss, accumulation, or both, but its pathogenesis is still unclear. In particular, few data exist concerning the effects of antiretroviral drugs on adipocyte differentiation. Adipose tissue can arise either from mesenchymal stem cells (MSCs), that include bone marrow-derived MSCs (hBM-MSCs), or from ectodermal stem cells, that include dental pulp stem cells (hDPSCs). To analyze whether the embryonal origin of adipocytes might impact the occurrence of different phenotypes in LD, we quantified the effects of several antiretroviral drugs on the adipogenic differentiation of hBM-MSCs and hDPSCs. hBM-MSCs and hDPSCs were isolated from healthy donors. Cells were treated with 10 and 50 μM stavudine (d4T), efavirenz (EFV), atazanavir (ATV), ritonavir (RTV), and ATV-boosted RTV. Viability and adipogenesis were evaluated by staining with propidium iodide, oil red, and adipoRed; mRNA levels of genes involved in adipocyte differentiation, i.e. CCAAT/enhancer-binding protein alpha (CEBPα) and peroxisome proliferator-activated receptor gamma (PPARγ), and in adipocyte functions, i.e. fatty acid synthase (FASN), fatty acid binding protein-4 (FABP4), perilipin-1 (PLIN1) and 1-acylglycerol-3-phosphate O-acyltransferase-2 (AGPAT2), were quantified by real time PCR. We found that ATV, RTV, EFV, and ATV-boosted RTV, but not d4T, caused massive cell death in both cell types. EFV and d4T affected the accumulation of lipid droplets and induced changes in mRNA levels of genes involved in adipocyte functions in hBM-MSCs, while RTV and ATV had little effects. All drugs stimulated the accumulation of lipid droplets in hDPSCs. Thus, the adipogenic differentiation of human stem cells can be influenced by antiretroviral drugs, and depends, at least in

  7. Different origin of adipogenic stem cells influences the response to antiretroviral drugs

    International Nuclear Information System (INIS)

    Gibellini, Lara; De Biasi, Sara; Nasi, Milena; Carnevale, Gianluca; Pisciotta, Alessandra; Bianchini, Elena; Bartolomeo, Regina; Polo, Miriam; De Pol, Anto; Pinti, Marcello; Cossarizza, Andrea

    2015-01-01

    Lipodystrophy (LD) is a main side effect of antiretroviral therapy for HIV infection, and can be provoked by nucleoside reverse transcriptase inhibitors (NRTIs) and protease inhibitors (PIs). LD exists in different forms, characterized by fat loss, accumulation, or both, but its pathogenesis is still unclear. In particular, few data exist concerning the effects of antiretroviral drugs on adipocyte differentiation. Adipose tissue can arise either from mesenchymal stem cells (MSCs), that include bone marrow-derived MSCs (hBM-MSCs), or from ectodermal stem cells, that include dental pulp stem cells (hDPSCs). To analyze whether the embryonal origin of adipocytes might impact the occurrence of different phenotypes in LD, we quantified the effects of several antiretroviral drugs on the adipogenic differentiation of hBM-MSCs and hDPSCs. hBM-MSCs and hDPSCs were isolated from healthy donors. Cells were treated with 10 and 50 μM stavudine (d4T), efavirenz (EFV), atazanavir (ATV), ritonavir (RTV), and ATV-boosted RTV. Viability and adipogenesis were evaluated by staining with propidium iodide, oil red, and adipoRed; mRNA levels of genes involved in adipocyte differentiation, i.e. CCAAT/enhancer-binding protein alpha (CEBPα) and peroxisome proliferator-activated receptor gamma (PPARγ), and in adipocyte functions, i.e. fatty acid synthase (FASN), fatty acid binding protein-4 (FABP4), perilipin-1 (PLIN1) and 1-acylglycerol-3-phosphate O-acyltransferase-2 (AGPAT2), were quantified by real time PCR. We found that ATV, RTV, EFV, and ATV-boosted RTV, but not d4T, caused massive cell death in both cell types. EFV and d4T affected the accumulation of lipid droplets and induced changes in mRNA levels of genes involved in adipocyte functions in hBM-MSCs, while RTV and ATV had little effects. All drugs stimulated the accumulation of lipid droplets in hDPSCs. Thus, the adipogenic differentiation of human stem cells can be influenced by antiretroviral drugs, and depends, at least in

  8. A Framework for Counterfeit Smart Grid Device Detection

    Energy Technology Data Exchange (ETDEWEB)

    Babun, Leonardo [Florida Intl Univ., Miami, FL (United States); Aksu, Hidayet [Florida Intl Univ., Miami, FL (United States); Uluagac, A. Selcuk [Florida Intl Univ., Miami, FL (United States)

    2016-10-19

    The core vision of the smart grid concept is the realization of reliable two-­way communications between smart devices (e.g., IEDs, PLCs, PMUs). The benefits of the smart grid also come with tremendous security risks and new challenges in protecting the smart grid systems from cyber threats. Particularly, the use of untrusted counterfeit smart grid devices represents a real problem. Consequences of propagating false or malicious data, as well as stealing valuable user or smart grid state information from counterfeit devices are costly. Hence, early detection of counterfeit devices is critical for protecting smart grid’s components and users. To address these concerns, in this poster, we introduce our initial design of a configurable framework that utilize system call tracing, library interposition, and statistical techniques for monitoring and detection of counterfeit smart grid devices. In our framework, we consider six different counterfeit device scenarios with different smart grid devices and adversarial seZings. Our initial results on a realistic testbed utilizing actual smart-­grid GOOSE messages with IEC-­61850 communication protocol are very promising. Our framework is showing excellent rates on detection of smart grid counterfeit devices from impostors.

  9. Systematic review of antiretroviral-associated lipodystrophy: lipoatrophy, but not central fat gain, is an antiretroviral adverse drug reaction.

    Directory of Open Access Journals (Sweden)

    Reneé de Waal

    Full Text Available BACKGROUND: Lipoatrophy and/or central fat gain are observed frequently in patients on antiretroviral therapy (ART. Both are assumed to be antiretroviral adverse drug reactions. METHODS: We conducted a systematic review to determine whether fat loss or gain was more common in HIV-infected patients on ART than in uninfected controls; was associated with specific antiretrovirals; and would reverse after switching antiretrovirals. RESULTS: Twenty-seven studies met our inclusion criteria. One cohort study reported more lipoatrophy, less subcutaneous fat gain, but no difference in central fat gain in HIV-infected patients on ART than in controls. Randomised controlled trials (RCTs showed more limb fat loss (or less fat gain with the following regimens: stavudine (versus other nucleoside reverse transcriptase inhibitors (NRTIs; efavirenz (versus protease inhibitors (PIs; and NRTI-containing (versus NRTI-sparing. RCTs showed increased subcutaneous fat after switching to NRTI-sparing regimens or from stavudine/zidovudine to abacavir/tenofovir. There were no significant between-group differences in trunk and/or visceral fat gain in RCTs of various regimens, but results from efavirenz versus PI regimens were inconsistent. There was no significant between-group differences in central fat gain in RCTs switched to NRTI-sparing regimens, or from PI-containing regimens. CONCLUSIONS: There is clear evidence of a causal relationship between NRTIs (especially thymidine analogues and lipoatrophy, with concomitant PIs possibly having an ameliorating effect or efavirenz causing additive toxicity. By contrast, central fat gain appears to be a consequence of treating HIV infection, because it is not different from controls, is not linked to any antiretroviral class, and doesn't improve on switching.

  10. HIV-1 drug resistance mutations among antiretroviral-naive HIV-1-infected patients in Asia: results from the TREAT Asia Studies to Evaluate Resistance-Monitoring Study.

    Science.gov (United States)

    Sungkanuparph, Somnuek; Oyomopito, Rebecca; Sirivichayakul, Sunee; Sirisanthana, Thira; Li, Patrick C K; Kantipong, Pacharee; Lee, Christopher K C; Kamarulzaman, Adeeba; Messerschmidt, Liesl; Law, Matthew G; Phanuphak, Praphan

    2011-04-15

    Of 682 antiretroviral-naïve patients initiating antiretroviral therapy in a prospective, multicenter human immunodeficiency virus type 1 (HIV-1) drug resistance monitoring study involving 8 sites in Hong Kong, Malaysia, and Thailand, the prevalence of patients with ≥1 drug resistance mutation was 13.8%. Primary HIV drug resistance is emerging after rapid scaling-up of antiretroviral therapy use in Asia.

  11. Free software to analyse the clinical relevance of drug interactions with antiretroviral agents (SIMARV®) in patients with HIV/AIDS.

    Science.gov (United States)

    Giraldo, N A; Amariles, P; Monsalve, M; Faus, M J

    Highly active antiretroviral therapy has extended the expected lifespan of patients with HIV/AIDS. However, the therapeutic benefits of some drugs used simultaneously with highly active antiretroviral therapy may be adversely affected by drug interactions. The goal was to design and develop a free software to facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. A comprehensive Medline/PubMed database search of drug interactions was performed. Articles that recognized any drug interactions in HIV disease were selected. The publications accessed were limited to human studies in English or Spanish, with full texts retrieved. Drug interactions were analyzed, assessed, and grouped into four levels of clinical relevance according to gravity and probability. Software to systematize the information regarding drug interactions and their clinical relevance was designed and developed. Overall, 952 different references were retrieved and 446 selected; in addition, 67 articles were selected from the citation lists of identified articles. A total of 2119 pairs of drug interactions were identified; of this group, 2006 (94.7%) were drug-drug interactions, 1982 (93.5%) had an identified pharmacokinetic mechanism, and 1409 (66.5%) were mediated by enzyme inhibition. In terms of clinical relevance, 1285 (60.6%) drug interactions were clinically significant in patients with HIV (levels 1 and 2). With this information, a software program that facilitates identification and assessment of the clinical relevance of antiretroviral drug interactions (SIMARV ® ) was developed. A free software package with information on 2119 pairs of antiretroviral drug interactions was designed and developed that could facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. THE EMERGENCE OF THE EUROPEAN COUNTERFEIT MARKETS

    Directory of Open Access Journals (Sweden)

    Loredana Maftei

    2013-07-01

    Full Text Available The European market of counterfeit goods has become a subject of increasing concern for businesses, private firms and policymakers. With a growing demand in consumption for this kind of goods, each sector is damaged from the toy industries to the pharmaceuticals industry. This article is aimed to expose the dynamic of the European counterfeiting markets, to highlight the main factors of production, the main providers, the smuggling routes, the overall profit, the main counterfeit products and also to offer a general perspective on the affected European markets.

  13. Medicines counterfeiting is a complex problem: a review of key challenges across the supply chain.

    Science.gov (United States)

    Tremblay, Michael

    2013-02-01

    The paper begins by asking why there is a market for counterfeit medicines, which in effect creates the problem of counterfeiting itself. Contributing factors include supply chain complexity and the lack of whole-systems thinking. These two underpin the author's view that counterfeiting is a complex (i.e. wicked) problem, and that corporate, public policy and regulatory actions need to be mindful of how their actions may be causal. The paper offers a problem-based review of key components of this complexity, viz., the knowledge end-users/consumers have of medicines; whether restrictive information policies may hamper information provision to patients; the internet's direct access to consumers; internet-enabled distribution of unsafe and counterfeit medicines; whether the internet is a parallel and competitive supply chain to legitimate routes; organised crime as an emerging medicines manufacturer and supplier and whether substandard medicines is really the bigger problem. Solutions respect the perceived complexity of the supply chain challenges. The paper identifies the need to avoid technologically-driven solutions, calling for 'technological agnosticism'. Both regulation and public policy need to reflect the dynamic nature of the problem and avoid creating perverse incentives; it may be, for instance, that medicines pricing and reimbursement policies, which affect consumer/patient access may act as market signals to counterfeiters, since this creates a cash market in cheaper drugs.

  14. Establishment of a Fast Chemical Identification System for screening of counterfeit drugs of macrolide antibiotics.

    Science.gov (United States)

    Hu, Chang-Qin; Zou, Wen-Buo; Hu, Wang-Sheng; Ma, Xiao-Kang; Yang, Min-Zhi; Zhou, Shi-Lin; Sheng, Jin-Fang; Li, Yuan; Cheng, Shuang-Hong; Xue, Jing

    2006-01-23

    A Fast Chemical Identification System (FCIS) consisting of two colour reactions based on functional groups in molecules of macrolide antibiotics and two TLC methods was developed for screening of fake macrolide drugs. The active ingredients could be extracted from their oral preparations by absolute alcohol. Sulfuric acid reaction as a common reaction of macrolides was first used to distinguish the macrolides from other types of drugs and then 16-membered macrolides and 14-membered ones were distinguished by potassium permanganate reactions depending on the time of loss of colour in the test solution; after which a TLC method carried out on a GF(254) plate (5 cm x 10 cm) was chosen to further identification of the macrolides. The mobile phase A consisting of ethyl acetate, hexane and ammonia (100:15:15, v/v) was used for the identification of 14-membered macrolides, and the mobile phase B consisting of trichloromethane, methanol and ammonia (100:5:1, v/v) was used for the identification of 16-membered ones. A suspected counterfeit macrolide preparation can be identified within 40 min. The system can be used under different conditions and has the virtues of robustness, simplicity and speed.

  15. Nanoparticle-based drug delivery to improve the efficacy of antiretroviral therapy in the central nervous system

    Directory of Open Access Journals (Sweden)

    Gomes MJ

    2014-04-01

    Full Text Available Maria João Gomes,1 José das Neves,1,2 Bruno Sarmento1,2 1Instituto de Engenharia Biomédica (INEB, Porto, Portugal; 2Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde (IINFACTS, Instituto Superior de Ciências da Saúde-Norte, CESPU, Gandra, Portugal Abstract: Antiretroviral drug therapy plays a cornerstone role in the treatment of human immunodeficiency virus (HIV/acquired immunodeficiency syndrome patients. Despite obvious advances over the past 3 decades, new approaches toward improved management of infected individuals are still required. Drug distribution to the central nervous system (CNS is required in order to limit and control viral infection, but the presence of natural barrier structures, in particular the blood–brain barrier, strongly limits the perfusion of anti-HIV compounds into this anatomical site. Nanotechnology-based approaches may help providing solutions for antiretroviral drug delivery to the CNS by potentially prolonging systemic drug circulation, increasing the crossing and reducing the efflux of active compounds at the blood–brain barrier, and providing cell/tissue-targeting and intracellular drug delivery. After an initial overview on the basic features of HIV infection of the CNS and barriers to active compound delivery to this anatomical site, this review focuses on recent strategies based on antiretroviral drug-loaded solid nanoparticles and drug nanosuspensions for the potential management of HIV infection of the CNS. Keywords: HIV/AIDS, blood–brain barrier, protease inhibitors, efflux transporters, drug targeting

  16. Counterfeit Goods and Income Inequality

    OpenAIRE

    Stefania Scandizzo

    2001-01-01

    This paper examines the effect of counterfeit goods in a world where consumers are differentiated by level of income and innovation is quality enhancing. Counterfeit goods are defined as products with the same characteristics as “originals”, but of lower quality. The effect of imitation on firms’ profits and consumer welfare depends on the distribution of income within the country. In particular, the greater the level of income inequality the larger the increase in consumer welfare due to the...

  17. Does Access to Antiretroviral Drugs Lead to an Increase in High ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    scale distribution of antiretroviral drugs needs to be critically examined – the positives have been outlined above so let us take a look at another potential facet altogether. First let us agree that the large-scale influx of ART is changing the perception of HIV: from a disease inevitably incurring suffering and death to a less ...

  18. Development of anti-counterfeit consumer product authentication system

    Directory of Open Access Journals (Sweden)

    Olena V. Narimanova

    2015-06-01

    Full Text Available Aim of the research is to develop an anti-counterfeit consumer product authentication system. The main requirements for this system are formulated, the choice of method of consumer product authentication is substantiated. The scheme of anti-counterfeit consumer product authentication system is developed basing on previously proposed method of checking the QR-code integrity and authenticity. The proposed within the system consumer product authentication technology is simple, economical for implementation, does not require the external changes of product packaging, does not affect existing production process. The technology can be recommended for the use to private businesses and government institutions that are interested in the security of their products from counterfeiting, as well as tracking and removing from circulation the counterfeit consumer products.

  19. [Injecting drug users and antiretroviral therapy: perceptions of pharmacy teams].

    Science.gov (United States)

    Yokaichiya, Chizuru Minami; Figueiredo, Wagner dos Santos; Schraiber, Lilia Blima

    2007-12-01

    To understand the perceptions of pharmacy teams about their role in the healthcare assistance challenges and adherence to antiretroviral therapy by injecting drug users living with HIV/AIDS. Qualitative study through focus groups and thematic discourse analysis of pharmacists, technicians and assistants with more than six months of experience with medication supply, in 15 assisting units for STD/AIDS in the city of São Paulo, in 2002. Three groups were formed, totaling 29 participants, originating from 12 out of the 15 existing services, and including 12 university level professionals and 17 high-school level professionals. The groups concluded that the pharmacy has an important role in the antiretroviral drug supply, which is reflected in the treatment adherence, because trust-based relationships can be built up through their procedures. In spite of this, they pointed out that such building-up does not take place through excessively bureaucratic activities. This has negative repercussions for all patients, especially for injecting drug users, considered "difficult people". Such concept sums up their behavior: they are supposed to be confused and incapable to adhere to treatment, and have limited understanding. Staff members, however, affirm they treat these patients equally. They do not realize that, by this acting, the specific needs of injecting drug users may become invisible in the service. There is also the possibility that stigmatizing stereotypes may be created, resulting in yet another barrier to the work on adherence. Although the pharmacy is recommended as a potentially favorable place to listen to and form bonds with users, the results show objective and subjective obstacles to render it suitable for the work on adherence.

  20. Comparison of cyclic fatigue resistance of original and counterfeit rotary instruments.

    Science.gov (United States)

    Ertas, Huseyin; Capar, Ismail Davut; Arslan, Hakan; Akan, Ender

    2014-05-31

    In recent years, with the advances in counterfeiting methods, counterfeit products have reached the dental market. The purpose of this study was to compare the cyclic fatigue resistance of original and counterfeit rotary root canal instruments. The cyclic fatigue of original and counterfeit ProTaper F2 endodontic instruments was tested (n = 20) in 3 mm radius steel canals with a 60° angle of curvature. The number of cycles to fracture (NCF) was calculated, and the data were subjected to the Student's t-test (α = 0.05). The original instruments showed better cyclic fatigue resistance than the counterfeit ones (p instruments was very low. As a result, clinicians should be careful not to purchase counterfeit products.

  1. Small-molecule inhibition of HIV pre-mRNA splicing as a novel antiretroviral therapy to overcome drug resistance.

    Directory of Open Access Journals (Sweden)

    Nadia Bakkour

    2007-10-01

    Full Text Available The development of multidrug-resistant viruses compromises antiretroviral therapy efficacy and limits therapeutic options. Therefore, it is an ongoing task to identify new targets for antiretroviral therapy and to develop new drugs. Here, we show that an indole derivative (IDC16 that interferes with exonic splicing enhancer activity of the SR protein splicing factor SF2/ASF suppresses the production of key viral proteins, thereby compromising subsequent synthesis of full-length HIV-1 pre-mRNA and assembly of infectious particles. IDC16 inhibits replication of macrophage- and T cell-tropic laboratory strains, clinical isolates, and strains with high-level resistance to inhibitors of viral protease and reverse transcriptase. Importantly, drug treatment of primary blood cells did not alter splicing profiles of endogenous genes involved in cell cycle transition and apoptosis. Thus, human splicing factors represent novel and promising drug targets for the development of antiretroviral therapies, particularly for the inhibition of multidrug-resistant viruses.

  2. The effects of luxury conceptualization on counterfeit purchase an empirical study

    OpenAIRE

    Simona Romani; Stefano Pace; Giacomo Gistri

    2011-01-01

    The extant literature on luxury counterfeiting examines a wide range of antecedents of counterfeit purchase (such as product attributes, socio-demographic factors, and various consumer attitudes). However, less attention has been devoted to the luxury conceptualization held by consumers. This study argues that luxury value perception can be a multidimensional antecedent of counterfeit purchase, and therefore investigates whether 1) consumers of counterfeits and originals differ in their perce...

  3. Challenging Near InfraRed Spectroscopy discriminating ability for counterfeit pharmaceuticals detection

    Energy Technology Data Exchange (ETDEWEB)

    Storme-Paris, I. [Groupe de Chimie Analytique de Paris-Sud, EA 4041, IFR 141, School of Pharmacy, Univ Paris-Sud, 5 rue Jean Baptiste Clement, 92296 Chatenay-Malabry (France); Rebiere, H. [Laboratories and Control Department, French Health Products Safety Agency (AFSSAPS), 635 rue de la Garenne, 34740 Vendargues (France); Matoga, M. [Groupe de Chimie Analytique de Paris-Sud, EA 4041, IFR 141, School of Pharmacy, Univ Paris-Sud, 5 rue Jean Baptiste Clement, 92296 Chatenay-Malabry (France); Civade, C.; Bonnet, P.-A.; Tissier, M.H. [Laboratories and Control Department, French Health Products Safety Agency (AFSSAPS), 635 rue de la Garenne, 34740 Vendargues (France); Chaminade, P., E-mail: pierre.chaminade@u-psud.fr [Groupe de Chimie Analytique de Paris-Sud, EA 4041, IFR 141, School of Pharmacy, Univ Paris-Sud, 5 rue Jean Baptiste Clement, 92296 Chatenay-Malabry (France)

    2010-01-25

    This study was initiated by the laboratories and control department of the French Health Products Safety Agency (AFSSAPS) as part of the fight against the public health problem of rising counterfeit and imitation medicines. To test the discriminating ability of Near InfraRed Spectroscopy (NIRS), worse cases scenarios were first considered for the discrimination of various pharmaceutical final products containing the same Active Pharmaceutical Ingredient (API) with different excipients, such as generics of proprietary medicinal products (PMP). Two generic databases were explored: low active strength hard capsules of Fluoxetine and high strength tablets of Ciprofloxacin. Then 4 other cases involving suspicious samples, counterfeits and imitations products were treated. In all these cases, spectral differences between samples were studied, giving access to API or excipient contents information, and eventually allowing manufacturing site identification. A chemometric background is developed to explain the optimisation methodology, consisting in the choices of appropriate pretreatments, algorithms for data exploratory analyses (unsupervised Principal Component Analysis), and data classification (supervised cluster analysis, and Soft Independent Modelling of Class Analogy). Results demonstrate the high performance of NIRS, highlighting slight differences in formulations, such as 2.5% (w/w) in API strength, 1.0% (w/w) in excipient and even coating variations (<1%, w/w) with identical contents, approaching the theoretical limits of NIRS sensitivity. All the different generic formulations were correctly discriminated and foreign PMP, constituted of formulations slightly different from the calibration ones, were also all discriminated. This publication addresses the ability of NIRS to detect counterfeits and imitations and presents the NIRS as an ideal tool to master the global threat of counterfeit drugs.

  4. Challenging Near InfraRed Spectroscopy discriminating ability for counterfeit pharmaceuticals detection

    International Nuclear Information System (INIS)

    Storme-Paris, I.; Rebiere, H.; Matoga, M.; Civade, C.; Bonnet, P.-A.; Tissier, M.H.; Chaminade, P.

    2010-01-01

    This study was initiated by the laboratories and control department of the French Health Products Safety Agency (AFSSAPS) as part of the fight against the public health problem of rising counterfeit and imitation medicines. To test the discriminating ability of Near InfraRed Spectroscopy (NIRS), worse cases scenarios were first considered for the discrimination of various pharmaceutical final products containing the same Active Pharmaceutical Ingredient (API) with different excipients, such as generics of proprietary medicinal products (PMP). Two generic databases were explored: low active strength hard capsules of Fluoxetine and high strength tablets of Ciprofloxacin. Then 4 other cases involving suspicious samples, counterfeits and imitations products were treated. In all these cases, spectral differences between samples were studied, giving access to API or excipient contents information, and eventually allowing manufacturing site identification. A chemometric background is developed to explain the optimisation methodology, consisting in the choices of appropriate pretreatments, algorithms for data exploratory analyses (unsupervised Principal Component Analysis), and data classification (supervised cluster analysis, and Soft Independent Modelling of Class Analogy). Results demonstrate the high performance of NIRS, highlighting slight differences in formulations, such as 2.5% (w/w) in API strength, 1.0% (w/w) in excipient and even coating variations (<1%, w/w) with identical contents, approaching the theoretical limits of NIRS sensitivity. All the different generic formulations were correctly discriminated and foreign PMP, constituted of formulations slightly different from the calibration ones, were also all discriminated. This publication addresses the ability of NIRS to detect counterfeits and imitations and presents the NIRS as an ideal tool to master the global threat of counterfeit drugs.

  5. HIV-1 drug resistance in recently HIV-infected pregnant mother's naïve to antiretroviral therapy in Dodoma urban, Tanzania.

    Science.gov (United States)

    Vairo, Francesco; Nicastri, Emanuele; Liuzzi, Giuseppina; Chaula, Zainab; Nguhuni, Boniface; Bevilacqua, Nazario; Forbici, Federica; Amendola, Alessandra; Fabeni, Lavinia; De Nardo, Pasquale; Perno, Carlo Federico; Cannas, Angela; Sakhoo, Calistus; Capobianchi, Maria Rosaria; Ippolito, Giuseppe

    2013-09-21

    HIV resistance affects virological response to therapy and efficacy of prophylaxis in mother-to-child-transmission. The study aims to assess the prevalence of HIV primary resistance in pregnant women naïve to antiretrovirals. Cross sectional baseline analysis of a cohort of HIV + pregnant women (HPW) enrolled in the study entitled Antiretroviral Management of Antenatal and Natal HIV Infection (AMANI, peace in Kiswahili language). The AMANI study began in May 2010 in Dodoma, Tanzania. In this observational cohort, antiretroviral treatment was provided to all women from the 28th week of gestation until the end of the breastfeeding period. Baseline CD4 cell count, viral load and HIV drug-resistance genotype were collected. Drug-resistance analysis was performed on 97 naïve infected-mothers. The prevalence of all primary drug resistance and primary non-nucleoside reverse-transcriptase inhibitors resistance was 11.9% and 7.5%, respectively. K103S was found in two women with no M184V detection. HIV-1 subtype A was the most commonly identified, with a high prevalence of subtype A1, followed by C, D, C/D recombinant, A/C recombinant and A/D recombinant. HIV drug- resistance mutations were detected in A1 and C subtypes. Our study reports an 11.9% prevalence rate of primary drug resistance in naïve HIV-infected pregnant women from a remote area of Tanzania. Considering that the non-nucleoside reverse-transcriptase inhibitors are part of the first-line antiretroviral regimen in Tanzania and all of Africa, resistance surveys should be prioritized in settings where antiretroviral therapy programs are scaled up.

  6. Synergy against drug-resistant HIV-1 with the microbicide antiretrovirals, dapivirine and tenofovir, in combination.

    Science.gov (United States)

    Schader, Susan M; Colby-Germinario, Susan P; Schachter, Jordana R; Xu, Hongtao; Wainberg, Mark A

    2011-08-24

    To evaluate the candidate antiretroviral microbicide compounds, dapivirine (DAP) and tenofovir (TFV), alone and in combination against the transmission of wild-type and nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant HIV-1 from different subtypes. We determined single-drug efficacy of the RTIs, DAP and TFV, against subtype B and non-B wild-type and NNRTI-resistant HIV-1 in vitro. To assess breadth of activity, compounds were tested alone and in combination against wild-type and NNRTI-resistant subtype C primary HIV-1 isolates and complimentary clonal HIV-1 from subtypes B, C and CRF02_AG to control for viral variation. Early infection was quantified by counting light units emitted from TZM-bl cells less than 48-h postinfection. Combination ratios were based on drug inhibitory concentrations (IC(50)s) and combined effects were determined by calculating combination indices. Both candidate microbicide antiretrovirals demonstrated potent anti-NNRTI-resistant HIV-1 activity in vitro, albeit the combination protected better than the single-drug treatments. Of particular interest, the DAP with TFV combination exhibited synergy (50% combination index, CI(50) = 0.567) against subtype C NNRTI-resistant HIV-1, whereas additivity (CI(50) = 0.987) was observed against the wild-type counterpart from the same patient. The effect was not compounded by the presence of subdominant viral fractions, as experiments using complimentary clonal subtype C wild-type (CI(50) = 0.968) and NNRTI-resistant (CI(50) = 0.672) HIV-1, in lieu of the patient quasispecies, gave similar results. This study supports the notion that antiretroviral drug combinations may retain antiviral activity against some drug-resistant HIV-1 despite subtype classification and quasispecies diversity.

  7. Mass Spectrometry to Determine Intracellular Concentrations of Antiretroviral Drugs: From chemistry to clinical application

    NARCIS (Netherlands)

    J.J.A. van Kampen (Jeroen)

    2009-01-01

    textabstractAround 1995 – 1996, treatment options for patients infected with the human immunodefiency virus (HIV), the causative agent of acquired immunodeficiency syndrome (AIDS) 1, 2, improved dramatically. Therapy with a combination of several classes of antiretroviral drugs resulted in a

  8. 19 CFR 133.21 - Articles bearing counterfeit trademarks.

    Science.gov (United States)

    2010-04-01

    ... 19 Customs Duties 1 2010-04-01 2010-04-01 false Articles bearing counterfeit trademarks. 133.21... Recorded Trademarks or Recorded Trade Names § 133.21 Articles bearing counterfeit trademarks. (a... substantially indistinguishable from, a registered trademark. (b) Seizure. Any article of domestic or foreign...

  9. Counterfeit Electronic Cigarette Products with Mislabeled Nicotine Concentrations.

    Science.gov (United States)

    Omaiye, Esther E; Cordova, Iliana; Davis, Barbara; Talbot, Prue

    2017-07-01

    We compared nicotine concentrations in one brand of refill fluids that were purchased in 4 countries and labeled 0 mg of nicotine/mL. We then identified counterfeit e-cigarette products from these countries. Overall, 125 e-cigarette refill fluids were purchased in Nigeria, the United States (US), England, and China. Nicotine concentrations were measured using high performance liquid chromatography and compared to labeled concentrations. Refill fluids were examined to identify physical differences and grouped into authentic and counterfeit products. Whereas nicotine was in 51.7% (15/29) of the Nigerian, 3.7% (1/27) of the Chinese and 1.6% (1/61) of the American refill fluids (range = 0.4 - 20.4 mg/mL), 8 British products did not contain nicotine. Products from China, the US, and Nigeria with trace amounts of nicotine (0.4 to 0.6 mg/mL) were authentic; however, all products from Nigeria with more than 3.7 mg/mL were counterfeit. We introduce 2 novel issues in the e-cigarette industry, the production of counterfeit refill fluids under a brandjacked label and inclusion of nicotine in 81.3% of the counterfeit products labeled 0 mg/mL. This study emphasizes the need for better control and monitoring of nicotine containing products and sales outlets.

  10. Rates of inappropriate antiretroviral prescription among injection drug users

    Directory of Open Access Journals (Sweden)

    Bonner Simon

    2007-01-01

    Full Text Available Abstract Background Although the survival benefits of antiretroviral therapy (ART for the treatment of HIV infection are well established, the clinical management of HIV disease continues to present major challenges. There are particular concerns regarding access to appropriate HIV treatment among HIV-infected injection drug users (IDU. Methods In a prospective cohort study of HIV-infected IDU in Vancouver, Canada, we examined initial ART regimens vis-à-vis the provincial government's therapeutic guidelines at the time ART was initiated. Briefly, there have been four sets of guidelines: Era 1 (1992 to November 1995; double-drug (dual NRTIs ART for patients with a CD4 cell count of 350 or less; Era 2 (December 1995 to May 1996; double-drug therapy for patients with a CD4+ cell count of 500 or less; Era 3 (June 1996 to June 1997; triple-drug therapy (dual NRTIs with a PI or NNRTI for patients who had a plasma viral load of > 100,000 HIV-1 RNA copies/mL; dual therapy with two NRTIs for those with a plasma viral load of 5,000 to 100,000 HIV-1 RNA copies/mL; Era 4 (since July 1997; universal use of triple drug therapy as first-line treatment. Results Between May 1996 and May 2003, 431 HIV-infected individuals were enrolled into the cohort. By May 31, 2003, 291 (67.5% individuals had initiated ART. We noted instances of inappropriate antiretroviral prescription in each guideline era, with 9 (53% in Era 1, 3 (12% in Era 2, 22 (28% in Era 3, and 23 (15% in Era 4. Of the 57 subjects who received an inappropriate ART regimen initially, 14 never received the appropriate therapy; among the remaining 43, the median time to the initiation of a guideline-appropriate ART regimen was 12 months (inter-quartile range 5 – 20. Conclusion The present study identified measurable rates of guideline-inappropriate ART prescription for patients who were injection drug users. Rates were highest in the era of dual therapy, although high rates persisted into the triple

  11. The prevalence of antiretroviral multidrug resistance in highly active antiretroviral therapy-treated patients with HIV/AIDS between 2004 and 2009 in South Korea.

    Science.gov (United States)

    Choi, Ju-yeon; Kwon, Oh-Kyung; Choi, Byeong-Sun; Kee, Mee-Kyung; Park, Mina; Kim, Sung Soon

    2014-06-01

    Highly active antiretroviral therapy (HAART) including protease inhibitors (PIs) has been used in South Korea since 1997. Currently, more than 20 types of antiretroviral drugs are used in the treatment of human immunodeficiency virus-infected/acquired immune deficiency syndrome patients in South Korea. Despite the rapid development of various antiretroviral drugs, many drug-resistant variants have been reported after initiating HAART, and the efficiency of HAART is limited by these variants. To investigate and estimate the annual antiretroviral drug resistance and prevalence of antiretroviral multi-class drug resistance in Korean patients with experience of treatment. The amplified HIV-1 pol gene in 535 patients requested for genotypic drug resistance testing from 2004 to 2009 by the Korea Centers for Disease Control and Prevention was sequenced and analyzed annually and totally. The prevalence of antiretroviral drug resistance was estimated based on "SIR" interpretation of the Stanford sequence database. Of viruses derived from 787 specimens, 380 samples (48.3%) showed at least one drug class-related resistance. Predicted NRTI drug resistance was highest at 41.9%. NNRTI showed 27.2% resistance with 23.3% for PI. The percent of annual drug resistance showed similar pattern and slightly declined except 2004 and 2005. The prevalence of multi-class drug resistance against each drug class was: NRTI/NNRTI/PI, 9.8%; NRTI/PI, 21.9%; NNRTI/PI, 10.4%; and NRTI/NNRTI, 21.5%. About 50% and less than 10% of patients infected with HIV-1 have multidrug and multiclass resistance linked to 16 antiretroviral drugs, respectively. The significance of this study lies in its larger-scale examination of the prevalence of drug-resistant variants and multidrug resistance in HAART-experienced patients in South Korea. Copyright © 2014 Elsevier B.V. All rights reserved.

  12. An NFC-Enabled Anti-Counterfeiting System for Wine Industry

    OpenAIRE

    Yiu, Neo C. K.

    2016-01-01

    Wine counterfeiting is not a new problem, however, the situation in China has been going worse even after Hong Kong manifested itself as a wine trading and distribution center with abolishing all taxes on wine in 2008. The most basic method, printing a fake label with a subtly misspelled brand name or a slightly different logo in hopes of fooling wine consumers, has been common to other luxury-goods markets prone to counterfeiting. More ambitious counterfeiters might remove an authentic label...

  13. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults

    Science.gov (United States)

    Günthard, Huldrych F.; Saag, Michael S.; Benson, Constance A.; del Rio, Carlos; Eron, Joseph J.; Gallant, Joel E.; Hoy, Jennifer F.; Mugavero, Michael J.; Sax, Paul E.; Thompson, Melanie A.; Gandhi, Rajesh T.; Landovitz, Raphael J.; Smith, Davey M.; Jacobsen, Donna M.; Volberding, Paul A.

    2016-01-01

    IMPORTANCE New data and therapeutic options warrant updated recommendations for the use of antiretroviral drugs (ARVs) to treat or to prevent HIV infection in adults. OBJECTIVE To provide updated recommendations for the use of antiretroviral therapy in adults (aged ≥18 years) with established HIV infection, including when to start treatment, initial regimens, and changing regimens, along with recommendations for using ARVs for preventing HIV among those at risk, including preexposure and postexposure prophylaxis. EVIDENCE REVIEW A panel of experts in HIV research and patient care convened by the International Antiviral Society-USA reviewed data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences since the 2014 report, for new data or evidence that would change previous recommendations or their ratings. Comprehensive literature searches were conducted in the PubMed and EMBASE databases through April 2016. Recommendations were by consensus, and each recommendation was rated by strength and quality of the evidence. FINDINGS Newer data support the widely accepted recommendation that antiretroviral therapy should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. Recommended optimal initial regimens for most patients are 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). Other effective regimens include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with 2 NRTIs. Recommendations for special populations and in the settings of opportunistic infections and concomitant conditions are provided. Reasons for switching therapy include convenience, tolerability, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy, elimination of food restrictions, virologic failure, or drug toxicities. Laboratory

  14. The impact of counterfeit products on the market

    OpenAIRE

    Tkachov, Maksim

    2015-01-01

    The author proves that the level of counterfeit presentation of goods on the market directly affects the equilibrium of the market. The greater the number of counterfeit products, the greater the level of losses holders of intellectual property rights, the lower the level of consumer confidence to the market.

  15. Genotypic drug resistance and long-term mortality in patients with triple-class antiretroviral drug failure

    DEFF Research Database (Denmark)

    Lohse, Nicolai; Jørgensen, LB; Kronborg, G

    2007-01-01

    OBJECTIVE: To examine the prevalence of drug-resistance-associated mutations in HIV patients with triple-drug class virological failure (TCF) and their association with long-term mortality. DESIGN: Population-based study from the Danish HIV Cohort Study (DHCS). METHODS: We included all patients...... range 2-10), and 81 (61%) patients had mutations conferring resistance towards all three major drug classes. In a regression model adjusted for CD4+ T-cell count, HIV RNA, year of TCF, age, gender and previous inferior antiretroviral therapy, harbouring > or =9 versus ... in the DHCS who experienced TCF between January 1995 and November 2004, and we performed genotypic resistance tests for International AIDS Society (IAS)-USA primary mutations on virus from plasma samples taken around the date of TCF. We computed time to all-cause death from date of TCF. The relative risk...

  16. Pharmacokinetics of antiretroviral drugs in anatomical sanctuary sites: the male and female genital tract.

    Science.gov (United States)

    Else, Laura J; Taylor, Stephen; Back, David J; Khoo, Saye H

    2011-01-01

    HIV resides within anatomical 'sanctuary sites', where local drug exposure and viral dynamics may differ significantly from the systemic compartment. Suboptimal antiretroviral concentrations in the genital tract may result in compartmentalized viral replication, selection of resistant mutations and possible re-entry of wild-type/resistant virus into the systemic circulation. Therefore, achieving adequate antiretroviral exposure in the genital tract has implications for the prevention of sexual and vertical transmission of HIV. Penetration of antiretrovirals in the genital tract is expressed by accumulation ratios derived from the measurement of drug concentrations in time-matched seminal plasma/cervicovaginal fluid and plasma samples. Penetration varies by gender and may be drug (as opposed to class) specific with high interindividual variability. Concentrations in seminal plasma are highest for nucleoside analogues and lowest for protease inhibitors and efavirenz. Seminal accumulation of newer agents, raltegravir and maraviroc, is moderate (rank order of accumulation is nucleoside/nucleotide reverse transcriptase inhibitors [lamivudine/zidovudine/tenofovir/didanosine > stavudine/abacavir] > raltegravir > indinavir/maraviroc/nevirapine > efavirenz/protease inhibitors [amprenavir/atazanavir/darunavir > lopinavir/ritonavir > saquinavir] > enfuvirtide). In the female genital tract, the nucleoside analogues exhibit high accumulation ratios, whereas protease inhibitors have limited penetration; however, substantial variability exists between individuals and study centres. Second generation non-nucleoside reverse transcriptase inhibitor etravirine, and maraviroc and raltegravir, demonstrate effective accumulation in cervicovaginal secretions (rank order of accumulation is nucleoside/nucleotide reverse transcriptase inhibitor [zidovudine/lamivudine/didanosine > emtricitabine/tenofovir] > indinavir > maraviroc/raltegravir/darunavir/etravirine > nevirapine

  17. Trends in counterfeits amphetamine-type stimulants after its prohibition in Brazil.

    Science.gov (United States)

    Mariotti, Kristiane de Cássia; Ortiz, Rafael S; Souza, Daniele Z; Mileski, Thayse C; Fröehlich, Pedro E; Limberger, Renata P

    2013-06-10

    Brazil is one of the world's highest users of anorectic drugs, mainly diethylpropione, fenproporex and sibutramine. The present work focuses on physical and chemical characteristics of 17 counterfeited capsules containing amphetamine-type stimulants (ATS) from three seizures conducted by Brazilian Federal Police. The physical profile was useful in indicating forgery, bring complementary information, but the use of this data singly was not sufficient to distinguish between authentic and counterfeited medicines. The chemical analysis revealed that the seizures capsules labeled as Desobesi-M (fenproporex 25mg), actually contained the active pharmaceutical ingrediente (API) sibutramine. The amount of this API ranged from 1/3 to 2 times the amount of drug found in commercial product, may reach twice the recommended daily dose. Multivariate analysis with application of principal component analysis on data from spectroscopy attenuated total reflectance Fourier transform infrared classified the samples according to their similarities, indicating that two seizures had common origin. This study represents the first step in the elucidation of falsification of ATS in Brazil. Considering the forensic intelligence these information are valuable in order to develop and establish a database that enables correlate samples from different locations and/or suppliers and to map the profile and trends of trafficking. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  18. Rapid instrumental detection and quantification of counterfeit pharmaceutical tablet formulations

    OpenAIRE

    Ogwu, John; Lawson, Graham; Tanna, Sangeeta

    2015-01-01

    From therapeutic to lifestyle medicines, the counterfeiting of medicines has been on the rise in recent times. Estimates indicate that about 10% of medicines worldwide are counterfeits with much higher figures in developing countries. Currently, identifying counterfeit medicines at the point of care is a challenge leaving many patients at risk. This study considered the potential use of Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy (ATR-FTIR) in rapid quantitative analy...

  19. Long-Acting Antiretrovirals: Where Are We now?

    Science.gov (United States)

    Nyaku, Amesika N; Kelly, Sean G; Taiwo, Babafemi O

    2017-04-01

    Current HIV treatment options require daily use of combination antiretroviral drugs. Many persons living with HIV experience treatment fatigue and suboptimal adherence as a result. Long-acting antiretroviral drugs are being developed to expand options for HIV treatment. Here, we review the agents in development, and evaluate data from recent clinical trials. In addition, we anticipate challenges to successful widespread use of long-acting antiretrovirals. Parenteral nanosuspensions of cabotegravir and rilpivirine, and dapivirine vaginal ring are the farthest in clinical development. Long-acting modalities in earlier development stages employ drug-loaded implants, microparticles, or targeted mutagenesis, among other innovations. Long-acting antiretroviral drugs promise new options for HIV prevention and treatment, and ways to address poor adherence and treatment fatigue. Further studies will identify the long-acting agents or combinations that are suitable for routine use. Creative solutions will be needed for anticipated implementation challenges.

  20. Counterfeit Currency Identification System - A Case Study on ...

    African Journals Online (AJOL)

    Counterfeit notes came into circulation right from the time of existence of genuine notes. A number of techniques like first line inspection methods, second line inspection methods and smart money counterfeit detector are being used in many countries to identify the genuine notes from the fake ones. The other method is ...

  1. Effect of pretreatment HIV-1 drug resistance on immunological, virological, and drug-resistance outcomes of first-line antiretroviral treatment in sub-Saharan Africa: a multicentre cohort study

    NARCIS (Netherlands)

    Hamers, Raph L.; Schuurman, Rob; Sigaloff, Kim C. E.; Wallis, Carole L.; Kityo, Cissy; Siwale, Margaret; Mandaliya, Kishor; Ive, Prudence; Botes, Mariette E.; Wellington, Maureen; Osibogun, Akin; Wit, Ferdinand W.; van Vugt, Michèle; Stevens, Wendy S.; de Wit, Tobias F. Rinke

    2012-01-01

    Background The effect of pretreatment HIV-1 drug resistance on the response to first-line combination antiretroviral therapy (ART) in sub-Saharan Africa has not been assessed. We studied pretreatment drug resistance and virological, immunological, and drug-resistance treatment outcomes in a large

  2. Economic evaluation of 3-drug antiretroviral regimens for the prevention of mother-to-child HIV transmission in Thailand.

    Science.gov (United States)

    Werayingyong, Pitsaphun; Phanuphak, Nittaya; Chokephaibulkit, Kulkunya; Tantivess, Sripen; Kullert, Nareeluk; Tosanguan, Kakanang; Butchon, Rukmanee; Voramongkol, Nipunporn; Boonsuk, Sarawut; Pilasant, Songyot; Kulpeng, Wantanee; Teerawattananon, Yot

    2015-03-01

    The current program for prevention of mother-to-child HIV transmission in Thailand recommends a 2-drugs regimen for HIV-infected pregnant women with a CD4 count >200 cells/mm(3). This study assesses the value for money of 3 antiretroviral drugs compared with zidovudine (AZT)+single-dose nevirapine (sd-NVP). A decision tree was constructed to predict costs and outcomes using the governmental perspective for assessing cost-effectiveness of 3-drug regimens: (1) AZT, lamivudine, and efavirenz and (2) AZT, 3TC, and lopinavir/ritonavir, in comparison with the current protocol, AZT+sd-NVP. The 3-drug antiretroviral regimens yield lower costs and better health outcomes compared with AZT+sd-NVP. Although these 3-drug regimens offer higher program costs and health care costs for premature birth, they save money significantly in regard to pediatric HIV treatment and treatment costs for drug resistance in mothers. The 3-drug regimens are cost-saving interventions. The findings from this study were used to support a policy change in the national recommendation. © 2013 APJPH.

  3. HIV-1 Drug Resistance Mutations Among Antiretroviral-Naïve HIV-1–Infected Patients in Asia: Results From the TREAT Asia Studies to Evaluate Resistance-Monitoring Study

    Science.gov (United States)

    Oyomopito, Rebecca; Sirivichayakul, Sunee; Sirisanthana, Thira; Kantipong, Pacharee; Lee, Christopher K. C.; Kamarulzaman, Adeeba; Messerschmidt, Liesl; Law, Matthew G.; Phanuphak, Praphan

    2011-01-01

    (See editorial commentary by Jordan on pages 1058–1060.) Of 682 antiretroviral-naïve patients initiating antiretroviral therapy in a prospective, multicenter human immunodeficiency virus type 1 (HIV-1) drug resistance monitoring study involving 8 sites in Hong Kong, Malaysia, and Thailand, the prevalence of patients with ≥1 drug resistance mutation was 13.8%. Primary HIV drug resistance is emerging after rapid scaling-up of antiretroviral therapy use in Asia. PMID:21460324

  4. Antiretroviral drug resistance in HIV-1 therapy-naive patients in Cuba.

    Science.gov (United States)

    Pérez, Lissette; Kourí, Vivian; Alemán, Yoan; Abrahantes, Yeisel; Correa, Consuelo; Aragonés, Carlos; Martínez, Orlando; Pérez, Jorge; Fonseca, Carlos; Campos, Jorge; Álvarez, Delmis; Schrooten, Yoeri; Dekeersmaeker, Nathalie; Imbrechts, Stijn; Beheydt, Gertjan; Vinken, Lore; Soto, Yudira; Álvarez, Alina; Vandamme, Anne-Mieke; Van Laethem, Kristel

    2013-06-01

    In Cuba, antiretroviral therapy rollout started in 2001 and antiretroviral therapy coverage has reached almost 40% since then. The objectives of this study were therefore to analyze subtype distribution, and level and patterns of drug resistance in therapy-naive HIV-1 patients. Four hundred and one plasma samples were collected from HIV-1 therapy-naive patients in 2003 and in 2007-2011. HIV-1 drug resistance genotyping was performed in the pol gene and drug resistance was interpreted according to the WHO surveillance drug-resistance mutations list, version 2009. Potential impact on first-line therapy response was estimated using genotypic drug resistance interpretation systems HIVdb version 6.2.0 and Rega version 8.0.2. Phylogenetic analysis was performed using Neighbor-Joining. The majority of patients were male (84.5%), men who have sex with men (78.1%) and from Havana City (73.6%). Subtype B was the most prevalent subtype (39.3%), followed by CRF20-23-24_BG (19.5%), CRF19_cpx (18.0%) and CRF18_cpx (10.3%). Overall, 29 patients (7.2%) had evidence of drug resistance, with 4.0% (CI 1.6%-4.8%) in 2003 versus 12.5% (CI 7.2%-14.5%) in 2007-2011. A significant increase in drug resistance was observed in recently HIV-1 diagnosed patients, i.e. 14.8% (CI 8.0%-17.0%) in 2007-2011 versus 3.8% (CI 0.9%-4.7%) in 2003 (OR 3.9, CI 1.5-17.0, p=0.02). The majority of drug resistance was restricted to a single drug class (75.8%), with 55.2% patients displaying nucleoside reverse transcriptase inhibitor (NRTI), 10.3% non-NRTI (NNRTI) and 10.3% protease inhibitor (PI) resistance mutations. Respectively, 20.7% and 3.4% patients carried viruses containing drug resistance mutations against NRTI+NNRTI and NRTI+NNRTI+PI. The first cases of resistance towards other drug classes than NRTI were only detected from 2008 onwards. The most frequent resistance mutations were T215Y/rev (44.8%), M41L (31.0%), M184V (17.2%) and K103N (13.8%). The median genotypic susceptibility score for the

  5. Consumption Of Counterfeit Alcohol In Contemporary Russia: The Role Of Cultural And Structural Factors

    OpenAIRE

    Zoya Kotelnikova

    2014-01-01

    The majority of Russians believe that counterfeit alcohol may cause death. Nevertheless, alcohol is a common target of counterfeiting in contemporary Russia as are branded clothes, accessories and audio products. This paper aims to reveal whether counterfeit alcohol consumers are distinctive in terms of structure and culture. It investigates the prevalence and structure of counterfeit alcohol purchasing and consumption; attitudes and beliefs about counterfeit alcohol; and predictors of counte...

  6. Do national drug policies influence antiretroviral drug prices? Evidence from the Southern African Development community.

    Science.gov (United States)

    Liu, Yao; Galárraga, Omar

    2017-03-01

    The efficacy of low- and middle-income countries’ (LMIC) national drug policies in managing antiretroviral (ARV) pharmaceutical prices is not well understood. Though ARV drug prices have been declining in LMIC over the past decade, little research has been done on the role of their national drug policies. This study aims to (i) analyse global ARV prices from 2004 to 2013 and (ii) examine the relationship of national drug policies to ARV prices. Analysis of ARV drug prices utilized data from the Global Price Reporting Mechanism from the World Health Organization (WHO). Ten of the most common ARV drugs (first-line and second-line) were selected. National drug policies were also assessed for 12 countries in the South African Development Community (SADC), which self-reported their policies through WHO surveys. The best predictor of ARV drug price was generic status—the generic versions of 8 out of 10 ARV drugs were priced lower than branded versions. However, other factors such as transaction volume, HIV prevalence, national drug policies and PEPFAR/CHAI involvement were either not associated with ARV drug price or were not consistent predictors of price across different ARV drugs. In the context of emerging international trade agreements, which aim to strengthen patent protections internationally and potentially delay the sale of generic drugs in LMIC, this study shines a spotlight on the importance of generic drugs in controlling ARV prices. Further research is needed to understand the impact of national drug policies on ARV prices.

  7. Preparation and RGB upconversion optic properties of transparent anti-counterfeiting films.

    Science.gov (United States)

    Yao, Weijing; Tian, Qingyong; Liu, Jun; Xue, Qingwen; Li, Mengxiao; Liu, Li; Lu, Qiang; Wu, Wei

    2017-10-26

    Advanced anti-counterfeiting labels have aroused an intensive interest in packaging industry to avoid the serious issue of counterfeit. However, the preparation and cost of the existing labels associated with the drawbacks, including the complex and high-cost equipment, limit the protection of the authenticity of goods. Herein, we developed a series of anti-counterfeiting labels based on multicolor upconversion micro-particles (UCMPs) inks via straightforward and low-cost solutions, including spin-coating, stamping and screen printing. The UCMPs were synthesized through a facile hydrothermal process and displayed tunable red (R), green (G) and blue (B) color by doping different lanthanide ions, which are Er 3+ /Tm 3+ , Yb 3+ /Er 3+ and Yb 3+ /Tm 3+ in NaYF 4 hosts, respectively. The optimal UCMPs inks were deposited on a flexible polyethylene terephthalate (PET) substrate to obtain transparent anti-counterfeiting labels possessing higher transmittance, stronger upconversion fluorescence intensity and good photostability. Under ambient conditions, the patterns and films were transparent, but could exhibit multicolor light under 980 nm laser excitation. They can be used as anti-counterfeiting labels for die-cutting packages to further elevate the security of goods. The tunable and designable transparent anti-counterfeiting labels based on RGB UCMPs inks exhibit the merits of low-cost, easy-manufacture and versatility, underlying the practical application in the field of anti-counterfeiting.

  8. The effect of individual antiretroviral drugs on body composition in HIV-infected persons initiating highly active antiretroviral therapy.

    Science.gov (United States)

    Shlay, Judith C; Sharma, Shweta; Peng, Grace; Gibert, Cynthia L; Grunfeld, Carl

    2009-07-01

    To examine the long-term effects of individual antiretroviral drugs on body composition among 416 persons initiating antiretroviral therapy (ART). In a substudy of a clinical trial of persons initiating ART, changes in body composition attributable to individual ART were examined. ARTs assessed were as follows: indinavir, ritonavir, nelfinavir, efavirenz, nevirapine, stavudine (d4T), zidovudine (ZDV), lamivudine (3TC), didanosine, and abacavir. Skinfolds and circumferences were measured at baseline and every 4 months. Mid arm, mid thigh, and waist subcutaneous tissue areas and nonsubcutaneous tissue areas were calculated. Rates of change per year of exposure to each individual ART drug were determined using multivariate longitudinal regression. d4T and ZDV use was associated with losses in subcutaneous tissue area and skinfold thickness. 3TC use was associated with gains in all subcutaneous tissue areas and skinfold thickness, whereas abacavir use was associated with an increase in waist subcutaneous tissue area. Indinavir was associated with gains in waist subcutaneous tissue area, whereas indinavir, efavirenz, and nevirapine were associated with increases in upper back skinfolds. d4T use was also associated with increases in all nonsubcutaneous tissue areas; 3TC use was associated with the greatest increase in waist nonsubcutaneous tissue area. In this prospective nonrandomized evaluation, the nucleoside reverse transcriptase inhibitors d4T and ZDV were associated with decreases in subcutaneous tissue areas, whereas 3TC use was associated with increased subcutaneous tissue areas and waist nonsubcutaneous tissue area.

  9. Early antiretroviral therapy and potent second-line drugs could decrease HIV incidence of drug resistance.

    Science.gov (United States)

    Shen, Mingwang; Xiao, Yanni; Rong, Libin; Meyers, Lauren Ancel; Bellan, Steven E

    2017-06-28

    Early initiation of antiretroviral therapy (ART) reduces the risk of drug-sensitive HIV transmission but may increase the transmission of drug-resistant HIV. We used a mathematical model to estimate the long-term population-level benefits of ART and determine the scenarios under which earlier ART (treatment at 1 year post-infection, on average) could decrease simultaneously both total and drug-resistant HIV incidence (new infections). We constructed an infection-age-structured mathematical model that tracked the transmission rates over the course of infection and modelled the patients' life expectancy as a function of ART initiation timing. We fitted this model to the annual AIDS incidence and death data directly, and to resistance data and demographic data indirectly among men who have sex with men (MSM) in San Francisco. Using counterfactual scenarios, we assessed the impact on total and drug-resistant HIV incidence of ART initiation timing, frequency of acquired drug resistance, and second-line drug effectiveness (defined as the combination of resistance monitoring, biomedical drug efficacy and adherence). Earlier ART initiation could decrease the number of both total and drug-resistant HIV incidence when second-line drug effectiveness is sufficiently high (greater than 80%), but increase the proportion of new infections that are drug resistant. Thus, resistance may paradoxically appear to be increasing while actually decreasing. © 2017 The Author(s).

  10. Consumer Adoption of Counterfeit Products in a Developing Country

    NARCIS (Netherlands)

    M.M. Lede (Madesta)

    2013-01-01

    markdownabstract__Abstract__ With an increase in global trade, currently involving almost all countries in the world (expect for a few autarkic ones), there is a growing interest in studying various aspects of trade in counterfeit products. As almost every type of good has been counterfeited

  11. Detection of HIV drug resistance during antiretroviral treatment and clinical progression in a large European cohort study

    DEFF Research Database (Denmark)

    Cozzi-Lepri, Alessandro; Phillips, Andrew N; Clotet, Bonaventura

    2008-01-01

    OBJECTIVE(S): To investigate the relationship between detection of HIV drug resistance by 2 years from starting antiretroviral therapy and the subsequent risk of progression to AIDS and death. DESIGN: Virological failure was defined as experiencing two consecutive viral loads of more than 400...... copies/ml in the time window between 0.5 and 2 years from starting antiretroviral therapy (baseline). Patients were grouped according to evidence of virological failure and whether there was detection of the International AIDS Society resistance mutations to one, two or three drug classes in the time...... or death was 20.3% (95% CI:17.7-22.9) in patients with no evidence of virological failure and 53% (39.3-66.7) in those with virological failure and mutations to three drug classes (P = 0.0001). An almost two-fold difference in risk was confirmed in the multivariable analysis (adjusted relative hazard = 1...

  12. Dual antiretroviral therapy for HIV infection.

    Science.gov (United States)

    Soriano, Vicente; Fernandez-Montero, Jose Vicente; Benitez-Gutierrez, Laura; Mendoza, Carmen de; Arias, Ana; Barreiro, Pablo; Peña, José M; Labarga, Pablo

    2017-08-01

    For two decades, triple combinations of antiretrovirals have been the standard treatment for HIV infection. The challenges of such lifelong therapy include long-term side effects, high costs and reduced drug adherence. The recent advent of more potent and safer antiretrovirals has renewed the interest for simpler HIV regimens. Areas covered: We discuss the pros and cons of dual antiretroviral therapies in both drug-naïve and in treatment-experienced patients with viral suppression (switch strategy). Expert opinion: Some dual antiretroviral regimens are safe and efficacious, particularly as maintenance therapy. At this time, combinations of dolutegravir plus rilpivirine represent the best dual regimen. Longer follow-up and larger study populations are needed before supporting dolutegravir plus lamivudine. In contrast, dual therapy based on maraviroc is less effective. Although dual regimens with boosted protease inhibitors plus either lamivudine or raltegravir may be effective, they are penalized by metabolic side effects and risk for drug interactions. The newest dual regimens could save money, reduce toxicity and spare drug options for the future. For the first time in HIV therapeutics, less can be more. Dual therapy switching has set up a new paradigm in HIV treatment that uses induction-maintenance.

  13. Higgs friends and counterfeits at hadron colliders

    International Nuclear Information System (INIS)

    Fox, Patrick J.; Tucker-Smith, David; Weiner, Neal

    2011-01-01

    We consider the possibility of 'Higgs counterfeits' - scalars that can be produced with cross sections comparable to the SM Higgs, and which decay with identical relative observable branching ratios, but which are nonetheless not responsible for electroweak symmetry breaking. We also consider a related scenario involving 'Higgs friends,' fields similarly produced through gg fusion processes, which would be discovered through diboson channels WW,ZZ,γγ, or even γZ, potentially with larger cross sections times branching ratios than for the Higgs. The discovery of either a Higgs friend or a Higgs counterfeit, rather than directly pointing towards the origin of the weak scale, would indicate the presence of new colored fields necessary for the sizable production cross section (and possibly new colorless but electroweakly charged states as well, in the case of the diboson decays of a Higgs friend). These particles could easily be confused for an ordinary Higgs, perhaps with an additional generation to explain the different cross section, and we emphasize the importance of vector boson fusion as a channel to distinguish a Higgs counterfeit from a true Higgs. Such fields would naturally be expected in scenarios with 'effective Z's,' where heavy states charged under the SM produce effective charges for SM fields under a new gauge force. We discuss the prospects for discovery of Higgs counterfeits, Higgs friends, and associated charged fields at the LHC.

  14. Dynamics of counterfeit alcohol and tobacco goods in the Tatarstan Republic market

    Directory of Open Access Journals (Sweden)

    Oleg R. Karatayev

    2015-12-01

    Full Text Available Objective to identify and assess the share of counterfeit products in the total volume of alcohol and tobacco products in the consumer market of Tatarstan Republic which will allow the inspection bodies to deal more effectively to prevent the spreading of counterfeit products. Methods the research proposed in this paper used methods of probability theory and mathematical statistics and the method of sampling analysis of certificates for products in accordance with applicable laws and regulations of Rosstandart. Results basing on a sampling of certificates for products directly from retail outlets analysis of the state alcohol and tobacco consumer market of Tatarstan was carried out. Improper filling of the form of the certificate for products was identified violating all existing norms and laws which are strictly prescribed in technical regulations. On the basis of these violations the validity of certificates for products was assessed and the conclusion was made about the products quality. The share of counterfeit alcohol and tobacco products in the total sales in the consumer market was assessed. The shortcomings of the inspection authorities to detect counterfeit products were identified. Scientific novelty the consumer market was researched basing on the method of sampling using probability theory and mathematical statistics to estimate the share of counterfeit alcohol and tobacco products in the consumer market of Tatarstan. The error sampling for counterfeit products in the consumer market was defined. Practical significance the obtained results will allow the inspection authorities to better and more accurately identify counterfeit goods and to restrict the access of counterfeit alcohol and tobacco products to the consumer market of Tatarstan. It is necessary to strengthen the role of state regulation of commercial activities in the consumer market of Russia to stop the flow of counterfeit alcohol and tobacco products to the consumer

  15. Risk of myocardial infarction in patients with HIV infection exposed to specific individual antiretroviral drugs from the 3 major drug classes: the data collection on adverse events of anti-HIV drugs (D:A:D) study

    DEFF Research Database (Denmark)

    Worm, Signe Westring; Sabin, Caroline; Weber, Rainer

    2010-01-01

    BACKGROUND. The risk of myocardial infarction (MI) in patients with human immunodeficiency virus (HIV) infection has been assessed in 13 anti-HIV drugs in the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. METHODS. Poisson regression models were adjusted for cardiovascular risk...... factors, cohort, calendar year, and use of other antiretroviral drugs and assessed the association between MI risk and cumulative (per year) or recent (current or in the past 6 months) use of antiretroviral drugs, with >30,000 person-years of exposure. RESULTS. Over 178,835 person-years, 580 patients......% CI, 1.01-1.17], respectively) after adjustment for lipids but were not altered further after adjustment for other metabolic parameters. CONCLUSIONS. Of the drugs considered, only indinavir, lopinavir-ritonavir, didanosine, and abacavir were associated with a significantly increased risk of MI...

  16. Estimated glomerular filtration rate, chronic kidney disease and antiretroviral drug use in HIV-positive patients

    NARCIS (Netherlands)

    Mocroft, Amanda; Kirk, Ole; Reiss, Peter; de Wit, Stephane; Sedlacek, Dalibor; Beniowski, Marek; Gatell, Jose; Phillips, Andrew N.; Ledergerber, Bruno; Lundgren, Jens D.; Losso, M.; Elias, C.; Vetter, N.; Zangerle, R.; Karpov, I.; Vassilenko, A.; Mitsura, V. M.; Suetnov, O.; Clumeck, N.; Poll, B.; Colebunders, R.; Vandekerckhove, L.; Hadziosmanovic, V.; Kostov, K.; Begovac, J.; Machala, L.; Rozsypal, H.; Sedlacek, D.; Nielsen, J.; Kronborg, G.; Benfield, T.; Larsen, M.; Gerstoft, J.; Katzenstein, T.; Hansen, A.-B. E.; Skinhøj, P.; Pedersen, C.; Oestergaard, L.; Zilmer, K.; Smidt, Jelena; Ristola, M.; Katlama, C.; Viard, J.-P.; Girard, P.-M.; Livrozet, J. M.; Vanhems, P.; Pradier, C.; Dabis, F.; Neau, D.; Rockstroh, J.

    2010-01-01

    Objectives: Chronic kidney disease (CKD) in HIV-positive persons might be caused by both HIV and traditional or non-HIV-related factors. Our objective was to investigate long-term exposure to specific antiretroviral drugs and CKD. Design: A cohort study including 6843 HIV-positive persons with at

  17. Evolution of drug resistance in HIV-infected patients remaining on a virologically failing combination antiretroviral therapy regimen

    DEFF Research Database (Denmark)

    Cozzi-Lepri, Alessandro; Phillips, Andrew N; Ruiz, Lidia

    2007-01-01

    OBJECTIVE: To estimate the extent of drug resistance accumulation in patients kept on a virologically failing regimen and its determinants in the clinical setting. DESIGN: The study focused on 110 patients of EuroSIDA on an unchanged regimen who had two genotypic tests performed at two time points...... (t0 and t1) when viral load was > 400 copies/ml. METHODS: Accumulation of resistance between t0 and t1 was measured using genotypic susceptibility scores (GSS) obtained by counting the total number of active drugs (according to the Rega system v6.4.1) among all licensed antiretrovirals as of 1...... January 2006. Patients were grouped according to the number of active drugs in the failing regimen at t0 (GSS_f-t0). RESULTS: At t0, patients had been on the failing combination antiretroviral therapy (cART) for a median of 11 months (range, 6-50 months). Even patients with extensive resistance...

  18. The Determinants of Purchase Intention towards Counterfeit Mobile Phones in Pakistan

    OpenAIRE

    Muhammad Rizwan; Muhammad Nasir Jamal; Zain-Ul-Abidin; Khadeeja Gul Zareen; Arslan Khan; Barza Farhat; Rashid Khan

    2013-01-01

    The alarming emergence of global economic phenomenon of counterfeiting and the deficiency of research work in the context of consumer purchase intentions towards counterfeits makes the study more worthwhile than ever before. This study intends to examine the relationship of value consciousness, low price, past experience peer pressure and attitude on consumer purchase intentions in the context of counterfeit mobile phones in Pakistan. A sample of 329 students with the help of a questionnaire ...

  19. Combining overt and covert anti-counterfeiting technologies for securities

    Science.gov (United States)

    Uematsu, Tsuyoshi

    2006-02-01

    The National Printing Bureau of Japan has been developing new anti-counterfeiting technologies as a banknote printer. Some of our technologies have already been effectively introduced into Japan's new banknote series. Anti-counterfeiting technologies can be applied not only to banknotes but also to other security documents depending on desired features. In this presentation, I will introduce three of our newly developed overt and covert security techniques, which are intended for document security and brand protection, as well as banknotes. "Metallic View" is mainly for offset printing. "Copy Check" (micro-structural lines involving luminescence) is for plate making technology. "ImageSwitch" is for a new security solution which has unlimited printing applications. All three techniques create "latent images" (some of which may be better known as "carrier screen images") that are useful in preventing counterfeiting. While each of the techniques is effective by itself, all are more effective when applied together. Combining these techniques could make all security documents harder to copy using IT scanners, and provide cost-effective anti-counterfeiting solutions for all security users.

  20. Effectiveness and cost-effectiveness of potential responses to future high levels of transmitted HIV drug resistance in antiretroviral drug-naive populations beginning treatment

    DEFF Research Database (Denmark)

    Phillips, Andrew N; Cambiano, Valentina; Miners, Alec

    2014-01-01

    BACKGROUND: With continued roll-out of antiretroviral therapy (ART) in resource-limited settings, evidence is emerging of increasing levels of transmitted drug-resistant HIV. We aimed to compare the effectiveness and cost-effectiveness of different potential public health responses to substantial...

  1. Multimodal Theranostic Nanoformulations Permit Magnetic Resonance Bioimaging of Antiretroviral Drug Particle Tissue-Cell Biodistribution

    Science.gov (United States)

    Kevadiya, Bhavesh D.; Woldstad, Christopher; Ottemann, Brendan M.; Dash, Prasanta; Sajja, Balasrinivasa R.; Lamberty, Benjamin; Morsey, Brenda; Kocher, Ted; Dutta, Rinku; Bade, Aditya N.; Liu, Yutong; Callen, Shannon E.; Fox, Howard S.; Byrareddy, Siddappa N.; McMillan, JoEllyn M.; Bronich, Tatiana K.; Edagwa, Benson J.; Boska, Michael D.; Gendelman, Howard E.

    2018-01-01

    RATIONALE: Long-acting slow effective release antiretroviral therapy (LASER ART) was developed to improve patient regimen adherence, prevent new infections, and facilitate drug delivery to human immunodeficiency virus cell and tissue reservoirs. In an effort to facilitate LASER ART development, “multimodal imaging theranostic nanoprobes” were created. These allow combined bioimaging, drug pharmacokinetics and tissue biodistribution tests in animal models. METHODS: Europium (Eu3+)- doped cobalt ferrite (CF) dolutegravir (DTG)- loaded (EuCF-DTG) nanoparticles were synthesized then fully characterized based on their size, shape and stability. These were then used as platforms for nanoformulated drug biodistribution. RESULTS: Folic acid (FA) decoration of EuCF-DTG (FA-EuCF-DTG) nanoparticles facilitated macrophage targeting and sped drug entry across cell barriers. Macrophage uptake was higher for FA-EuCF-DTG than EuCF-DTG nanoparticles with relaxivities of r2 = 546 mM-1s-1 and r2 = 564 mM-1s-1 in saline, and r2 = 850 mM-1s-1 and r2 = 876 mM-1s-1 in cells, respectively. The values were ten or more times higher than what was observed for ultrasmall superparamagnetic iron oxide particles (r2 = 31.15 mM-1s-1 in saline) using identical iron concentrations. Drug particles were detected in macrophage Rab compartments by dual fluorescence labeling. Replicate particles elicited sustained antiretroviral responses. After parenteral injection of FA-EuCF-DTG and EuCF-DTG into rats and rhesus macaques, drug, iron and cobalt levels, measured by LC-MS/MS, magnetic resonance imaging, and ICP-MS were coordinate. CONCLUSION: We posit that these theranostic nanoprobes can assess LASER ART drug delivery and be used as part of a precision nanomedicine therapeutic strategy. PMID:29290806

  2. CROI 2016: Advances in Antiretroviral Therapy.

    Science.gov (United States)

    Taylor, Barbara S; Olender, Susan A; Tieu, Hong-Van; Wilkin, Timothy J

    2016-01-01

    The 2016 Conference on Retroviruses and Opportunistic Infections highlighted exciting advances in antiretroviral therapy, including important data on investigational antiretroviral drugs and clinical trials. Clinical trials demonstrated benefits from a long-acting injectable coformulation given as maintenance therapy, examined intravenous and subcutaneous administration of a monoclonal antibody directed at the CD4 binding site of HIV-1, and provided novel data on tenofovir alafenamide. Several studies focused on the role of HIV drug resistance, including the significance of minority variants, transmitted drug resistance, use of resistance testing, and drug class-related resistance. Novel data on the HIV care continuum in low- and middle-income settings concentrated on differentiated HIV care delivery models and outcomes. Data on progress toward reaching World Health Organization 90-90-90 targets as well as outcomes related to expedited initiation of HIV treatment and adherence strategies were presented. Results from a trial in Malawi showed reduced rates of mother-to-child transmission among HIV-infected women who initiated antiretroviral therapy prior to pregnancy, and several studies highlighted the effect of antiretroviral therapy in pediatric populations. A special session was dedicated to the findings of studies of Ebola virus disease and treatment during the outbreak in West Africa.

  3. The music of gold: can gold counterfeited coins be detected by ear?

    Science.gov (United States)

    Manas, Arnaud

    2015-07-01

    In this paper I investigate whether it is true and to what extent counterfeit coins can be detected by their sound frequency. I describe the different types of counterfeit coins encountered and their respective characteristics. I then use the Kirchoff thin plate theory to model a coin, and confirm the validity of the theory by listening to the tone of genuine and counterfeit coins.

  4. Testing of complementarity of PDA and MS detectors using chromatographic fingerprinting of genuine and counterfeit samples containing sildenafil citrate.

    Science.gov (United States)

    Custers, Deborah; Krakowska, Barbara; De Beer, Jacques O; Courselle, Patricia; Daszykowski, Michal; Apers, Sandra; Deconinck, Eric

    2016-02-01

    Counterfeit medicines are a global threat to public health. High amounts enter the European market, which is why characterization of these products is a very important issue. In this study, a high-performance liquid chromatography-photodiode array (HPLC-PDA) and high-performance liquid chromatography-mass spectrometry (HPLC-MS) method were developed for the analysis of genuine Viagra®, generic products of Viagra®, and counterfeit samples in order to obtain different types of fingerprints. These data were included in the chemometric data analysis, aiming to test whether PDA and MS are complementary detection techniques. The MS data comprise both MS1 and MS2 fingerprints; the PDA data consist of fingerprints measured at three different wavelengths, i.e., 254, 270, and 290 nm, and all possible combinations of these wavelengths. First, it was verified if both groups of fingerprints can discriminate between genuine, generic, and counterfeit medicines separately; next, it was studied if the obtained results could be ameliorated by combining both fingerprint types. This data analysis showed that MS1 does not provide suitable classification models since several genuines and generics are classified as counterfeits and vice versa. However, when analyzing the MS1_MS2 data in combination with partial least squares-discriminant analysis (PLS-DA), a perfect discrimination was obtained. When only using data measured at 254 nm, good classification models can be obtained by k nearest neighbors (kNN) and soft independent modelling of class analogy (SIMCA), which might be interesting for the characterization of counterfeit drugs in developing countries. However, in general, the combination of PDA and MS data (254 nm_MS1) is preferred due to less classification errors between the genuines/generics and counterfeits compared to PDA and MS data separately.

  5. Antiretroviral Drugs and Risk of Chronic Alanine Aminotransferase Elevation in Human Immunodeficiency Virus (HIV)-Monoinfected Persons

    DEFF Research Database (Denmark)

    Kovari, Helen; Sabin, Caroline A; Ledergerber, Bruno

    2016-01-01

    Background.  Although human immunodeficiency virus (HIV)-positive persons on antiretroviral therapy (ART) frequently have chronic liver enzyme elevation (cLEE), the underlying cause is often unclear. Methods.  Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study participants without ...

  6. Antiretroviral Resistance in HIV/AIDS Patients

    Science.gov (United States)

    Manosuthi, W.; MD

    2018-03-01

    The higher prevalence of HIV drug resistance was observed in areas with greater ART coverage. The HIV resistance-associated mutations occur when people have inadequate levels of antiretroviral drugs as well as inadequate potency, inadequate adherence, and preexisting resistance. The degree to drug cross-resistance is observed depends on the specific mutations and number of mutation accumulation. In the Southeast Asia region, the challenging of people with treatment failure is the availability and accessibility to subsequent new antiretroviral drugs to construct he second and salvage regimen. Genotypic resistance testing is a useful tool because it can identify the existing drug resistance-associated mutations under the selective drug pressure. Thus, understanding the basic interpretation of HIV drug resistance- associated mutation is useful in guiding clinical decisions for treatment-experienced people living with HIV.

  7. The location and recognition of anti-counterfeiting code image with complex background

    Science.gov (United States)

    Ni, Jing; Liu, Quan; Lou, Ping; Han, Ping

    2017-07-01

    The order of cigarette market is a key issue in the tobacco business system. The anti-counterfeiting code, as a kind of effective anti-counterfeiting technology, can identify counterfeit goods, and effectively maintain the normal order of market and consumers' rights and interests. There are complex backgrounds, light interference and other problems in the anti-counterfeiting code images obtained by the tobacco recognizer. To solve these problems, the paper proposes a locating method based on Susan operator, combined with sliding window and line scanning,. In order to reduce the interference of background and noise, we extract the red component of the image and convert the color image into gray image. For the confusing characters, recognition results correction based on the template matching method has been adopted to improve the recognition rate. In this method, the anti-counterfeiting code can be located and recognized correctly in the image with complex background. The experiment results show the effectiveness and feasibility of the approach.

  8. Counterfeit and Fraudulent Items - Mitigating the risk

    International Nuclear Information System (INIS)

    Tannenbaum, Marc

    2011-01-01

    This presentation (slides) provides an overview of the industry's challenges and activities. Firstly, it outlines the differences between counterfeit, fraudulent, suspect, and also substandard items. Notice is given that items could be found not to meet the standard, but the difference in the intent to deceive with counterfeit and fraudulent items is the critical element. Examples from other industries are used which also rely heavily on the assurance of quality for safety. It also informs that EPRI has just completed a report in October 2009 in coordination with other US government agencies and industry organizations; this report, entitled Counterfeit, Substandard and Fraudulent Items, number 1019163, is available for free on the EPRI web site. As a follow-up to this report, EPRI is developing a CFSI Database; any country interested in a collaborative agreement is invited to use and contribute to the database information. Finally, it stresses the importance of the oversight of contractors, training to raise the awareness of the employees and the inspectors, and having a response plan for identified items

  9. Microstructure-Based Counterfeit Detection in Metal Part Manufacturing

    Science.gov (United States)

    Dachowicz, Adam; Chaduvula, Siva Chaitanya; Atallah, Mikhail; Panchal, Jitesh H.

    2017-11-01

    Counterfeiting in metal part manufacturing has become a major global concern. Although significant effort has been made in detecting the implementation of such counterfeits, modern approaches suffer from high expense during production, invasiveness during manufacture, and unreliability in practice if parts are damaged during use. In this paper, a practical microstructure-based counterfeit detection methodology is proposed, which draws on inherent randomness present in the microstructure as a result of the manufacturing process. An optical Physically Unclonable Function (PUF) protocol is developed which takes a micrograph as input and outputs a compact, unique string representation of the micrograph. The uniqueness of the outputs and their robustness to moderate wear and tear is demonstrated by application of the methodology to brass samples. The protocol is shown to have good discriminatory power even between samples manufactured in the same batch, and runs on the order of several seconds per part on inexpensive machines.

  10. Simultaneous determination of antiretroviral drugs in human hair with liquid chromatography-electrospray ionization-tandem mass spectrometry.

    Science.gov (United States)

    Wu, Yan; Yang, Jin; Duan, Cailing; Chu, Liuxi; Chen, Shenghuo; Qiao, Shan; Li, Xiaoming; Deng, Huihua

    2018-04-15

    The determination of the concentrations of antiretroviral drugs in hair is believed to be an important means for the assessment of the long-term adherence to highly active antiretroviral therapy. At present, the combination of tenofovir, lamivudine and nevirapine is widely used in China. However, there was no research reporting simultaneous determination of the three drugs in hair. The present study aimed to develop a sensitive method for simultaneous determination of the three drugs in 2-mg and 10-mg natural hair (Method 1 and Method 2). Hair samples were incubated in methanol at 37 °C for 16 h after being rinsed with methanol twice. The analysis was performed on high performance liquid chromatography tandem mass spectrometry with electronic spray ionization in positive mode and multiple reactions monitoring. Method 1 and Method 2 showed the limits of detection at 160 and 30 pg/mg for tenofovir, at 5 and 6 pg/mg for lamivudine and at 15 and 3 pg/mg for nevirapine. The two methods showed good linearity with the square of correlation coefficient >0.99 at the ranges of 416-5000 and 77-5000 pg/mg for tenofovir, 12-5000 and 15-5000 pg/mg for lamivudine and 39-50,000 and 6-50,000 pg/mg for nevirapine. They gave intra-day and inter-day coefficient of variation <15% and the recoveries ranging from 80.6 to 122.3% and from 83.1 to 114.4%. Method 2 showed LOD and LOQ better than Method 1 for tenofovir and nevirapine and matched Method 1 for lamivudine, but there was high consistency between them in the determination of the three drugs in hair. The population analysis with Method 2 revealed that the concentrations in hair were decreased with the distance of hair segment away from the scalp for the three antiretroviral drugs. Copyright © 2018 Elsevier B.V. All rights reserved.

  11. Detection of counterfeit brand spirits using 1H NMR fingerprints in comparison to sensory analysis.

    Science.gov (United States)

    Kuballa, Thomas; Hausler, Thomas; Okaru, Alex O; Neufeld, Maria; Abuga, Kennedy O; Kibwage, Isaac O; Rehm, Jürgen; Luy, Burkhard; Walch, Stephan G; Lachenmeier, Dirk W

    2018-04-15

    Beverage fraud involving counterfeiting of brand spirits is an increasing problem not only due to deception of the consumer but also because it poses health risks e.g. from possible methanol admixture. Suspicious spirit samples from Russia and Kenya were analysed using 1 H nuclear magnetic resonance (NMR) spectroscopy in comparison to authentic products. Using linear regression analysis of spectral integral values, 4 counterfeited samples from Russia and 2 from Kenya were easily identifiable with R 2  counterfeited and authentic samples but the assessors were unable to correctly identify the counterfeited product in the majority of cases. An important conclusion is that consumers cannot assumed to be self-responsible when consuming counterfeit alcohol because there is no general ability to organoleptically detect counterfeit alcohol. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Lower genetic variability of HIV-1 and antiretroviral drug resistance in pregnant women from the state of Pará, Brazil.

    Science.gov (United States)

    Machado, Luiz Fernando Almeida; Costa, Iran Barros; Folha, Maria Nazaré; da Luz, Anderson Levy Bessa; Vallinoto, Antonio Carlos Rosário; Ishak, Ricardo; Ishak, Marluisa Oliveira Guimarães

    2017-04-12

    The present study aimed to describe the genetic diversity of HIV-1, as well as the resistance profile of the viruses identified in HIV-1 infected pregnant women under antiretroviral therapy in the state of Pará, Northern Brazil. Blood samples were collected from 45 HIV-1 infected pregnant to determine the virus subtypes according to the HIV-1 protease (PR) gene and part of the HIV-1 reverse transcriptase (RT) gene by sequencing the nucleotides of these regions. Drug resistance mutations and susceptibility to antiretroviral drugs were analyzed by the Stanford HIV Drug Resistance Database. Out of 45 samples, only 34 could be amplified for PR and 30 for RT. Regarding the PR gene, subtypes B (97.1%) and C (2.9%) were identified; for the RT gene, subtypes B (90.0%), F (6.7%), and C (3.3%) were detected. Resistance to protease inhibitors (PI) was identified in 5.8% of the pregnant, and mutations conferring resistance to nucleoside reverse transcriptase inhibitors were found in 3.3%, while mutations conferring resistance to non-nucleoside reverse transcriptase inhibitors were found in 3.3%. These results showed a low frequency of strains resistant to antiretroviral drugs, the prevalence of subtypes B and F, and the persistent low transmission of subtype C in pregnant of the state of Pará, Brazil.

  13. Multi-analytical approach for profiling some essential medical drugs

    International Nuclear Information System (INIS)

    Abubakar, M.

    2015-07-01

    Counterfeit and substandard pharmaceutical drugs are chiefly rampant in developing countries due to inadequate analytical facilities and lack of regulatory oversight. The production of counterfeit or substandard drugs is broadly problematic. Underestimating it therefore leads to morbidity, mortality, drug resistance, introduction of toxic substances into the body and loss of confidence in health care systems. Medical drugs that are often counterfeited range from antimalarial drugs to antiretroviral drugs with antibiotics being counterfeited the most. This research work, therefore, aims at contributing towards the establishment of measures/processes for distinguishing between fake and genuine amoxicillin drugs. This was achieved by the identification and quantification of the Active Pharmaceutical Ingredient (API) and the excipients in the drug formulation. The major analytical techniques employed for this research work were Instrumental Neutron Activation Analysis (INAA), X-ray Powder Diffraction (XRD), High Performance Liquid Chromatography (HPLC) and in vitro Dissolution Test. The amoxicillin samples analyzed were the foreign generic amoxicillin purchased from Ernest Chemists pharmacy at East Legon, Accra, the National Health Insurance Scheme (NHIS) amoxicillin purchased at Fair Mile pharmacy at West Legon, Accra and the Suspected Fake amoxicillin purchased at Okaishi market. For the establishment of fingerprint for identification of substandard amoxicillin, INAA was used to qualitatively determine the short lived radionuclides (excipients) which then facilitated the correct identification of the API and the excipient phases in each of the amoxicillin groups. The phases identified were Amoxicillin Trihydrate as the excipient, Magnesium Stearate (hydrated) and Magnesium Stearate (anhydrous) as the excipients. For Quality control purposes, High Performance Liquid Chromatography approach and also, the in vitro Dissolution test were conducted on each of the groups of

  14. Cutting the cost of South African antiretroviral therapy using newer, safer drugs

    Directory of Open Access Journals (Sweden)

    W F Venter

    2017-01-01

    Full Text Available Antiretrovirals are a significant cost driver for HIV programmes. Current first-line regimens have performed well in real-life programmes, but have a low barrier to virological resistance and still carry toxicity that limits adherence. New drug developments may mean that we have access to safer, more robust and cheaper regimens, but only if the appropriate clinical trials are conducted. We briefly discuss these trials, and demonstrate the large cost savings to the South African HIV programme if these are successful.

  15. [The role of German official medicines control laboratories in combating counterfeit medicines].

    Science.gov (United States)

    Wiegard, Andrea; Heuermann, Matthias

    2017-11-01

    An official medicines control laboratory (OMCL) provides an important contribution to combat counterfeit and illegal medicines. The OMCL supports the competent authorities in controlling the quality of authorised medicinal products in the legal supply chain. For detecting counterfeit medicines in the legal supply chain, a risk-based approach in choice of products is conducted. Furthermore, the OMCL analyses suspicious medicines from the illegal supply chain for any other authority. The chemical analysis of a suspicious sample is needed to identify such a sample as a counterfeit medicine. The analytical results are fundamental for the evaluation of the legal status of the product and for the assessment of it's inherent hazard to public health. The global market of illegal medicines is rapidly changing. Therefore a good national and international working liaison and co-operation between laboratories and authorities is obligatory to protect public health. The OMCL provides important knowledge of new trends in counterfeit and illegal medicines. Hence, it is an essential part in surveillance of medicinal products. The efficient networking enables prompt official interventions. Thus, risks for the public health by substandard medicines were reduced. Beside the chemical analysis, the OMCL can help to raise public awareness about counterfeit and illegal medicines. In Germany, the risk of counterfeit medicines reaching patients through the legal supply chain is still low, but the possibility cannot be ignored.

  16. [The fight against counterfeit medicines in Africa: experience and role of pharmacists].

    Science.gov (United States)

    Chauvé, Martine

    2008-12-01

    The counterfeiting of medicines is a global scourge, which is particularly serious in the African continent. According to WHO estimations, whereas counterfeit medicines represent 1% of the market in developed countries, up to 30% of the medicines sold in African countries are counterfeit. Several factors may explain this high rate in Africa, from the weaknesses of legislation and controls, to the lack of affordability of medicines and the attitude of governments. A counterfeit medicine represents different levels of risk, depending if the active substance is present or not, if the dosage is the right one, if the product contains toxic substances, etc. In Africa, several examples sadly showed the terrible impact the use of counterfeit medicines may have (i.e. Nigeria, 1990, Niger, 1995). Pharmacists have a crucial role to play in fighting against the penetration of counterfeit medicines, both in securing the distribution chain, and in leading some actions towards patients. The FIP has produced some guidelines on this issue by adopting a statement (which was last updated in 2003) and by providing pharmacists with useful tools on its website. Several international organizations such as the CIOPF (International conference of French-speaking Orders) produced recommendations on this issue. However, the experience and expertise gained by national organizations from countries such as Côte d'Ivoire are also worth sharing and are presented here.

  17. The Impact of Herbal Drug Use on Adverse Drug Reaction Profiles of Patients on Antiretroviral Therapy in Zimbabwe

    Directory of Open Access Journals (Sweden)

    Tinashe Mudzviti

    2012-01-01

    Full Text Available Background. The main objective was to determine the impact of herbal drug use on adverse drug reactions in patients on antiretroviral therapy (ART. Methodology. Patients receiving first-line ART from the national roll-out program participated in this cross-sectional study. Participants were interviewed and a data collection sheet was used to collect information from the corresponding medical record. Results. The majority (98.2% of participants were using at least one herbal drug together with ART. The most common herbal remedies used were Allium Sativum (72.7%, Bidens pilosa (66.0%, Eucalyptus globulus (52.3%, Moringa oleifera (44.1%, Lippia javanica (36.3%, and Peltoforum africanum (34.3%. Two indigenous herbs, Musakavakadzi (OR=0.25; 95% CI 0.076–0.828 and Peltoforum africanum (OR=0.495; 95% CI 0.292–0.839 reduced the occurrence of adverse drug events. Conclusions. The use of herbal drugs is high in the HIV-infected population and there is need for pharmacovigilance programs to recognize the role they play in altering ADR profiles.

  18. The counterfeit anti-malarial is a crime against humanity: a systematic review of the scientific evidence.

    Science.gov (United States)

    Karunamoorthi, Kaliyaperumal

    2014-06-02

    The counterfeiting of anti-malarials represents a form of attack on global public health in which fake and substandard anti-malarials serve as de facto weapons of mass destruction, particularly in resource-constrained endemic settings, where malaria causes nearly 660,000 preventable deaths and threatens millions of lives annually. It has been estimated that fake anti-malarials contribute to nearly 450,000 preventable deaths every year. This crime against humanity is often underestimated or ignored. This study attempts to describe and characterize the direct and indirect effects of counterfeit anti-malarials on public health, clinical care and socio-economic conditions. A search was performed using key databases, WHO documents, and English language search engines. Of 262 potential articles that were identified using a fixed set of criteria, a convenience sample of 105 appropriate articles was selected for this review. Artemisinin-based combination therapy (ACT) is an important tool in the fight against malaria, but a sizable number of patients are unable to afford to this first-line treatment. Consequently, patients tend to procure cheaper anti-malarials, which may be fake or substandard. Forensic palynology reveals that counterfeits originate in Asia. Fragile drug regulations, ineffective law-enforcement agencies and corruption further burden ailing healthcare facilities. Substandard/fake anti-malarials can cause (a) economic sabotage; (b) therapeutic failure; (c) increased risk of the emergence and spread of resistant strains of Plasmodium falciparum and Plasmodium vivax; (d) an undermining of trust/confidence in healthcare stakeholders/systems; and, (e) serious side effects or death. Combating counterfeit anti-malarials is a complex task due to limited resources and poor techniques for the detection and identification of fake anti-malarials. This situation calls for sustainable, global, scientific research and policy change. Further, responsible stakeholders in

  19. Adipocytes Impair Efficacy of Antiretroviral Therapy

    Science.gov (United States)

    Couturier, Jacob; Winchester, Lee C.; Suliburk, James W.; Wilkerson, Gregory K.; Podany, Anthony T.; Agarwal, Neeti; Chua, Corrine Ying Xuan; Nehete, Pramod N.; Nehete, Bharti P.; Grattoni, Alessandro; Sastry, K. Jagannadha; Fletcher, Courtney V.; Lake, Jordan E.; Balasubramanyan, Ashok; Lewis, Dorothy E.

    2018-01-01

    Adequate distribution of antiretroviral drugs to infected cells in HIV patients is critical for viral suppression. In humans and primates, HIV- and SIV-infected CD4 T cells in adipose tissues have recently been identified as reservoirs for infectious virus. To better characterize adipose tissue as a pharmacological sanctuary for HIV-infected cells, in vitro experiments were conducted to assess antiretroviral drug efficacy in the presence of adipocytes, and drug penetration in adipose tissue cells (stromal-vascular-fraction cells and mature adipocytes) was examined in treated humans and monkeys. Co-culture experiments between HIV-1-infected CD4 T cells and primary human adipocytes showed that adipocytes consistently reduced the antiviral efficacy of the nucleotide reverse transcriptase inhibitor tenofovir and its prodrug forms tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). In HIV-infected persons, LC-MS/MS analysis of intracellular lysates derived from adipose tissue stromal-vascular-fraction cells or mature adipocytes suggested that integrase inhibitors penetrate adipose tissue, whereas penetration of nucleoside/nucleotide reverse transcriptase inhibitors such as TDF, emtricitabine, abacavir, and lamivudine is restricted. The limited distribution and functions of key antiretroviral drugs within fat depots may contribute to viral persistence in adipose tissue. PMID:29630975

  20. Counterfeit Parts: DOD Needs to Improve Reporting and Oversight to Reduce Supply Chain Risk

    Science.gov (United States)

    2016-02-01

    agencies and contractors we met with stated that they have encountered counterfeit parts less frequently in the DOD supply chain , in part, because...the DOD supply chain as a method to prevent further counterfeiting.22 DOD and industry officials noted that timely reporting of...COUNTERFEIT PARTS DOD Needs to Improve Reporting and Oversight to Reduce Supply Chain Risk Report to Congressional Committees

  1. Surveillance of transmitted HIV drug resistance in antiretroviral-naive patients aged less than 25 years, in Bangkok, Thailand.

    Science.gov (United States)

    Sungkanuparph, Somnuek; Pasomsub, Ekawat; Chantratita, Wasun

    2014-01-01

    Emergence of transmitted HIV drug resistance (TDR) is a concern after global scale-up of antiretroviral therapy (ART). World Health Organization had developed threshold survey method for surveillance of TDR in resource-limited countries. ART in Thailand has been scaling up for >10 years. To evaluate the current TDR in Thailand, a cross-sectional study was conducted among antiretroviral-naive HIV-infected patients aged Thailand after a decade of rapid scale-up of ART. Interventions to prevent TDR at the population level are essentially needed in Thailand. Surveillance for TDR in Thailand has to be regularly performed.

  2. Counterfeits or Shanzhai? The Role of Face and Brand Consciousness in Luxury Copycat Consumption.

    Science.gov (United States)

    Jiang, Ling; Shan, Juan

    2016-08-01

    This study responds to the emergence of the Shanzhai phenomenon in the international marketplace and introduces the Shanzhai phenomenon into the consumer behavior literature by defining it and comparing it with well-known concepts like luxury counterfeits. More specifically, it examines how consumers' face and brand consciousness influence their willingness to buy luxury counterfeits rather than Shanzhai products. The results show that consumers who are more face conscious are more likely to choose luxury counterfeits than Shanzhai products. In addition, consumers' face consciousness elicits a high concern for well-known brands, which also in turn leads to a more favorable attitude toward luxury counterfeits than Shanzhai products. These findings enable researchers to better understand consumers' responses toward both Shanzhai and counterfeit products and help companies that are protecting their original brands to tailor their consumer-directed measures more effectively. © The Author(s) 2016.

  3. Platelet count kinetics following interruption of antiretroviral treatment

    DEFF Research Database (Denmark)

    Zetterberg, Eva; Neuhaus, Jacqueline; Baker, Jason V

    2013-01-01

    To investigate the mechanisms of platelet kinetics in the Strategies for Management of Antiretroviral Therapy (SMART) study that demonstrated excess mortality with CD4 guided episodic antiretroviral therapy (ART) drug conservation compared with continuous treatment viral suppression. Follow...

  4. Screening suspected counterfeit Viagra and imitations of Viagra with near-infrared spectroscopy.

    NARCIS (Netherlands)

    Vredenbregt, M J; Blok-Tip, L; Hoogerbrugge, Ronald; Barends, D M; Kaste, D de

    2006-01-01

    We describe a near-infrared spectroscopy (NIRS) method for fast-screening Viagra tablets, counterfeit Viagra tablets, and imitations of Viagra. The method can (1) check the homogeneity of a batch; (2) distinguish counterfeits and imitations from authentic Viagra; (3) screen for the presence of

  5. Treatment and prevention of HIV infection with long-acting antiretrovirals.

    Science.gov (United States)

    Benítez-Gutiérrez, Laura; Soriano, Vicente; Requena, Silvia; Arias, Ana; Barreiro, Pablo; de Mendoza, Carmen

    2018-05-01

    Current antiretroviral therapy allows to achieve and sustain maximal suppression of HIV replication in most treated patients. As result, the life expectancy of HIV-infected persons has improved dramatically and is nowadays similar to that of the HIV-negative population. However, oral antiretrovirals have to be taken daily and indefinitely to avoid resumption of HIV replication and selection of drug resistance. Unfortunately, drug adherence is often suboptimal and tends to decline over time. Areas covered: New drugs, formulations and delivery systems are being developed for extended-release of antiretrovirals. At this time, intramuscular cabotegravir and rilpivirine, dapivirine vaginal rings and tenofovir alafenamide subdermal implants are the products in more advanced stages of clinical development. Their pharmacokinetics/dynamics and safety/efficacy are reviewed. Expert commentary: In the absence of eradicative therapy for individuals with HIV infection and protective vaccines for persons at risk, long-term antiretroviral therapy is the best approach for preventing disease progression in patients and halting transmissions, either as result of 'treatment as prevention' for HIV carriers or 'pre-exposure prophylaxis' for uninfected individuals at risk. In all these scenarios, the advent of long-acting antiretrovirals will expand options for overcoming the challenge of suboptimal drug adherence and reduce the burden of HIV infection.

  6. The use of carbon stable isotope ratios in drugs characterization

    Energy Technology Data Exchange (ETDEWEB)

    Magdas, D. A., E-mail: gabriela.cristea@itim-cj.ro; Cristea, G., E-mail: gabriela.cristea@itim-cj.ro; Bot, A., E-mail: gabriela.cristea@itim-cj.ro; Mirel, V., E-mail: gabriela.cristea@itim-cj.ro [National Institute for Research and Development of Isotopic and Molecular Technologies, 65-103 Donath Str., 400293 Cluj-Napoca (Romania)

    2013-11-13

    Isotopic Ratio Mass Spectrometry (IRMS) is an effective toll to be used for drug product authentication. The isotopic composition could be used to assist in the differentiation between batches of drugs and assist in the identification of counterfeit materials on the market. Only two factors affect the isotopic ratios in pharmaceutical components: the isotopic composition of the raw materials and the synthetic processes performed upon them. Counterfeiting of pharmaceutical drugs threatens consumer confidence in drug products companies' economical well-being. In this preliminary study, the analyzed samples consist in two types of commercially available analgesics, which were purchases from Romanian pharmacies. Differences in δ{sup 13}C between batches from −29.7 to −31.6% were observed, demonstrating that this method can be used to differentiate among individual drug batches and subsequently identify counterfeits on the market. On the other hand, carbon isotopic ratios differences among producers were recorded, the variations being between −31.3 to −34.9% for the same type of analgesic, but from different manufactures.

  7. Current means for raising efficiency of counteraction to counterfeit goods trafficking

    Directory of Open Access Journals (Sweden)

    Dronova O.B.

    2014-12-01

    Full Text Available The urgency of counteraction to counterfeit goods trafficking is shown. Annual loss due to counterfeit goods producing and trafficking reaches several billion dollars. There remains a danger of buying low-quality and counterfeit goods despite implementing new producing techniques and protective elements. Measures, taken by law enforcement agencies, state authorities and public human rights organizations have not led to systematic suppression of producing and trafficking of such goods. Creation of new information and reference resource, containing information blocks of protective symbols on goods and packages and illustrated materials comprising patterns of discovered counterfeit goods, can assist to increase public awareness and to give necessary information to law enforcement agencies. Organizations, realizing state and social protection of consumers and entrepreneurs, along with producers, rightholders’ representatives and law enforcement bodies can accept the responsibility of creating and functioning this information and reference system in the Internet. Such level of cooperation of all interested organizations will allow to raise efficiency of measures for counteraction to trafficking goods with violated consumer properties. The author proves the necessity to organize functioning of information and reference resource for a wide range of users. Operation of such resource should comply with main principles of generating any information resource, notably full scale, authenticity and relevance of information. The author proposes the algorithm of creating such system which provides cooperation of law enforcement agencies, producers and consumers for the purpose of preventing counterfeit goods trafficking and investigating committed crimes.

  8. Interaction between pharmaceutical companies and physicians who prescribe antiretroviral drugs for treating AIDS

    Directory of Open Access Journals (Sweden)

    Mario Cesar Scheffer

    Full Text Available CONTEXT AND OBJECTIVE: Given that Brazil has a universal public policy for supplying medications to treat HIV and AIDS, the aim here was to describe the forms of relationship between physicians and the pharmaceutical companies that produce antiretrovirals (ARVs. DESIGN AND SETTING: Cross-sectional epidemiological study conducted in the state of São Paulo. METHODS : Secondary database linkage was used, with structured interviews conducted by telephone among a sample group of 300 physicians representing 2,361 professionals who care for patients with HIV and AIDS. RESULTS : Around two thirds (64% of the physicians prescribing ARVs for HIV and AIDS treatment in the state of São Paulo who were interviewed declared that they had some form of relationship with pharmaceutical companies, of which the most frequent were receipt of publications (54%, visits by sales promoters (51% and receipt of small-value objects (47%. CONCLUSIONS: Two forms of relationship between the pharmaceutical industry and physicians who deal with HIV and AIDS can be highlighted: facilitation of professionals' access to continuing education; and antiretroviral drug brand name promotion.

  9. Presence of Counterfeit Marlboro Gold Packs in Licensed Retail Stores in New York City: Evidence From Test Purchases.

    Science.gov (United States)

    Kurti, Marin; He, Yi; Silver, Diana; Giorgio, Margaret; von Lampe, Klaus; Macinko, James; Ye, Hua; Tan, Fidelis; Mei, Victoria

    2018-05-26

    There are no independent studies measuring the availability of premium brand counterfeit cigarettes in New York City from licensed retailers. We forensically analyzed the cigarette packaging of Marlboro Gold (n = 1021) purchased from licensed tobacco retailers in New York City, using ultraviolet irradiation and light microscopy to determine whether they were counterfeit. We find that while only 0.5% (n = 5) of our sample exhibits at least one characteristic synonymous with counterfeit packaging, none of our packs can be conclusively classified as counterfeit. We do not find any counterfeit Marlboro Gold packs purchased at full price from licensed cigarette retailers throughout New York City. Future research using test purchases should include other venues (eg, street and online) and specifically ask for discounts to ascertain the overall presence of counterfeit cigarettes. This is the first study to independently measure the availability of counterfeit cigarette packs purchased at full price from licensed retailers in New York City. We find that none of the Marlboro Gold packs purchased from licensed cigarette retailers are counterfeit.

  10. Drug resistance in HIV patients with virological failure or slow virological response to antiretroviral therapy in Ethiopia

    DEFF Research Database (Denmark)

    Abdissa, Alemseged; Yilma, Daniel; Fonager, Jannik

    2014-01-01

    BACKGROUND: The ongoing scale-up of antiretroviral therapy (ART) in sub-Saharan Africa has prompted the interest in surveillance of transmitted and acquired HIV drug resistance. Resistance data on virological failure and mutations in HIV infected populations initiating treatment in sub-Saharan Af...... mutations among failing patients justify increased vigilance by improving the availability and systematic use of VL testing to monitor ART response, and underlines the need for rapid, inexpensive tests to identify the most common drug resistance mutations....

  11. CONSPICUOUS CONSUMPTION, LUXURY PRODUCTS AND COUNTERFEIT MARKET IN THE UK

    OpenAIRE

    My Pham, TH; Nasir, M

    2016-01-01

    The fast growth of fashion brands and the popularity of counterfeit goods has posed certain challenges to the existing and new luxury fashion brand players. This study elaborates on the factors driving the market for counterfeit products in the UK. The data collected by means of survey questionnaires from 306 respondents and empirical techniques including descriptive and inferential statistics (correlation and multiple regression analysis), have shown that the consumers have a negative attitu...

  12. Consumption practices of counterfeit luxury goods in the Italian context

    OpenAIRE

    Giacomo Gistri; Simona Romani; Stefano Pace; Veronica Gabrielli; Silvia Grappi

    2009-01-01

    ABSTRACT Counterfeiting is an expanding and increasingly relevant phenomenon in contemporary markets that has a particular impact on luxury branded goods. Most academic literature to date has focused its attention on the determinants of purchase, underestimating the consumption phase. This paper aims to fi ll this gap by investigating how people consume counterfeit luxury products. Our results help us to better understand the phenomenon as a whole, with the objective of prov...

  13. ATR-FTIR for rapid detection and quantification of counterfeit medicines

    OpenAIRE

    Ogwu, John; Lawson, Graham; Tanna, Sangeeta

    2015-01-01

    From therapeutic to lifestyle medicines, the counterfeiting of medicines has been on the rise in recent times [1]. Estimates indicate that about 10% of medicines worldwide are counterfeits with much higher figures in developing countries [2]. Currently, the rapid screening of medicines is a challenge leaving many patients at risk [1]. This study considered the potential use of Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy (ATR-FTIR) for rapid quantitative analysis of ta...

  14. New targets and novel antiretrovirals | Wood | Southern African ...

    African Journals Online (AJOL)

    Highly active antiretroviral therapy (HAART) has to date been based on use of a triple combination of drugs chosen from three classes of antiretrovirals (ARVs), nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). These ARV classes ...

  15. THE ANALYSIS OF COUNTERFEITING FOOD PRODUCTS

    Directory of Open Access Journals (Sweden)

    Paula - Angela VIDRASCU

    2013-12-01

    Full Text Available The issue addressed in this paper makes a significant contribution to research on the effects that food tampering has at the expense of consumer health. Nowadays quality and food safety that consumers are entitled directly reflects the quality of life. In other words the present subject is of particular importance to the work of the bodies created for the purpose of protecting the health and quality of life of consumers. This study has an important role both in the short and long term through proper understanding of the terms of quality, adulteration and food safety. The essential aim of this article is played understanding and easy identification of counterfeit food. Thus the awareness of counterfeit food products consumers are becoming more aware and responsible on quality of life. Quality will always be one of the most important competitive factors of ensuring health and environmental protection.

  16. Prediction of phenotypic susceptibility to antiretroviral drugs using physiochemical properties of the primary enzymatic structure combined with artificial neural networks

    DEFF Research Database (Denmark)

    Kjaer, J; Høj, L; Fox, Z

    2008-01-01

    OBJECTIVES: Genotypic interpretation systems extrapolate observed associations in datasets to predict viral susceptibility to antiretroviral drugs (ARVs) for given isolates. We aimed to develop and validate an approach using artificial neural networks (ANNs) that employ descriptors...

  17. CD4+ Count-Guided Interruption of Antiretroviral Treatment. The Strategies for Mangement of Antiretroviral Therapy (SMART) Study Group

    DEFF Research Database (Denmark)

    El-Sadr, WM; Lundgren, Jens Dilling; Neaton, JD

    2006-01-01

    had a CD4+ cell count of more than 350 per cubic millimeter to the continuous use of antiretroviral therapy (the viral suppression group) or the episodic use of antiretroviral therapy (the drug conservation group). Episodic use involved the deferral of therapy until the CD4+ count decreased to less......BACKGROUND: Despite declines in morbidity and mortality with the use of combination antiretroviral therapy, its effectiveness is limited by adverse events, problems with adherence, and resistance of the human immunodeficiency virus (HIV). METHODS: We randomly assigned persons infected with HIV who...... the risk of adverse events that have been associated with antiretroviral therapy. (ClinicalTrials.gov number, NCT00027352 [ClinicalTrials.gov].). Copyright 2006 Massachusetts Medical Society....

  18. Perfume fingerprinting by easy ambient sonic-spray ionization mass spectrometry: nearly instantaneous typification and counterfeit detection.

    Science.gov (United States)

    Haddad, Renato; Catharino, Rodrigo Ramos; Marques, Lygia Azevedo; Eberlin, Marcos Nogueira

    2008-11-01

    Perfume counterfeiting is an illegal worldwide practice that involves huge economic losses and potential consumer risk. EASI is a simple, easily performed and rapidly implemented desorption/ionization technique for ambient mass spectrometry (MS). Herein we demonstrate that EASI-MS allows nearly instantaneous perfume typification and counterfeit detection. Samples are simply sprayed onto a glass rod or paper surface and, after a few seconds of ambient drying, a profile of the most polar components of the perfume is acquired. These components provide unique and reproducible chemical signatures for authentic perfume samples. Counterfeiting is readily recognized since the exact set and relative proportions of the more polar chemicals, sometimes at low concentrations, are unknown or hard to reproduce by the counterfeiters and hence very distinct and variable EASI-MS profiles are observed for the counterfeit samples.

  19. 31 CFR 101.4 - Extraction of gold bullion from the counterfeit coins.

    Science.gov (United States)

    2010-07-01

    ... 31 Money and Finance: Treasury 1 2010-07-01 2010-07-01 false Extraction of gold bullion from the... MITIGATION OF FORFEITURE OF COUNTERFEIT GOLD COINS § 101.4 Extraction of gold bullion from the counterfeit... Bureau of the Mint where, if economically feasible, the gold bullion will be extracted from the...

  20. Substandard and Counterfeit Antimicrobials: Recent Trends and ...

    African Journals Online (AJOL)

    ... trends in the availability of substandard and counterfeit antimicrobials in the global market ... Literature search using PubMed and Medline databases and Google search engine was conducted to identify related publications on the subject.

  1. Efek Samping Obat terhadap Kepatuhan Pengobatan Antiretroviral Orang dengan HIV/AIDS

    Directory of Open Access Journals (Sweden)

    Fachri Latif

    2014-12-01

    Full Text Available Tingkat kepatuhan pengobatan antiretroviral di Indonesia sangat rendah, yaitu 40 - 70%, yang masih di bawah target nasional dengan tingkat kepatuhan 95%. Berbeda dengan rata-rata nasional, Puskesmas Jumpandang Baru justru memiliki tingkat kepatuhan pengobatan antiretroviral pasien HIV/AIDS di atas 95%. Penelitian ini bertujuan untuk menganalisis faktor yang paling berpengaruh terhadap kepatuhan pengobatan antiretroviral orang dengan HIV/AIDS (ODHA. Jenis penelitian bersifat observasional analitik dengan pendekatan potong lintang. Populasi penelitian adalah 121 ODHA yang aktif menjalani pengobatan antiretroviral di Puskesmas Jumpandang Baru yang dipilih dengan menggunakan teknik exhaustive sampling. Sampel dalam penelitian ini adalah 121 sampel. Penelitian dilakukan pada 22 April hingga 28 Juni 2014 di klinik Voluntary Counseling and Test Puskesmas Jumpandang Baru Makassar. Analisis data menggunakan uji kai kuadrat dan regresi logistik. Hasil uji kai kuadrat menunjukkan ada hubungan antara pengetahuan, persepsi, riwayat efek samping obat, dukungan keluarga dan teman, serta interaksi antara pasien dengan petugas layanan antiretroviral terhadap kepatuhan pengobatan antiretroviral ODHA. Analisis regresi logistik menunjukan bahwa pengetahuan yang baik, persepsi positif terhadap pengobatan, serta efek samping obat yang tidak dirasakan adalah faktor yang berhubungan dengan kepatuhan pengobatan antiretroviral. Penelitian ini menunjukkan ODHA yang tidak merasakan efek samping obat memiliki kecenderungan terbesar untuk patuh terhadap pengobatan antiretroviral dengan OR sebesar 13,452. Drug Side Effects on Adherence to Antiretroviral Treatment among People Living with HIV/AIDS The rate of adherence to antiretroviral treatment in Indonesia is very low, at 40 - 70%, which is still below our national target (95%. Different phenomena happens at Jumpandang Baru Primary Health Care, whose level of antiretroviral treatment adherence above 95%. This study aimed to

  2. HIV drug resistance early warning indicators in cohorts of individuals starting antiretroviral therapy between 2004 and 2009: World Health Organization global report from 50 countries.

    Science.gov (United States)

    Bennett, Diane E; Jordan, Michael R; Bertagnolio, Silvia; Hong, Steven Y; Ravasi, Giovanni; McMahon, James H; Saadani, Ahmed; Kelley, Karen F

    2012-05-01

    The World Health Organization developed a set of human immunodeficiency virus drug resistance (HIVDR) early warning indicators (EWIs) to assess antiretroviral therapy clinic and program factors associated with HIVDR. EWIs are monitored by abstracting data routinely recorded in clinical records, and the results enable clinics and program managers to identify problems that should be addressed to minimize preventable emergence of HIVDR in clinic populations. As of June 2011, 50 countries monitored EWIs, covering 131 686 patients initiating antiretroviral treatment between 2004 and 2009 at 2107 clinics. HIVDR prevention is associated with patient care (appropriate prescribing and patient monitoring), patient behavior (adherence), and clinic/program management efforts to reduce treatment interruptions (follow up, retention on first-line ART, procurement and supply management of antiretroviral drugs). EWIs measure these factors and the results have been used to optimize patient and population treatment outcomes.

  3. Suspect/Counterfeit Items Information Guide for Subcontractors/Suppliers

    Energy Technology Data Exchange (ETDEWEB)

    Tessmar, Nancy D. [Los Alamos National Laboratory; Salazar, Michael J. [Los Alamos National Laboratory

    2012-09-18

    Counterfeiting of industrial and commercial grade items is an international problem that places worker safety, program objectives, expensive equipment, and security at risk. In order to prevent the introduction of Suspect/Counterfeit Items (S/CI), this information sheet is being made available as a guide to assist in the implementation of S/CI awareness and controls, in conjunction with subcontractor's/supplier's quality assurance programs. When it comes to counterfeit goods, including industrial materials, items, and equipment, no market is immune. Some manufactures have been known to misrepresent their products and intentionally use inferior materials and processes to manufacture substandard items, whose properties can significantly cart from established standards and specifications. These substandard items termed by the Department of Energy (DOE) as S/CI, pose immediate and potential threats to the safety of DOE and contractor workers, the public, and the environment. Failure of certain systems and processes caused by an S/CI could also have national security implications at Los Alamos National Laboratory (LANL). Nuclear Safety Rules (federal Laws), DOE Orders, and other regulations set forth requirements for DOE contractors to implement effective controls to assure that items and services meet specified requirements. This includes techniques to implement and thereby minimizing the potential threat of entry of S/CI to LANL. As a qualified supplier of goods or services to the LANL, your company will be required to establish and maintain effective controls to prevent the introduction of S/CI to LANL. This will require that your company warrant that all items (including their subassemblies, components, and parts) sold to LANL are genuine (i.e. not counterfeit), new, and unused, and conform to the requirements of the LANL purchase orders/contracts unless otherwise approved in writing to the Los Alamos National Security (LANS) contract administrator

  4. Guidelines for identifying suspect/counterfeit material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-09-01

    These guidelines are intended to assist users of products in identifying: substandard, misrepresented, or fraudulently marked items. The guidelines provide information about such topics as: precautions, inspection and testing, dispositioning identified items, installed inspection and reporting suspect/counterfeit materials. These guidelines apply to users who are developing procurement documents, product acceptance/verification methods, company procedures, work instructions, etc. The intent of these SM guidelines in relation to the Quality Assurance Program Description (QAPD) and implementing company Management Control Procedures is not to substitute or replace existing requirements, as defined in either the QAPD or company implementing instructions (Management Control Procedures). Instead, the guidelines are intended to provide a consolidated source of information addressing the issue of Suspect/Counterfeit materials. These guidelines provide an extensive suspect component listing and suspect indications listing. Users can quickly check their suspect items against the list of manufacturers products (i.e., type, LD. number, and nameplate information) by consulting either of these listings.

  5. Insulin resistance induced by antiretroviral drugs: Current ...

    African Journals Online (AJOL)

    Treatment with highly active antiretroviral therapy (HAART) has improved the prognosis of patients with AIDS, but it has also increased the incidence of various metabolic disorders, in particular insulin resistance accompanied by dyslipidaemia, hyperglycaemia and lipodystrophy. This is often accompanied by frank type 2 ...

  6. Hidden costs of HIV treatment in Spain: inefficiency of the antiretroviral drug packaging.

    Science.gov (United States)

    Llibre-Codina, Josep M; Andreu-Crespo, Angels; Cardona-Peitx, Gloria; Sala-Piñol, Ferran; Clotet-Sala, Bonaventura; Bonafont-Pujol, Xavier

    2014-01-01

    Antiretroviral drugs in Spain are delivered by law only in hospital pharmacies. Commercial packages meet variable quality standards when dispensed drugs are returned due to treatment changes or adherence problems Nearly 20-25% of the initial regimens will be changed at 48 weeks for different reasons. We evaluated the economic impact on public health system of the inability of using returned drugs due to inefficient packaging. We defined socially efficient packaging as the best adapted one to being delivered in unit dose to outpatients and classified: Class A - Drug packed in unit doses with complete info (name of drug, dosage in mg, lot, and expiring date) in each unit, maintaining complete information of the drug if returned when the external package is opened. Class B - packed in blisters with complete info in the blister, but not in unit doses, without special conservation conditions (should be re-packed in unit doses in the pharmacy before its dispensation to assure a class A excellence). Class C - packed in plastic containers with complete info written only on a label over the container, would allow repackaging only before its initial delivery, but not when returned. Class D - drug packed in plastic containers with manufacturer's warning that the product cannot be placed outside of the original package due to special conditions of conservation (fridge, humidity) that doesn't allow a unit dose repackaging or reusing an opened container. We analysed a 12-month period (July 2011-June 2012) in a hospital-based HIV outpatient pharmacy that serves 2413 treated individuals. Patients generated 23,574 visits to pharmacy, and received 48,325 drug packages, with 2.529.137 pills delivered. The patients suffered 1051 treatment changes for any reason. A total amount of 122.945€ in treatment were returned to pharmacy in opened packages during the study period. 47.139.91€ would be totally lost, mainly due to being packaged in class C and D boxes, the equivalent of

  7. Prevalence of drug resistance and importance of viral load measurements in Honduran HIV-infected patients failing antiretroviral treatment.

    Science.gov (United States)

    Murillo, Wendy; de Rivera, I L; Parham, L; Jovel, E; Palou, E; Karlsson, A C; Albert, J

    2010-02-01

    The Honduran HIV/AIDS Program began to scale up access to HIV therapy in 2002. Up to May 2008, more than 6000 patients received combination antiretroviral therapy (cART). As HIV drug resistance is the major obstacle for effective treatment, the purpose of this study was to assess the prevalence of antiretroviral drug resistance in Honduran HIV-1-infected individuals. We collected samples from 138 individuals (97 adults and 41 children) on cART with virological, immunological or clinical signs of treatment failure. HIV-1 pol sequences were obtained using an in-house method. Resistance mutations were identified according to the 2007 International AIDS Society (IAS)-USA list and predicted susceptibility to cART was scored using the ANRS algorithm. Resistance mutations were detected in 112 patients (81%), 74% in adults and 98% in children. Triple-, dual- and single-class drug resistance was documented in 27%, 43% and 11% of the study subjects, respectively. Multiple logistic regression showed that resistance was independently associated with type of treatment failure [virological failure (odds ratio (OR) = 1) vs. immunological failure (OR = 0.11; 95% confidence interval (CI) 0.030-0.43) vs. clinical failure (OR = 0.037; 95% CI 0.0063-0.22)], route of transmission (OR = 42.8; 95% CI 3.73-491), and years on therapy (OR = 1.81; 95% CI 1.11-2.93). The prevalence of antiretroviral resistance was high in Honduran HIV-infected patients with signs of treatment failure. A majority of study subjects showed dual- or triple-class resistance to nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors and protease inhibitors. Virologically defined treatment failure was a strong predictor of resistance, indicating that viral load testing is needed to correctly identify patients with treatment failure attributable to resistance.

  8. Nurses' perceptions about Botswana patients' anti-retroviral therapy ...

    African Journals Online (AJOL)

    Anti-retroviral drugs(ARVs) are supplied free of charge in Botswana. Lifelong adherence to antiretroviral therapy (ART) is vital to improve the patient's state of well-being and to prevent the development of strains of the human immunodefi ciency virus (HIV) that are resistant to ART. Persons with ART-resistant strains of HIV ...

  9. Avoid Counterfeit Pesticide Products for Dogs and Cats

    Science.gov (United States)

    EPA is aware of counterfeit pet pesticides designed to look like legitimately registered pesticide products. The information on this page is intended to help consumers avoid unregistered pet products.

  10. Identification of Counterfeit Alcoholic Beverages Using Cluster Analysis in Principal-Component Space

    Science.gov (United States)

    Khodasevich, M. A.; Sinitsyn, G. V.; Gres'ko, M. A.; Dolya, V. M.; Rogovaya, M. V.; Kazberuk, A. V.

    2017-07-01

    A study of 153 brands of commercial vodka products showed that counterfeit samples could be identified by introducing a unified additive at the minimum concentration acceptable for instrumental detection and multivariate analysis of UV-Vis transmission spectra. Counterfeit products were detected with 100% probability by using hierarchical cluster analysis or the C-means method in two-dimensional principal-component space.

  11. Trick or Treat? An Examination of Marketing Relationships in a Nondeceptive Counterfeit Market

    Science.gov (United States)

    Xiao, Sarah Hong; Nicholson, Michael

    2010-01-01

    Who is most responsible for the proliferation of counterfeit goods--the illicit purveyor of such products or the consumer who procures them? This paper seeks to address this question by presenting a behavior analysis of counterfeit marketing firms in China and the interdependent relationships between legitimate retailers, consumers, and the…

  12. Surveillance of transmitted antiretroviral drug resistance among HIV-1 infected women attending antenatal clinics in Chitungwiza, Zimbabwe.

    Directory of Open Access Journals (Sweden)

    Mqondisi Tshabalala

    Full Text Available The rapid scale-up of highly active antiretroviral therapy (HAART and use of single dose Nevirapine (SD NVP for prevention of mother-to-child transmission (pMTCT have raised fears about the emergence of resistance to the first line antiretroviral drug regimens. A cross-sectional study was conducted to determine the prevalence of primary drug resistance (PDR in a cohort of young (<25 yrs HAART-naïve HIV pregnant women attending antenatal clinics in Chitungwiza, Zimbabwe. Whole blood was collected in EDTA for CD4 counts, viral load, serological estimation of duration of infection using the BED Calypte assay and genotyping for drug resistance. Four hundred and seventy-one women, mean age 21 years; SD: 2.1 were enrolled into the study between 2006 and 2007. Their median CD4 count was 371cells/µL; IQR: 255-511 cells/µL. Two hundred and thirty-six samples were genotyped for drug resistance. Based on the BED assay, 27% were recently infected (RI whilst 73% had long-term infection (LTI. Median CD4 count was higher (p<0.05 in RI than in women with LTI. Only 2 women had drug resistance mutations; protease I85V and reverse transcriptase Y181C. Prevalence of PDR in Chitungwiza, 4 years after commencement of the national ART program remained below WHO threshold limit (5%. Frequency of recent infection BED testing is consistent with high HIV acquisition during pregnancy. With the scale-up of long-term ART programs, maintenance of proper prescribing practices, continuous monitoring of patients and reinforcement of adherence may prevent the acquisition and transmission of PDR.

  13. Derivative Spectrophotometric Method for Estimation of Antiretroviral Drugs in Fixed Dose Combinations

    Science.gov (United States)

    P.B., Mohite; R.B., Pandhare; S.G., Khanage

    2012-01-01

    Purpose: Lamivudine is cytosine and zidovudine is cytidine and is used as an antiretroviral agents. Both drugs are available in tablet dosage forms with a dose of 150 mg for LAM and 300 mg ZID respectively. Method: The method employed is based on first order derivative spectroscopy. Wavelengths 279 nm and 300 nm were selected for the estimation of the Lamovudine and Zidovudine respectively by taking the first order derivative spectra. The conc. of both drugs was determined by proposed method. The results of analysis have been validated statistically and by recovery studies as per ICH guidelines. Result: Both the drugs obey Beer’s law in the concentration range 10-50 μg mL-1,for LAM and ZID; with regression 0.9998 and 0.9999, intercept – 0.0677 and – 0.0043 and slope 0.0457 and 0.0391 for LAM and ZID, respectively.The accuracy and reproducibility results are close to 100% with 2% RSD. Conclusion: A simple, accurate, precise, sensitive and economical procedures for simultaneous estimation of Lamovudine and Zidovudine in tablet dosage form have been developed. PMID:24312779

  14. NFC based Inspection and Qualification Management (NIQM) System Preventing Counterfeit and Fraudulent Item

    International Nuclear Information System (INIS)

    Chang, Choong Koo; Kim, Young Joo

    2013-01-01

    Design, manufacturing, fabrication, transportation and installation of the devices and equipment for nuclear power plants shall be conducted under the thorough quality assurance program for the nuclear safety. However, from late in the 1980s, NRC began to issue a number of communications alerting licenses to issues involving counterfeit and fraudulent items. A number of incidents identified by the NRC in the 1980s and 1990s catalyzed the US nuclear industry to adopt standard precautions to guard against counterfeit items. The purpose of this paper is to develop the NFC (Near Field Communication) based Inspection and Qualification Management(NIQM) system preventing counterfeit and fraudulent items. NFC is one of the latest wireless communication technologies. As a short-range wireless connectivity technology, NFC offers safe-yet simple and intuitive-communication between electronic devices. As described above, NFC technology can be applied to the inspection and qualification management system very effectively to prevent counterfeit and fraudulent items. In addition, NIQM system can use existing data and information through the interface with legacy system

  15. NFC based Inspection and Qualification Management (NIQM) System Preventing Counterfeit and Fraudulent Item

    Energy Technology Data Exchange (ETDEWEB)

    Chang, Choong Koo; Kim, Young Joo [KEPCO International Nuclear Graduate School, Ulsan (Korea, Republic of)

    2013-10-15

    Design, manufacturing, fabrication, transportation and installation of the devices and equipment for nuclear power plants shall be conducted under the thorough quality assurance program for the nuclear safety. However, from late in the 1980s, NRC began to issue a number of communications alerting licenses to issues involving counterfeit and fraudulent items. A number of incidents identified by the NRC in the 1980s and 1990s catalyzed the US nuclear industry to adopt standard precautions to guard against counterfeit items. The purpose of this paper is to develop the NFC (Near Field Communication) based Inspection and Qualification Management(NIQM) system preventing counterfeit and fraudulent items. NFC is one of the latest wireless communication technologies. As a short-range wireless connectivity technology, NFC offers safe-yet simple and intuitive-communication between electronic devices. As described above, NFC technology can be applied to the inspection and qualification management system very effectively to prevent counterfeit and fraudulent items. In addition, NIQM system can use existing data and information through the interface with legacy system.

  16. Identifying a common origin of toner printed counterfeit banknotes by micro-Raman spectroscopy.

    Science.gov (United States)

    Skenderović Božičević, Martina; Gajović, Andreja; Zjakić, Igor

    2012-11-30

    This study explores the applicability of micro-Raman spectroscopy as a non-destructive technique for the analysis of color toner printed counterfeits. The main aim of the research paper was to find out whether Raman spectroscopy is a suitable method for establishing the connection between different specimens of counterfeits suspected to be printed with the same toner on the same machine. Specimens of different types of toners printed on different types of paper are analyzed by means of the micro-Raman spectroscopy system with the excitation line at 514.5 nm. For each specimen cyan, magenta and yellow toners are analyzed separately. The yellow toners displayed the most distinctive Raman spectra. The results show that micro-Raman spectroscopy can be successfully applied as a method for the analysis of color toner printed counterfeits, such as banknotes and documents, in order to establish links between more or less different specimens of counterfeits by measuring the properties of a color toner. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  17. Counterfeit Parts Prevention Strategies Guide

    Science.gov (United States)

    2014-06-24

    requirements of 252.211-7003, Item Unique Identification and Valuation .” This section establishes a recommended approach for requirements, polices, and...7003 Item Unique Identification and Valuation DoDI 4140.67 DoD Counterfeit Prevention Policy DoDI 5200.39 Critical Program Information (CPI...Deborah Valley deborah.valley@ll.mit.edu MIT Fred Van Milligen fvanmilligen@jdsu.com JDSU Marvin VanderWeg marvin.vanderwag@spacex.c om SpaceX Gerrit

  18. Challenges in Initiating Antiretroviral Therapy in 2010

    Directory of Open Access Journals (Sweden)

    Cécile L Tremblay

    2010-01-01

    Full Text Available Many clinical trials have shown that initiating antiretroviral therapy (ART at higher rather than lower CD4 T cell-positive counts results in survival benefit. Early treatment can help prevent end-organ damage associated with HIV replication and can decrease infectivity. The mainstay of treatment is either a non-nucleoside reverse transcriptase inhibitor or a ritonavir-boosted protease inhibitor in combination with two nucleoside reverse transcriptase inhibitors. While effective at combating HIV, ART can produce adverse alterations of lipid parameters, with some studies suggesting a relationship between some anti-retroviral agents and cardiovascular disease. As the HIV-positive population ages, issues such as hypertension and diabetes must be taken into account when initiating ART. Adhering to ART can be difficult; however, nonoptimal adherence to ART can result in the development of resistance; thus, drug characteristics and the patient’s preparedness to begin therapy must be considered. Reducing the pill burden through the use of fixed-dose antiretroviral drug combinations can facilitate adherence.

  19. IN IDENTIFYING FAKE AND SUBSTANDARD DRUGS IN NIGERIA ...

    African Journals Online (AJOL)

    user

    2017-07-01

    Jul 1, 2017 ... The high prevalence of counterfeit medicines particularly anti-malaria ... ofMobile Authentication Service (MAS) put the power of fake drugs .... In Nigeria today, it is common knowledge that drugs are treated as general ...

  20. Patterns of HIV-1 Drug Resistance After First-Line Antiretroviral Therapy (ART) Failure in 6 Sub-Saharan African Countries: Implications for Second-Line ART Strategies

    NARCIS (Netherlands)

    Hamers, Raph L.; Sigaloff, Kim C. E.; Wensing, Annemarie M.; Wallis, Carole L.; Kityo, Cissy; Siwale, Margaret; Mandaliya, Kishor; Ive, Prudence; Botes, Mariette E.; Wellington, Maureen; Osibogun, Akin; Stevens, Wendy S.; Rinke de Wit, Tobias F.; Schuurman, Rob; Siwale, M.; Njovu, C.; Labib, M.; Menke, J.; Botes, M. E.; Conradie, F.; Ive, P.; Sanne, I.; Wallis, C. L.; Letsoalo, E.; Stevens, W. S.; Hardman, M.; Wellington, M.; Luthy, R.; Mandaliya, K.; Abdallah, S.; Jao, I.; Dolan, M.; Namayanja, G.; Nakatudde, L.; Nankya, I.; Kiconco, M.; Abwola, M.; Mugyenyi, P.; Osibogun, A.; Akanmu, S.; Schuurman, R.; Wensing, A. M.; Straatsma, E.; Wit, F. W.; Dekker, J.; van Vugt, M.; Lange, J. M.

    2012-01-01

    Background. Human immunodeficiency virus type 1 (HIV-1) drug resistance may limit the benefits of antiretroviral therapy (ART). This cohort study examined patterns of drug-resistance mutations (DRMs) in individuals with virological failure on first-line ART at 13 clinical sites in 6 African

  1. Antiretroviral Drug Resistance- implications for HIV/AIDS reduction ...

    African Journals Online (AJOL)

    Saharan Africa and other developing countries. ... Abstract: Background: The introduction of the highly active antiretroviral therapy in the mid-1990s has significantly reduced morbidities and prolonged the lifespan of people living with HIV. However ...

  2. The incidence rate of HIV type-1 drug resistance in patients on antiretroviral therapy: a nationwide population-based Danish cohort study 1999-2005

    DEFF Research Database (Denmark)

    Audelin, A.M.; Lohse, N.; Obel, N.

    2009-01-01

    BACKGROUND: Newer antiretroviral treatment regimens for HIV carry a lower risk of inducing drug resistance mutations. We estimated changes in incidence rates (IRs) of new mutations in HIV-infected individuals receiving highly active antiretroviral therapy (HAART). METHODS: Population-based data...... were obtained from the Danish HIV Cohort Study and the Danish HIV Sequence Database. We included treatment-naive patients initiating HAART after December 1997 and computed time to first drug resistance mutation, identified as new mutations detected within 1 year after a 60-day period of treatment.......077). The IR of PI resistance decreased from 7.5 (1.4-21.8) in 1999 to 2.9 (0.7-11.4) in 2002-2003 (P=0.148). The IRs were low for specific resistance mutations, except for M184V (IR 5.6 [4.0-7.9]) and K103N (IR 8.2 [5.6-12.0]). CONCLUSIONS: The incidence of acquired drug resistance has decreased among HIV...

  3. Dynamics of counterfeit alcohol and tobacco goods in the Tatarstan Republic market

    OpenAIRE

    Oleg R. Karatayev

    2015-01-01

    Objective to identify and assess the share of counterfeit products in the total volume of alcohol and tobacco products in the consumer market of Tatarstan Republic which will allow the inspection bodies to deal more effectively to prevent the spreading of counterfeit products. Methods the research proposed in this paper used methods of probability theory and mathematical statistics and the method of sampling analysis of certificates for products in accordance with applicable laws and...

  4. Antiretroviral Drug Use in a Cohort of HIV-Uninfected Women in the United States: HIV Prevention Trials Network 064.

    Directory of Open Access Journals (Sweden)

    Iris Chen

    Full Text Available Antiretroviral (ARV drug use was analyzed in HIV-uninfected women in an observational cohort study conducted in 10 urban and periurban communities in the United States with high rates of poverty and HIV infection. Plasma samples collected in 2009-2010 were tested for the presence of 16 ARV drugs. ARV drugs were detected in samples from 39 (2% of 1,806 participants: 27/181 (15% in Baltimore, MD and 12/179 (7% in Bronx, NY. The ARV drugs detected included different combinations of non-nucleoside reverse transcriptase inhibitors and protease inhibitors (1-4 drugs/sample. These data were analyzed in the context of self-reported data on ARV drug use. None of the 39 women who had ARV drugs detected reported ARV drug use at any study visit. Further research is needed to evaluate ARV drug use by HIV-uninfected individuals.

  5. 76 FR 48905 - United States Government Inter-Agency Anti-Counterfeiting Working Group: Request for Public...

    Science.gov (United States)

    2011-08-09

    ... program managers to identify items at risk for counterfeiting or requiring authentication of legitimacy... program managers to identify items at risk for counterfeiting or requiring authentication of legitimacy... identification marking methods impose a substantial burden on manufacturers/suppliers? Identify the types of...

  6. Analysis of clinical drug-drug interaction data to predict uncharacterized interaction magnitudes between antiretroviral drugs and co-medications.

    Science.gov (United States)

    Stader, Felix; Kinvig, Hannah; Battegay, Manuel; Khoo, Saye; Owen, Andrew; Siccardi, Marco; Marzolini, Catia

    2018-04-23

    Despite their high potential for drug-drug-interactions (DDI), clinical DDI studies of antiretroviral drugs (ARVs) are often lacking, because the full range of potential interactions cannot feasibly or pragmatically be studied, with some high-risk DDI studies also ethically difficult to undertake. Thus, a robust method to screen and to predict the likelihood of DDIs is required.We developed a method to predict DDIs based on two parameters: the degree of metabolism by specific enzymes such as CYP3A and the strength of an inhibitor or inducer. These parameters were derived from existing studies utilizing paradigm substrates, inducers and inhibitors of CYP3A, to assess the predictive performance of this method by verifying predicted magnitudes of changes in drug exposure against clinical DDI studies involving ARVs.The derived parameters were consistent with the FDA classification of sensitive CYP3A substrates and the strength of CYP3A inhibitors and inducers. Characterized DDI magnitudes (n = 68) between ARVs and co-medications were successfully quantified meaning 53%, 85% and 98% of the predictions were within 1.25-fold (0.80 - 1.25), 1.5-fold (0.66 - 1.48) and 2-fold (0.66 - 1.94) of the observed clinical data. In addition, the method identifies CYP3A substrates likely to be highly or conversely minimally impacted by CYP3A inhibitors or inducers, thus categorizing the magnitude of DDIs.The developed effective and robust method has the potential to support a more rational identification of dose adjustment to overcome DDIs being particularly relevant in a HIV-setting giving the treatments complexity, high DDI risk and limited guidance on the management of DDIs. Copyright © 2018 American Society for Microbiology.

  7. Combatting Falsification and Counterfeiting Of Medicinal Products in the European Union

    DEFF Research Database (Denmark)

    Kohli, Vishv Priya

    and falsification of medicinal products meets the social objectives of public health (Articles 9 and 168) and consumer protection (Articles 12 and 169), as envisaged by the Treaty on the Function of the European Union. The thesis establishes that the problem of counterfeiting and falsification of medicinal products...... lies at the intersection of three spheres of law - IP law, Medicine law, and Criminal law. This insight provides the foundation for the understanding of the weaknesses in the legal regime that contains tools for combatting counterfeiting and falsification of medicines in the EU....

  8. The discovery and development of antiretroviral agents

    NARCIS (Netherlands)

    Lange, Joep M. A.; Ananworanich, Jintanat

    2014-01-01

    Since the discovery of HIV as the causative agent of AIDS in 1983/1984, remarkable progress has been made in finding antiretroviral drugs (ARVs) that are effective against it. A major breakthrough occurred in 1996 when it was found that triple drug therapy (HAART) could durably suppress viral

  9. Estimating prevalence of accumulated HIV-1 drug resistance in a cohort of patients on antiretroviral therapy

    DEFF Research Database (Denmark)

    Bannister, Wendy P; Cozzi-Lepri, Alessandro; Kjær, Jesper

    2011-01-01

    Estimating the prevalence of accumulated HIV drug resistance in patients receiving antiretroviral therapy (ART) is difficult due to lack of resistance testing at all occasions of virological failure and in patients with undetectable viral load. A method to estimate this for 6498 EuroSIDA patients...... who were under follow-up on ART at 1 July 2008 was therefore developed by imputing data on patients with no prior resistance test results, based on the probability of detecting resistance in tested patients with similar profiles....

  10. Maternal and infant health is protected by antiretroviral drug strategies that preserve breastfeeding by HIV-positive women

    Directory of Open Access Journals (Sweden)

    Louise Kuhn

    2012-03-01

    Full Text Available The South African Department of Health is justified in withdrawing support for free infant formula. By so doing, it recognises that any intervention that might detract from breast feeding poses a serious threat to infant survival. Since evidence is now strong that antiretroviral drugs used during lactation prevent transmission of infection from a seropositive mother, strategies that promote breastfeeding can now be recommended for enhancing the health of mothers and infants.

  11. Anti-Counterfeiting Quick Response Code with Emission Color of Invisible Metal-Organic Frameworks as Encoding Information.

    Science.gov (United States)

    Wang, Yong-Mei; Tian, Xue-Tao; Zhang, Hui; Yang, Zhong-Rui; Yin, Xue-Bo

    2018-06-08

    Counterfeiting is a global epidemic that is compelling the development of new anti-counterfeiting strategy. Herein, we report a novel multiple anti-counterfeiting encoding strategy of invisible fluorescent quick response (QR) codes with emission color as information storage unit. The strategy requires red, green, and blue (RGB) light-emitting materials for different emission colors as encrypting information, single excitation for all of the emission for practicability, and ultraviolet (UV) excitation for invisibility under slight. Therefore, RGB light-emitting nanoscale metal-organic frameworks (NMOFs) are designed as inks to construct the colorful light-emitting boxes for information encrypting, while three black vertex boxes were used for positioning. Full-color emissions are obtained by mixing the trichromatic NMOFs inks through inkjet printer. The encrypting information capacity is easily adjusted by the number of light-emitting boxes with the infinite emission colors. The information is decoded with specific excitation light at 275 nm, making the QR codes invisible under daylight. The composition of inks, invisibility, inkjet printing, and the abundant encrypting information all contribute to multiple anti-counterfeiting. The proposed QR codes pattern holds great potential for advanced anti-counterfeiting.

  12. Expression of Genes for Drug Transporters in the Human Female Genital Tract and Modulatory Effect of Antiretroviral Drugs.

    Directory of Open Access Journals (Sweden)

    Karolin Hijazi

    Full Text Available Anti-retroviral (ARV -based microbicides are one of the strategies pursued to prevent HIV-1 transmission. Delivery of ARV drugs to subepithelial CD4+ T cells at concentrations for protection is likely determined by drug transporters expressed in the cervicovaginal epithelium. To define the role of drug transporters in mucosal disposition of topically applied ARV-based microbicides, these must be tested in epithelial cell line-based biopharmaceutical assays factoring the effect of relevant drug transporters. We have characterised gene expression of influx and efflux drug transporters in a panel of cervicovaginal cell lines and compared this to expression in cervicovaginal tissue. We also investigated the effect of dapivirine, darunavir and tenofovir, currently at advanced stages of microbicides development, on expression of drug transporters in cell lines. Expression of efflux ABC transporters in cervical tissue was best represented in HeLa, Ect1/E6E7 and End1/E6E7 cell lines. Expression of influx OCT and ENT transporters in ectocervix matched expression in Hela while expression of influx SLCO transporters in vagina was best reflected in VK2/E6E7 cell line. Stimulation with darunavir and dapivirine upregulated MRP transporters, including MRP5 involved in transport of tenofovir. Dapivirine also significantly downregulated tenofovir substrate MRP4 in cervical cell lines. Treatment with darunavir and dapivirine showed no significant effect on expression of BCRP, MRP2 and P-glycoprotein implicated in efflux of different ARV drugs. Darunavir strongly induced expression in most cell lines of CNT3 involved in cell uptake of nucleotide/nucleoside analogue reverse transcriptase inhibitors and SLCO drug transporters involved in cell uptake of protease inhibitors. This study provides insight into the suitability of cervicovaginal cell lines for assessment of ARV drugs in transport kinetics studies. The modulatory effect of darunavir and dapivirine on

  13. Expression of Genes for Drug Transporters in the Human Female Genital Tract and Modulatory Effect of Antiretroviral Drugs.

    Science.gov (United States)

    Hijazi, Karolin; Cuppone, Anna M; Smith, Kieron; Stincarelli, Maria A; Ekeruche-Makinde, Julia; De Falco, Giulia; Hold, Georgina L; Shattock, Robin; Kelly, Charles G; Pozzi, Gianni; Iannelli, Francesco

    2015-01-01

    Anti-retroviral (ARV) -based microbicides are one of the strategies pursued to prevent HIV-1 transmission. Delivery of ARV drugs to subepithelial CD4+ T cells at concentrations for protection is likely determined by drug transporters expressed in the cervicovaginal epithelium. To define the role of drug transporters in mucosal disposition of topically applied ARV-based microbicides, these must be tested in epithelial cell line-based biopharmaceutical assays factoring the effect of relevant drug transporters. We have characterised gene expression of influx and efflux drug transporters in a panel of cervicovaginal cell lines and compared this to expression in cervicovaginal tissue. We also investigated the effect of dapivirine, darunavir and tenofovir, currently at advanced stages of microbicides development, on expression of drug transporters in cell lines. Expression of efflux ABC transporters in cervical tissue was best represented in HeLa, Ect1/E6E7 and End1/E6E7 cell lines. Expression of influx OCT and ENT transporters in ectocervix matched expression in Hela while expression of influx SLCO transporters in vagina was best reflected in VK2/E6E7 cell line. Stimulation with darunavir and dapivirine upregulated MRP transporters, including MRP5 involved in transport of tenofovir. Dapivirine also significantly downregulated tenofovir substrate MRP4 in cervical cell lines. Treatment with darunavir and dapivirine showed no significant effect on expression of BCRP, MRP2 and P-glycoprotein implicated in efflux of different ARV drugs. Darunavir strongly induced expression in most cell lines of CNT3 involved in cell uptake of nucleotide/nucleoside analogue reverse transcriptase inhibitors and SLCO drug transporters involved in cell uptake of protease inhibitors. This study provides insight into the suitability of cervicovaginal cell lines for assessment of ARV drugs in transport kinetics studies. The modulatory effect of darunavir and dapivirine on expression of drug

  14. Aging, Counterfeiting Configuration Control (AC3)

    Science.gov (United States)

    2010-01-31

    Systems Intergrated Into AC3 CABS - Common As-Built System PRISM - Process Re-inventing Integration Systems for Manufacturing PDM - Product Data...looks forward to deploying the completed tool at Raytheon in a true production environment, for as much as we like the challenge associated with...performance of DoD systems. DoD systems are particularly susceptible to intrusion of counterfeit parts, especially during surge and extended production

  15. Attitude towards the purchase of counterfeits: Antecedents and effect on intention to purchase

    OpenAIRE

    Viot , Catherine; Le Roux , André; Kremer , Florence

    2014-01-01

    International audience; Counterfeiting is a major issue for companies, public institutions and consumers. Despite extensive literature on the subject in marketing, an instrument for measuring the wide variety of the determinants of attitude towards and intention to purchase counterfeit products is lacking. A second-order model comprising thirteen determinants, grouped into three latent constructs, is validated. This model includes a dimension related to the societal consequences of counterfei...

  16. High-levels of acquired drug resistance in adult patients failing first-line antiretroviral therapy in a rural HIV treatment programme in KwaZulu-Natal, South Africa.

    Directory of Open Access Journals (Sweden)

    Justen Manasa

    Full Text Available To determine the frequency and patterns of acquired antiretroviral drug resistance in a rural primary health care programme in South Africa.Cross-sectional study nested within HIV treatment programme.Adult (≥ 18 years HIV-infected individuals initially treated with a first-line stavudine- or zidovudine-based antiretroviral therapy (ART regimen and with evidence of virological failure (one viral load >1000 copies/ml were enrolled from 17 rural primary health care clinics. Genotypic resistance testing was performed using the in-house SATuRN/Life Technologies system. Sequences were analysed and genotypic susceptibility scores (GSS for standard second-line regimens were calculated using the Stanford HIVDB 6.0.5 algorithms.A total of 222 adults were successfully genotyped for HIV drug resistance between December 2010 and March 2012. The most common regimens at time of genotype were stavudine, lamivudine and efavirenz (51%; and stavudine, lamivudine and nevirapine (24%. Median duration of ART was 42 months (interquartile range (IQR 32-53 and median duration of antiretroviral failure was 27 months (IQR 17-40. One hundred and ninety one (86% had at least one drug resistance mutation. For 34 individuals (15%, the GSS for the standard second-line regimen was <2, suggesting a significantly compromised regimen. In univariate analysis, individuals with a prior nucleoside reverse-transcriptase inhibitor (NRTI substitution were more likely to have a GSS <2 than those on the same NRTIs throughout (odds ratio (OR 5.70, 95% confidence interval (CI 2.60-12.49.There are high levels of drug resistance in adults with failure of first-line antiretroviral therapy in this rural primary health care programme. Standard second-line regimens could potentially have had reduced efficacy in about one in seven adults involved.

  17. Positive Effects Of Counterfeiting On Luxury Goods: An Empirical Exploration With Consumers

    OpenAIRE

    Giacomo Gistri; Stefano Pace; Simona Romani

    2011-01-01

    In this study we explore the positive effects that counterfeiting might have on the original luxury brands. Through an experiment, we study whether the awareness of a counterfeited version of a fashion luxury brand can increase the purchase intention of the original brands and the price that subjects would like to pay to get the original brand. We account for the notoriety of the brand (whether well known or fictional). We control for the need for status and the expertise of the respondents. ...

  18. Impact of use of alcohol and illicit drugs by AIDS patients on adherence to antiretroviral therapy in Bahia, Brazil.

    Science.gov (United States)

    Teixeira, Celia; Dourado, Maria De Lourdes; Santos, Marcio P; Brites, Carlos

    2013-05-01

    Use of alcohol and illicit drugs is a common finding among HIV-infected individuals, but there are many open questions about its impact on adherence to antiretroviral therapy and virological outcomes. Our study aimed to evaluate the impact of the use of alcohol and illicit drugs on the adherence to antiretroviral therapy (ART) among patients starting ART in Salvador, Brazil. We followed up 144 AIDS patients initiating ART for a 6-month period. At baseline, they were interviewed about demographics, behavior, and use of illicit drugs and alcohol. All of them had HIV-1 RNA plasma viral load and CD4(+)/CD8(+) cells count measured before starting therapy. After 60 days of treatment they were asked to answer a new questionnaire on adherence to ART. All patients were monitored during the following months, and new CD4(+) cell count/HIV-1 RNA plasma viral load determinations were performed after 6 months of therapy. Optimal adherence to therapy was defined by self-reported questionnaire, by 95% use of prescribed drug doses, and by using plasma HIV-1 RNA viral load as a biological marker. A total of 61 (42.4%) patients reported alcohol use, 7 (4.9%) used illicit drugs, and 17 (11.8%) used both alcohol and illicit drugs. Being in a steady relationship was protective to nonadherence (95% CI: 0.18-0.84). Missing more than two medical visits was also associated with a 68% higher likelihood of nonadherence (95% CI: 0.10-1.02). After logistic regression we detected a higher risk of nonadherence for patients declaring use of alcohol plus illicit drugs (odds ratio=6.0; 95% CI: 1.78-20.28) or high-intensity use of alcohol (odds ratio=3.29; 95% CI: 1.83-5.92). AIDS patients using alcohol and/or illicit drugs are socially vulnerable, and need specific and flexible programs, combining mental health care, harm reduction strategies, and assisted drug therapy to maximize the chances of successful use of ART.

  19. Independent oversight review of the Department of Energy Quality Assurance Program for suspect/counterfeit parts. Revision 1

    International Nuclear Information System (INIS)

    1996-05-01

    To address the potential threat that suspect/counterfeit parts could pose to DOE workers and the public, the Office of the Deputy Assistant Secretary for Oversight initiated a number of activities beginning in mid-1995. Oversight placed increased emphasis on the field's quality assurance-suspect/counterfeit parts programs during safety management evaluations, in keeping with the Office of Environment, Safety and Health (EH) oversight responsibilities, which include oversight of the Department's quality assurance (QA) programs. In addition, Oversight reviewed relevant policy documents and occurrence reports to determine the nature and magnitude of the problem within the Department. The results of that review, contained in an Office of Oversight report, Independent Oversight Analysis of Suspect/Counterfeit Parts Within the Department of Energy (November 1995), indicate a lack of consistency and comprehensiveness in the Department's QA-suspect/counterfeit parts program. A detailed analysis of the causes and impacts of the problem was recommended. In response, this review was initiated to determine the effectiveness of the Department's QA program for suspect/counterfeit parts. This study goes beyond merely assessing and reporting the status of the program, however. It is the authors intention to highlight the complex issues associated with suspect/counterfeit parts in the Department today and to present approaches that DOE managers might consider to address these issues

  20. Independent oversight review of the Department of Energy Quality Assurance Program for suspect/counterfeit parts. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-05-01

    To address the potential threat that suspect/counterfeit parts could pose to DOE workers and the public, the Office of the Deputy Assistant Secretary for Oversight initiated a number of activities beginning in mid-1995. Oversight placed increased emphasis on the field`s quality assurance-suspect/counterfeit parts programs during safety management evaluations, in keeping with the Office of Environment, Safety and Health (EH) oversight responsibilities, which include oversight of the Department`s quality assurance (QA) programs. In addition, Oversight reviewed relevant policy documents and occurrence reports to determine the nature and magnitude of the problem within the Department. The results of that review, contained in an Office of Oversight report, Independent Oversight Analysis of Suspect/Counterfeit Parts Within the Department of Energy (November 1995), indicate a lack of consistency and comprehensiveness in the Department`s QA-suspect/counterfeit parts program. A detailed analysis of the causes and impacts of the problem was recommended. In response, this review was initiated to determine the effectiveness of the Department`s QA program for suspect/counterfeit parts. This study goes beyond merely assessing and reporting the status of the program, however. It is the authors intention to highlight the complex issues associated with suspect/counterfeit parts in the Department today and to present approaches that DOE managers might consider to address these issues.

  1. Transporters for Antiretroviral Drugs in Colorectal CD4+ T Cells and Circulating α4β7 Integrin CD4+ T Cells: Implications for HIV Microbicides.

    Science.gov (United States)

    Mukhopadhya, Indrani; Murray, Graeme I; Duncan, Linda; Yuecel, Raif; Shattock, Robin; Kelly, Charles; Iannelli, Francesco; Pozzi, Gianni; El-Omar, Emad M; Hold, Georgina L; Hijazi, Karolin

    2016-09-06

    CD4+ T lymphocytes in the colorectal mucosa are key in HIV-1 transmission and dissemination. As such they are also the primary target for antiretroviral (ARV)-based rectal microbicides for pre-exposure prophylaxis. Drug transporters expressed in mucosal CD4+ T cells determine ARV distribution across the cell membrane and, most likely, efficacy of microbicides. We describe transporters for antiretroviral drugs in colorectal mucosal CD4+ T lymphocytes and compare gene expression with circulating α4β7+CD4+ T cells, which traffic to the intestine and have been shown to be preferentially infected by HIV-1. Purified total CD4+ T cells were obtained from colorectal tissue and blood samples by magnetic separation. CD4+ T cells expressing α4β7 integrin were isolated by fluorescence-activated cell sorting from peripheral blood mononuclear cells of healthy volunteers. Expressions of 15 efflux and uptake drug transporter genes were quantified using Taqman qPCR assays. Expression of efflux transporters MRP3, MRP5, and BCRP and uptake transporter CNT2 were significantly higher in colorectal CD4+ T cells compared to circulating CD4+ T cells (p = 0.01-0.03). Conversely, circulating α4β7+CD4+ T cells demonstrated significantly higher expression of OATPD compared to colorectal CD4+ T cells (p = 0.001). To the best of our knowledge this is the first report of drug transporter gene expression in colorectal CD4+ and peripheral α4β7+CD4+ T cells. The qualitative and quantitative differences in drug transporter gene expression profiles between α4β7+CD4+ T cells and total mucosal CD4+ T cells may have significant implications for the efficacy of rectally delivered ARV-microbicides. Most notably, we have identified efflux drug transporters that could be targeted by selective inhibitors or beneficial drug-drug interactions to enhance intracellular accumulation of antiretroviral drugs.

  2. Cost-Effectiveness of Antiretroviral Therapy for Multidrug-Resistant HIV: Past, Present, and Future

    Directory of Open Access Journals (Sweden)

    Marianne Harris

    2012-01-01

    Full Text Available In the early years of the highly active antiretroviral therapy (HAART era, HIV with resistance to two or more agents in different antiretroviral classes posed a significant clinical challenge. Multidrug-resistant (MDR HIV was an important cause of treatment failure, morbidity, and mortality. Treatment options at the time were limited; multiple drug regimens with or without enfuvirtide were used with some success but proved to be difficult to sustain for reasons of tolerability, toxicity, and cost. Starting in 2006, data began to emerge supporting the use of new drugs from the original antiretroviral classes (tipranavir, darunavir, and etravirine and drugs from new classes (raltegravir and maraviroc for the treatment of MDR HIV. Their availability has enabled patients with MDR HIV to achieve full and durable viral suppression with more compact and cost-effective regimens including at least two and often three fully active agents. The emergence of drug-resistant HIV is expected to continue to become less frequent in the future, driven by improvements in the convenience, tolerability, efficacy, and durability of first-line HAART regimens. To continue this trend, the optimal rollout of HAART in both rich and resource-limited settings will require careful planning and strategic use of antiretroviral drugs and monitoring technologies.

  3. 75 FR 36062 - Notice of Enforcement Policy Symposium on Combating Counterfeiting in the 21st Century

    Science.gov (United States)

    2010-06-24

    ... second panel on criminal procedure will involve a discussion of enforcement policy involving the... Enforcement Policy Symposium on Combating Counterfeiting in the 21st Century AGENCY: United States Patent and... United States Government enforcement policy regarding counterfeit goods involving health and safety...

  4. Comparative manufacture and cell-based delivery of antiretroviral nanoformulations

    Directory of Open Access Journals (Sweden)

    Balkundi S

    2011-12-01

    Full Text Available Shantanu Balkundi1, Ari S Nowacek1, Ram S Veerubhotla1, Han Chen2, Andrea Martinez-Skinner1, Upal Roy1, R Lee Mosley1,3, Georgette Kanmogne1, Xinming Liu1,3,4, Alexander V Kabanov3,4, Tatiana Bronich3,4, JoEllyn McMillan1, Howard E Gendelman1,31Department of Pharmacology and Experimental Neuroscience, University of Nebraska Medical Center, Omaha, NE, USA; 2Center for Biotechnology, University of Nebraska-Lincoln, Lincoln, NE, USA; 3Center for Drug Delivery and Nanomedicine, University of Nebraska Medical Center, Omaha, NE, USA; 4Department of Pharmaceutical Sciences, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USAAbstract: Nanoformulations of crystalline indinavir, ritonavir, atazanavir, and efavirenz were manufactured by wet milling, homogenization or sonication with a variety of excipients. The chemical, biological, immune, virological, and toxicological properties of these formulations were compared using an established monocyte-derived macrophage scoring indicator system. Measurements of drug uptake, retention, release, and antiretroviral activity demonstrated differences amongst preparation methods. Interestingly, for drug cell targeting and antiretroviral responses the most significant difference among the particles was the drug itself. We posit that the choice of drug and formulation composition may ultimately affect clinical utility.Keywords: human immunodeficiency virus type one, nanotoxicology, monocyte-derived macrophage, nanoformulated antiretroviral therapy, manufacturing techniques

  5. Pattern and Determinants of Antiretroviral Drug Adherence among Nigerian Pregnant Women

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    S. O. Ekama

    2012-01-01

    Full Text Available Background. The need for a high level of adherence to antiretroviral drugs has remained a major hurdle to achieving maximal benefit from its use in pregnancy. This study was designed to determine the level of adherence and identify factors that influence adherence during pregnancy. Method. This is a cross-sectional study utilizing a semistructured questionnaire. Bivariate and multiple logistic regression models were used to determine factors independently associated with good drug adherence during pregnancy. Result. 137 (80.6% of the interviewed 170 women achieved adherence level of ≥95% using 3 day recall. The desire to protect the unborn child was the greatest motivation (51.8% for good adherence. Fear of being identified as HIV positive (63.6% was the most common reason for nonadherence. Marital status, disclosure of HIV status, good knowledge of ART, and having a treatment supporter were found to be significantly associated with good adherence at bivariate analysis. However, after controlling for confounders, only HIV status disclosure and having a treatment partner retained their association with good adherence. Conclusion. Disclosure of HIV status and having treatment support are associated with good adherence. Maternal desire to protect the child was the greatest motivator for adherence.

  6. Destruction of illegal things and devices to contrast the counterfeiting

    Directory of Open Access Journals (Sweden)

    Dr.Sc. Mario Antinucci

    2016-01-01

    Full Text Available The movement of goods illegal and counterfeit in the circuit of the economy and the labor market, has put in place of criminal policy internal supranational and a primary need of confiscation and destruction in relation to safety issues transnational linked to all forms of counterfeiting, piracy agro-food to fraud in industrial brands of high fashion et similia: from here the major node of the procedure of destruction of goods illegal and counterfeit subject to seizure and confiscation and respect of guarantees communities of the criminal process, especially in the light of the amendment of art. 260, co. 3 bis and ter, c.p.p. with the d.l. 23-5-2008, n. 92 and subsequent amendments (so-called Safety Package. In line with the criminal policy of ''security'', in l. 23-7-2009, n. 99, the so-called Decree Development, between the ''darrangements for the development and the internationalization of enterprises, as well as in the field of energy'' and  wanted to redesign, with analytical provisions of particular edge, the perimeter of the criminal-law protection ''Dei property rights industrial'' through the introduction of four new hypothesis of offenses of counterfeiting (artt. 473, 474, 474 b and c, 517 b and c, c.p. and related hypothesis of obligatory confiscation (art. 474 bis and 517 ter c.p., with implications concerning the regime differentiated penitentiary (art. 4 bis, co. 1 ter, ord. penit. in relation to the cases of belonging to criminal association aimed to commit new offenses referred to in articles 473-474 c.p. (arts. 416 bis, 6º Co., c.p. and 51, co. 3 bis, c.p.p., as well as the regulatory body containing the so-called ''responsability of administrative entities'', within the meaning of art. 19, d.lg. 8-6-2001, n. 231.

  7. Effect of transmitted drug resistance on virological and immunological response to initial combination antiretroviral therapy for HIV (EuroCoord-CHAIN joint project): a European multicohort study

    DEFF Research Database (Denmark)

    Wittkop, Linda; Günthard, Huldrych F; de Wolf, Frank

    2011-01-01

    The effect of transmitted drug resistance (TDR) on first-line combination antiretroviral therapy (cART) for HIV-1 needs further study to inform choice of optimum drug regimens. We investigated the effect of TDR on outcome in the first year of cART within a large European collaboration....

  8. Identification of Microorganisms Isolated From Counterfeit and Unapproved Decorative Contact Lenses.

    Science.gov (United States)

    Land, Adrian D; Penno, Katie L; Brzezinski, Jennifer L

    2018-03-01

    All contact lenses (corrective/noncorrective) are considered Class II or Class III medical devices under the Federal Food, Drug, and Cosmetic Act, which also states that contact lenses can only be obtained with a prescription. The Forensic Chemistry Center of the US Food & Drug Administration has examined over 300 decorative, noncorrective contact lenses obtained without a prescription. Our observations indicate that 60% of the counterfeit lenses and 27% of the unapproved lenses examined were positive for microbial contamination. Twenty-nine different brands of noncorrective contact lenses were examined, and 48% of them had at least one sample positive for microbial contamination. Each microorganism was further identified using DNA sequencing. Contaminated contact lenses are associated with numerous health risks, including ocular infections and conjunctivitis leading to permanent visual impairment or blindness. These results support the contention that acquiring contact lenses without a prescription is a considerable threat to consumer health and safety. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  9. Use of CdS quantum dot-functionalized cellulose nanocrystal films for anti-counterfeiting applications

    Science.gov (United States)

    Chen, L.; Lai, C.; Marchewka, R.; Berry, R. M.; Tam, K. C.

    2016-07-01

    Structural colors and photoluminescence have been widely used for anti-counterfeiting and security applications. We report for the first time the use of CdS quantum dot (QD)-functionalized cellulose nanocrystals (CNCs) as building blocks to fabricate nanothin films via layer-by-layer (LBL) self-assembly for anti-counterfeiting applications. Both negatively- and positively-charged CNC/QD nanohybrids with a high colloidal stability and a narrow particle size distribution were prepared. The controllable LBL coating process was characterized by scanning electron microscopy and ellipsometry. The rigid structure of CNCs leads to nanoporous structured films on poly(ethylene terephthalate) (PET) substrates with high transmittance (above 70%) over the entire range of visible light and also resulted in increased hydrophilicity (contact angles of ~40 degrees). Nanothin films on PET substrates showed good flexibility and enhanced stability in both water and ethanol. The modified PET films with structural colors from thin-film interference and photoluminescence from QDs can be used in anti-counterfeiting applications.Structural colors and photoluminescence have been widely used for anti-counterfeiting and security applications. We report for the first time the use of CdS quantum dot (QD)-functionalized cellulose nanocrystals (CNCs) as building blocks to fabricate nanothin films via layer-by-layer (LBL) self-assembly for anti-counterfeiting applications. Both negatively- and positively-charged CNC/QD nanohybrids with a high colloidal stability and a narrow particle size distribution were prepared. The controllable LBL coating process was characterized by scanning electron microscopy and ellipsometry. The rigid structure of CNCs leads to nanoporous structured films on poly(ethylene terephthalate) (PET) substrates with high transmittance (above 70%) over the entire range of visible light and also resulted in increased hydrophilicity (contact angles of ~40 degrees). Nanothin films

  10. Vietnamese Attitudes and Behavioural Patterns towards Counterfeit Brands

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    Giang Huynh

    2014-12-01

    Full Text Available This study examines Vietnamese female consumers’ attitudes towards counterfeit branded products; by investigating the influence of brand image, product involvement and price advantage towards decision-making processes associated with purchasing and ownership. An inductive anti-positivist approach was adopted, employing qualitative methods; drawing from in-depth interviews distilled and synthesized using Word Cloud software, as Geographic Information System (GIS based Spatial Analyses. Findings suggest that Price Advantage plays a determining and predominant role in encouraging consumers’ purchase intention of a counterfeit product. In addition, Brand Image has positive effect on the purchase intention as well; while product involvement plays no significant role in the process. Further observations point to there being paucity of literature that focuses on Vietnamese and ASEAN markets. With this is mind, a new conceptual framework was developed to reflect the nuances of the Vietnamese consumer experience; which it is suggested will be of value to scholars, practitioners and further studies.

  11. Laser photothermal diagnostics of genuine and counterfeit British and United States banknotes

    Science.gov (United States)

    Othonos, Andreas; Mandelis, Andreas; Nestoros, Marios; Christofides, Constantinos

    1997-02-01

    Laser-induced, frequency-scanned IR photothermal radiometry was used to investigate the thermophysical properties of the paper on which several genuine and counterfeit British (10 pounds) and U.S. ($DOL50, $DOL100) currency bills were printed. The radiometric photothermal amplitudes and phases were further compared with a theoretical model, which yielded simultaneous quantitative measurements of the thermal diffusivities and conductivities of the bills. Both statistical and single-specimen results demonstrated the excellent thermophysical resolution of the technique with prospects for its use in the nonintrusive, on-line identification of counterfeit banknotes.

  12. In vivo assessment of antiretroviral therapy-associated side effects

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    Eduardo Milton Ramos-Sanchez

    2014-07-01

    Full Text Available Antiretroviral therapy has been associated with side effects, either from the drug itself or in conjunction with the effects of human immunodeficiency virus infection. Here, we evaluated the side effects of the protease inhibitor (PI indinavir in hamsters consuming a normal or high-fat diet. Indinavir treatment increased the hamster death rate and resulted in an increase in triglyceride, cholesterol and glucose serum levels and a reduction in anti-oxLDL auto-antibodies. The treatment led to histopathological alterations of the kidney and the heart. These results suggest that hamsters are an interesting model for the study of the side effects of antiretroviral drugs, such as PIs.

  13. Perceptions and practices of pharmaceutical wholesalers surrounding counterfeit medicines in a developing country: a baseline survey

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    Khan Mohiuddin H

    2011-11-01

    Full Text Available Abstract Background Recent investigations by the Ministry of Health of Cambodia suggest that counterfeit medicines have been introduced into the pharmaceutical market in tampered packaging. To further explore this possibility, an interview survey was conducted at the wholesaler level to investigate the medicinal supply chain in Cambodia. Methods Managing executives of 62 (83.8% registered wholesalers of modern medicines in Cambodia were interviewed in 2009 on their knowledge of, perception on, and practices related to counterfeiting issues through a semi-structured questionnaire. Results According to our findings, 12.9% of the wholesalers had encountered counterfeit medicine. However, they demonstrated a variety of perceptions regarding this issue. A majority (59.7% defined counterfeit medicines as medicines without registration, while other definitions included medicines that were fraudulently manufactured, medicines without a batch/lot number, those containing harmful ingredients or a reduced amount of active ingredients, and expired medicines. Additionally, 8.1% responded that they did not know what counterfeit medicines were. During procurement, 66.1% of the wholesalers consider whether the product is registered in Cambodia, while 64.5% consider the credibility and quality of the products and 61.3% consider the reputation of the manufacturers. When receiving a consignment, 80.6% of wholesalers check the intactness of medicines, 72.6% check the specification and amount of medicines, 71% check Cambodian registration, 56.5% check that the packaging is intact, 54.8% check batch and lot numbers, 48.4% check the dates of manufacture and expiration, and 9.7% check analytical certificates. Out of 62 wholesalers, 14.5% had received medicines that arrived without packages or were separated from their packaging and had to be repacked before distribution. Significant statistical association was found between wholesalers who received medicines separately

  14. Perceptions and practices of pharmaceutical wholesalers surrounding counterfeit medicines in a developing country: a baseline survey.

    Science.gov (United States)

    Khan, Mohiuddin H; Akazawa, Manabu; Dararath, Eav; Kiet, Heng B; Sovannarith, Tey; Nivanna, Nam; Yoshida, Naoko; Kimura, Kazuko

    2011-11-11

    Recent investigations by the Ministry of Health of Cambodia suggest that counterfeit medicines have been introduced into the pharmaceutical market in tampered packaging. To further explore this possibility, an interview survey was conducted at the wholesaler level to investigate the medicinal supply chain in Cambodia. Managing executives of 62 (83.8%) registered wholesalers of modern medicines in Cambodia were interviewed in 2009 on their knowledge of, perception on, and practices related to counterfeiting issues through a semi-structured questionnaire. According to our findings, 12.9% of the wholesalers had encountered counterfeit medicine. However, they demonstrated a variety of perceptions regarding this issue. A majority (59.7%) defined counterfeit medicines as medicines without registration, while other definitions included medicines that were fraudulently manufactured, medicines without a batch/lot number, those containing harmful ingredients or a reduced amount of active ingredients, and expired medicines. Additionally, 8.1% responded that they did not know what counterfeit medicines were.During procurement, 66.1% of the wholesalers consider whether the product is registered in Cambodia, while 64.5% consider the credibility and quality of the products and 61.3% consider the reputation of the manufacturers. When receiving a consignment, 80.6% of wholesalers check the intactness of medicines, 72.6% check the specification and amount of medicines, 71% check Cambodian registration, 56.5% check that the packaging is intact, 54.8% check batch and lot numbers, 48.4% check the dates of manufacture and expiration, and 9.7% check analytical certificates.Out of 62 wholesalers, 14.5% had received medicines that arrived without packages or were separated from their packaging and had to be repacked before distribution. Significant statistical association was found between wholesalers who received medicines separately from their packs/containers and who consider their

  15. Prices of second-line antiretroviral treatment for middle-income countries inside versus outside sub-Saharan Africa.

    Science.gov (United States)

    Simmons, Bryony; Hill, Andrew; Ford, Nathan; Ruxrungtham, Kiat; Ananworanich, Jintanat

    2014-01-01

    Antiretrovirals are available at low prices in sub-Saharan Africa, but these prices may not be consistently available for middle-income countries in other regions with large HIV epidemics. Over 30% of HIV infected people live in countries outside sub-Saharan Africa. Several key antiretrovirals are still on patent, with generic production restricted. We assessed price variations for key antiretroviral drugs inside versus outside sub-Saharan Africa. HIV drug prices used in national programmes (2010-2014) were extracted from the WHO Global Price Reporting Mechanism database for all reporting middle-income countries as classified by the World Bank. Treatment costs (branded and generic) were compared for countries inside sub-Saharan Africa versus those outside. Five key second-line antiretrovirals were analysed: abacavir, atazanavir, darunavir, lopinavir/ritonavir, raltegravir. Prices of branded antiretrovirals were significantly higher outside sub-Saharan Africa (psub-Saharan Africa versus $4689 (IQR $4075-5717) in non-African middle-income countries, an increase of 541%. However, when supplied by generic companies, most antiretrovirals were similarly priced between countries in sub-Saharan Africa and other regions. Pharmaceutical companies are selling antiretrovirals to non-African middle-income countries at prices 74-541% higher than African countries with similar gross national incomes. However, generic companies are selling most of these drugs at similar prices across regions. Mechanisms to ensure fair pricing for patented antiretrovirals across both African and non-African middle-income countries need to be improved, to ensure sustainable treatment access.

  16. Transmitted drug resistant HIV-1 and association with virologic and CD4 cell count response to combination antiretroviral therapy in the EuroSIDA Study

    DEFF Research Database (Denmark)

    Bannister, Wendy P; Cozzi-Lepri, Alessandro; Clotet, Bonaventura

    2008-01-01

    OBJECTIVES: To investigate prevalence of transmitted drug-resistant human immunodeficiency virus (TDR) and factors associated with TDR and to compare virological and CD4 count response to combination antiretroviral therapy. METHODS: In this study, 525 mostly chronically infected EuroSIDA patients...

  17. Forensic classification of counterfeit banknote paper by X-ray fluorescence and multivariate statistical methods.

    Science.gov (United States)

    Guo, Hongling; Yin, Baohua; Zhang, Jie; Quan, Yangke; Shi, Gaojun

    2016-09-01

    Counterfeiting of banknotes is a crime and seriously harmful to economy. Examination of the paper, ink and toners used to make counterfeit banknotes can provide useful information to classify and link different cases in which the suspects use the same raw materials. In this paper, 21 paper samples of counterfeit banknotes seized from 13 cases were analyzed by wavelength dispersive X-ray fluorescence. After measuring the elemental composition in paper semi-quantitatively, the normalized weight percentage data of 10 elements were processed by multivariate statistical methods of cluster analysis and principle component analysis. All these paper samples were mainly classified into 3 groups. Nine separate cases were successfully linked. It is demonstrated that elemental composition measured by XRF is a useful way to compare and classify papers used in different cases. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  18. Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study

    Science.gov (United States)

    Naughton, Bernard; Roberts, Lindsey; Dopson, Sue; Chapman, Stephen; Brindley, David

    2016-01-01

    Objectives To identify the authentication and detection rate of serialised medicines using medicines authentication technology. Design and intervention 4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure external database cross-checking, triggered by the scanning of a two-dimensional data matrix with a unit specific 12-digit serial code. 4% of medicines included were preprogrammed with a message to identify the product as either expired, pack recalled, product recalled or counterfeit. Setting A site within a large UK National Health Service teaching hospital trust. Participants Accredited checking staff, pharmacists and dispensers in a pharmacy department. Primary outcome measures Authentication and detection rate of counterfeit expired and recalled medicines. Results The operational detection rate of counterfeit, recalled and expired medicines scanned as a combined group was 81.4% (stage 1 (S1)) and 87% (stage 2 (S2)). The technology's technical detection rate (TDR) was 100%; however, not all medicines were scanned and of those that were scanned not all that generated a warning message were quarantined. Owing to an operational authentication rate (OAR) of 66.3% (over both stages), only 31.8% of counterfeit medicines, 58% of recalled drugs and 64% of expired medicines were detected as a proportion of those entered into the study. Response times (RTs) of 152 ms (S1) and 165 ms (S2) were recorded, meeting the falsified medicines directive-mandated 300 ms limit. Conclusions TDRs and RTs were not a limiting factor in this study. The suboptimal OAR poses significant quality and safety issues with this detection approach. Authentication at the checking stage, however, demonstrated higher OARs. There is a need for further qualitative research to establish the reasons for less than absolute authentication and detection rates in the hospital environment to improve this

  19. Impact of injecting drug use on response to highly active antiretroviral treatment in HIV-1-infected patients: a nationwide population-based cohort study

    DEFF Research Database (Denmark)

    Larsen, Mette Vang; Omland, Lars; Gerstoft, Jan

    2010-01-01

    The objective of this study was to determine the effect of highly active antiretroviral therapy (HAART) in human immunodeficiency virus (HIV)-infected patients infected through injecting drug use (injecting drug users, IDUs) compared to patients infected via other routes (non-IDUs). We conducted...... for non-IDUs, and IDUs initiated HAART later than non-IDUs. In conclusion, more than half of the HIV-infected patients in Denmark infected through injecting drug use gained full viral suppression after initiating HAART. Absolute CD4(+) cell count was lower and mortality higher among IDUs than non-IDUs....

  20. NFC based Equipment Qualification Management (NEQM) system preventing counterfeit and fraudulent item

    Energy Technology Data Exchange (ETDEWEB)

    Chang, C.K., E-mail: ckchang@kings.ac.kr [KEPCO International Nuclear Graduate School, Ulsan (Korea, Republic of); Lee, K.J., E-mail: klee@khu.ac.kr [Kyung Hee Univ., Seoul (Korea, Republic of)

    2014-07-01

    Qualification of equipment essential to safety in nuclear power plants (NPPs) ensures its capability to perform designated safety functions on demand under postulated service conditions. However, a number of incidents identified by the NRC since 1980s catalysed the US nuclear industry to adopt standard precautions to guard against counterfeit items. The purpose of this paper is to suggest the NFC (Near Field Communication) based equipment qualification management system preventing counterfeit and fraudulent items. The NEQM (NFC based Equipment Qualification Management) system work with the support of legacy systems such as PMS (Procurement Management System) and FMS (Facility management System). (author)

  1. NFC based Equipment Qualification Management (NEQM) system preventing counterfeit and fraudulent item

    International Nuclear Information System (INIS)

    Chang, C.K.; Lee, K.J.

    2014-01-01

    Qualification of equipment essential to safety in nuclear power plants (NPPs) ensures its capability to perform designated safety functions on demand under postulated service conditions. However, a number of incidents identified by the NRC since 1980s catalysed the US nuclear industry to adopt standard precautions to guard against counterfeit items. The purpose of this paper is to suggest the NFC (Near Field Communication) based equipment qualification management system preventing counterfeit and fraudulent items. The NEQM (NFC based Equipment Qualification Management) system work with the support of legacy systems such as PMS (Procurement Management System) and FMS (Facility management System). (author)

  2. Guidelines for using antiretroviral agents among HIV-infected adults and adolescents.

    Science.gov (United States)

    Dybul, Mark; Fauci, Anthony S; Bartlett, John G; Kaplan, Jonathan E; Pau, Alice K

    2002-09-03

    The availability of an increasing number of antiretroviral agents and the rapid evolution of new information have introduced substantial complexity into treatment regimens for persons infected with human immunodeficiency virus (HIV). In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for clinical management of HIV-infected adults and adolescents (CDC. Report of the NIH Panel To Define Principles of Therapy of HIV Infection and Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. MMWR. 1998;47[RR-5]:1-41). This report, which updates the 1998 guidelines, addresses 1) using testing for plasma HIV ribonucleic acid levels (i.e., viral load) and CD4+ T cell count; 2) using testing for antiretroviral drug resistance; 3) considerations for when to initiate therapy; 4) adherence to antiretroviral therapy; 5) considerations for therapy among patients with advanced disease; 6) therapy-related adverse events; 7) interruption of therapy; 8) considerations for changing therapy and available therapeutic options; 9) treatment for acute HIV infection; 10) considerations for antiretroviral therapy among adolescents; 11) considerations for antiretroviral therapy among pregnant women; and 12) concerns related to transmission of HIV to others. Antiretroviral regimens are complex, have serious side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance because of nonadherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic decisions are critical. Treatment should usually be offered to all patients with symptoms ascribed to HIV infection. Recommendations for offering antiretroviral therapy among asymptomatic patients require analysis of real and potential risks and benefits. In general

  3. Adverse effects of antiretroviral therapy for HIV infection: a review of selected topics

    NARCIS (Netherlands)

    Nolan, David; Reiss, Peter; Mallal, Simon

    2005-01-01

    In the current era of HIV treatment, the toxicity profiles of antiretroviral drugs have increasingly emerged as a basis for selecting initial antiretroviral regimens as well as a reason for switching therapy in treatment-experienced patients. In this respect, an intensive research effort involving

  4. Low Non-structured Antiretroviral Therapy Interruptions in HIV-Infected Persons Who Inject Drugs Receiving Multidisciplinary Comprehensive HIV Care at an Outpatient Drug Abuse Treatment Center.

    Science.gov (United States)

    Vallecillo, Gabriel; Mojal, Sergio; Roquer, Albert; Samos, Pilar; Luque, Sonia; Martinez, Diana; Martires, Paula Karen; Torrens, Marta

    2016-05-01

    Continuous HIV treatment is necessary to ensure successful combined antiretroviral therapy (cART). The aim of this study was to evaluate the incidence of patient-initiated non-structured treatment interruptions in HIV-infected persons who inject drugs and who received a multidisciplinary comprehensive program, including medical HIV care, drug-dependence treatment and psychosocial support, at a drug outpatient addiction center. Non-structured treatment interruptions were defined as ≥30 consecutive days off cART without medical indication. During a median follow-up of 53.8 months, 37/132 (28 %) patients experienced the first non-structured treatment interruptions. The cumulative probability of cART interruption at 5 years was 31.2 % (95 % CI 22.4-40.0). Current drug use injection ≥1/day (HR 14.77; 95 % CI 5.90-36.96) and cART naive patients (HR 0.35, 95 % CI 0.14-0.93) were predictive factors for non-structured treatment interruptions. HIV care provided at a drug addiction center is a useful strategy to sustain continuous cART, however, drug abstinence is essential for the long-term maintenance of cART.

  5. Antiretroviral Drug Use in a Cross-Sectional Population Survey in Africa: NIMH Project Accept (HPTN 043).

    Science.gov (United States)

    Fogel, Jessica M; Clarke, William; Kulich, Michal; Piwowar-Manning, Estelle; Breaud, Autumn; Olson, Matthew T; Marzinke, Mark A; Laeyendecker, Oliver; Fiamma, Agnès; Donnell, Deborah; Mbwambo, Jessie K K; Richter, Linda; Gray, Glenda; Sweat, Michael; Coates, Thomas J; Eshleman, Susan H

    2017-02-01

    Antiretroviral (ARV) drug treatment benefits the treated individual and can prevent HIV transmission. We assessed ARV drug use in a community-randomized trial that evaluated the impact of behavioral interventions on HIV incidence. Samples were collected in a cross-sectional survey after a 3-year intervention period. ARV drug testing was performed using samples from HIV-infected adults at 4 study sites (Zimbabwe; Tanzania; KwaZulu-Natal and Soweto, South Africa; survey period 2009-2011) using an assay that detects 20 ARV drugs (6 nucleoside/nucleotide reverse transcriptase inhibitors, 3 nonnucleoside reverse transcriptase inhibitors, and 9 protease inhibitors; maraviroc; raltegravir). ARV drugs were detected in 2011 (27.4%) of 7347 samples; 88.1% had 1 nonnucleoside reverse transcriptase inhibitors ± 1-2 nucleoside/nucleotide reverse transcriptase inhibitors. ARV drug detection was associated with sex (women>men), pregnancy, older age (>24 years), and study site (P < 0.0001 for all 4 variables). ARV drugs were also more frequently detected in adults who were widowed (P = 0.006) or unemployed (P = 0.02). ARV drug use was more frequent in intervention versus control communities early in the survey (P = 0.01), with a significant increase in control (P = 0.004) but not in intervention communities during the survey period. In KwaZulu-Natal, a 1% increase in ARV drug use was associated with a 0.14% absolute decrease in HIV incidence (P = 0.018). This study used an objective, biomedical approach to assess ARV drug use on a population level. This analysis identified factors associated with ARV drug use and provided information on ARV drug use over time. ARV drug use was associated with lower HIV incidence at 1 study site.

  6. Drug resistance mutations in HIV type 1 isolates from naive patients eligible for first line antiretroviral therapy in JJ Hospital, Mumbai, India.

    Science.gov (United States)

    Deshpande, Alake; Karki, Surendra; Recordon-Pinson, Patricia; Fleury, Herve J

    2011-12-01

    More than 50 HIV-1-infected patients, naive of antiretroviral therapy (ART) but eligible for first line ART in JJ Hospital, Mumbai, India were investigated for surveillance drug resistance mutations (SDRMs); all but one virus belonged to subtype C; we could observe SDRMs to nonnucleoside reverse transcriptase inhibitors and protease inhibitors in 9.6% of the patients.

  7. PROACTIVE DEFENSE FOR EVOLVING SUPPLY CHAIN COUNTERFEITING

    Science.gov (United States)

    2015-12-01

    counterfeiters who reprocess the parts and sell them as original products .4 Information Communication Technology (ICT): refers to the information and...company that originally built a product .9 Supply Chain Risk: risks that arise from the confidentiality, integrity, or availability of information...four different graduate schools spread across 22 years of marriage. For the past few years, she has endured a life with an " absentee husband" who

  8. Quality of Life and Adherence to Antiretroviral Drugs | Mweemba ...

    African Journals Online (AJOL)

    Efficacy of antiretroviral treatment in HIV/AIDS is showing inhibition of viral replication and reduction of viral load to a point where viral particles are undetectable in the blood of infected individuals. ... Quality of life is a complex broad ranging multidimensional concept defined in terms of individual's subjective experiences.

  9. Inkjet Printing Based Mono-layered Photonic Crystal Patterning for Anti-counterfeiting Structural Colors

    Science.gov (United States)

    Nam, Hyunmoon; Song, Kyungjun; Ha, Dogyeong; Kim, Taesung

    2016-01-01

    Photonic crystal structures can be created to manipulate electromagnetic waves so that many studies have focused on designing photonic band-gaps for various applications including sensors, LEDs, lasers, and optical fibers. Here, we show that mono-layered, self-assembled photonic crystals (SAPCs) fabricated by using an inkjet printer exhibit extremely weak structural colors and multiple colorful holograms so that they can be utilized in anti-counterfeit measures. We demonstrate that SAPC patterns on a white background are covert under daylight, such that pattern detection can be avoided, but they become overt in a simple manner under strong illumination with smartphone flash light and/or on a black background, showing remarkable potential for anti-counterfeit techniques. Besides, we demonstrate that SAPCs yield different RGB histograms that depend on viewing angles and pattern densities, thus enhancing their cryptographic capabilities. Hence, the structural colorations designed by inkjet printers would not only produce optical holograms for the simple authentication of many items and products but also enable a high-secure anti-counterfeit technique. PMID:27487978

  10. Is infant exposure to antiretroviral drugs during breastfeeding quantitatively important? A systematic review and meta-analysis of pharmacokinetic studies

    Science.gov (United States)

    Waitt, Catriona John; Garner, Paul; Bonnett, Laura Jayne; Khoo, Saye Hock; Else, Laura Jayne

    2015-01-01

    Objectives The objectives of this study were to summarize antiretroviral drug concentrations in breast milk (BM) and exposure of breast-fed infants. Methods This was a systematic review of pharmacokinetic studies of HIV-positive women taking antiretrovirals that measured drugs in BM. The quality of pharmacokinetic and laboratory methods was assessed using pre-defined criteria. Pooled ratios and 95% CIs were calculated using the generalized inverse variance method and heterogeneity was estimated by the I2 statistic. PubMed Central, SCOPUS and LactMed databases were searched. No date or language restrictions were applied. Searches were conducted up to 10 November 2014. Clinical relevance was estimated by comparing ingested dose with the recommended therapeutic dose for each drug. Results Twenty-four studies were included. There was substantial variability in the clinical and laboratory methods used and in reported results. Relative to maternal plasma (MP), NRTIs accumulate in BM, with BM : MP ratios (95% CI estimates) from 0.89 to 1.21 (14 studies, 1159 paired BM and MP samples). NNRTI estimates were from 0.71 to 0.94 (17 studies, 965 paired samples) and PI estimates were from 0.17 to 0.21 (8 studies, 477 paired samples). Relative to the recommended paediatric doses, a breast-fed infant may ingest 8.4% (95% CI 1.9–15.0), 12.5% (95% CI 2.6–22.3) and 1.1% (95% CI 0–3.6) of lamivudine, nevirapine and efavirenz, respectively, via BM. Conclusions Transfer to untreated infants appears quantitatively important for some NRTIs and NNRTIs. The pharmacokinetic methods varied widely and we propose standards for the design, analysis and reporting of future pharmacokinetic studies of drug transfer during breastfeeding. PMID:25858354

  11. Louis Vuitton in the bazaar: Negotiating the value of counterfeit goods in Shanghai's Xiangyang market

    OpenAIRE

    Hansen, Gard Hopsdal; Møller, Henrik Kloppenborg

    2017-01-01

    Abstract: Much work on counterfeiting takes the perspective of brand holders and focuses on strategies for restricting the infringement of their intellectual property rights (IPR). This article takes a different approach. Based on long-term ethnographic fieldwork in a market bazaar in Shanghai, the article examines the way in which market participants negotiate the value of counterfeit goods. Brand holders attempt to control the valuation of branded goods, which are usually traded in fixed-pr...

  12. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2016 Recommendations of the International Antiviral Society-USA Panel.

    Science.gov (United States)

    Günthard, Huldrych F; Saag, Michael S; Benson, Constance A; del Rio, Carlos; Eron, Joseph J; Gallant, Joel E; Hoy, Jennifer F; Mugavero, Michael J; Sax, Paul E; Thompson, Melanie A; Gandhi, Rajesh T; Landovitz, Raphael J; Smith, Davey M; Jacobsen, Donna M; Volberding, Paul A

    2016-07-12

    New data and therapeutic options warrant updated recommendations for the use of antiretroviral drugs (ARVs) to treat or to prevent HIV infection in adults. To provide updated recommendations for the use of antiretroviral therapy in adults (aged ≥18 years) with established HIV infection, including when to start treatment, initial regimens, and changing regimens, along with recommendations for using ARVs for preventing HIV among those at risk, including preexposure and postexposure prophylaxis. A panel of experts in HIV research and patient care convened by the International Antiviral Society-USA reviewed data published in peer-reviewed journals, presented by regulatory agencies, or presented as conference abstracts at peer-reviewed scientific conferences since the 2014 report, for new data or evidence that would change previous recommendations or their ratings. Comprehensive literature searches were conducted in the PubMed and EMBASE databases through April 2016. Recommendations were by consensus, and each recommendation was rated by strength and quality of the evidence. Newer data support the widely accepted recommendation that antiretroviral therapy should be started in all individuals with HIV infection with detectable viremia regardless of CD4 cell count. Recommended optimal initial regimens for most patients are 2 nucleoside reverse transcriptase inhibitors (NRTIs) plus an integrase strand transfer inhibitor (InSTI). Other effective regimens include nonnucleoside reverse transcriptase inhibitors or boosted protease inhibitors with 2 NRTIs. Recommendations for special populations and in the settings of opportunistic infections and concomitant conditions are provided. Reasons for switching therapy include convenience, tolerability, simplification, anticipation of potential new drug interactions, pregnancy or plans for pregnancy, elimination of food restrictions, virologic failure, or drug toxicities. Laboratory assessments are recommended before treatment, and

  13. Medicines informal market in Congo, Burundi and Angola: counterfeit and sub-standard antimalarials

    Directory of Open Access Journals (Sweden)

    Bertocchi Paola

    2007-02-01

    Full Text Available Abstract Background The presence of counterfeits and sub-standards in African medicines market is a dramatic problem that causes many deaths each year. The increase of the phenomenon of pharmaceutical counterfeiting is due to the rise of the illegal market and to the impossibility to purchase branded high cost medicines. Methods In this paper the results of a quality control on antimalarial tablet samples purchased in the informal market in Congo, Burundi and Angola are reported. The quality control consisted in the assay of active substance by means of validated liquid chromatographic methods, uniformity of mass determination, disintegration and dissolution tests. Moreover, a general evaluation on label and packaging characteristics was performed. Results The results obtained on thirty antimalarial tablet samples containing chloroquine, quinine, mefloquine, sulphadoxine and pyrimethamine showed the presence of different kinds of problems: a general problem concerning the packaging (loose tablets, packaging without Producer name, Producer Country and sometimes without expiry date; low content of active substance (in one sample; different, non-declared, active substance (in one sample; sub-standard technological properties and very low dissolution profiles (in about 50% of samples. This last property could affect the bioavailability and bioequivalence in comparison with branded products and could be related to the use of different excipients in formulation or bad storage conditions. Conclusion This paper evidences that the most common quality problem in the analysed samples appears to be the low dissolution profile. Here it is remarked that the presence of the right active substance in the right quantity is not a sufficient condition for a good quality drug. Dissolution test is not less important in a quality control and often evidences in vitro possible differences in therapeutic efficacy among drugs with the same active content. Dissolution

  14. 3-12 Detection and Management of Adverse Drug React

    African Journals Online (AJOL)

    MINA SAN

    Detection and Management of Adverse Drug Reactions Related to Antiretroviral Drugs among. HIV/AIDS Patients in Kiambu ... of various adverse drug reactions associated with antiretroviral drugs occurring in patients attending Comprehensive Care .... educational level, perception of ADRs, knowledge of ADRs, detection ...

  15. Perceived stigma and highly active antiretroviral treatment ...

    African Journals Online (AJOL)

    Perceived stigma and highly active antiretroviral treatment adherence among persons living with HIV/AIDS in the University of Port Harcourt Teaching Hospital. ... Data on socio-demographic characteristics, stigma and adherence to drug regimen were collected using a validated self-administered questionnaire. Data were ...

  16. Discriminant function for classification of genuine and counterfeit ...

    African Journals Online (AJOL)

    Findings of the research revealed that the naira notes are to be classified as counterfeit or genuine according to the model: Z = 440.3007X - 858.8366Y + 147.5228Z such that Z > Z0 where Z0 is the end point of classification. Hotelling's T2 and Mahalanobis quantity were also computed. The test result showed that ...

  17. Challenges and perspectives of compliance with pediatric antiretroviral therapy in Sub-Saharan Africa.

    Science.gov (United States)

    Dahourou, D L; Leroy, V

    2017-12-01

    More than 3 million children aged less than 15years are infected with HIV worldwide, mainly in Sub-Saharan Africa. The survival of HIV-infected children depends on their access to antiretroviral therapy whose success mainly depends on a good life-long compliance with antiretroviral therapy. Given its complexity and specificity, assessment and monitoring of pediatric compliance with antiretroviral therapy is a major challenge. There is no consensus on a gold standard for monitoring compliance with antiretroviral therapy. Compliance is also influenced by many factors related to the child, the caregiver, the healthcare staff, the healthcare system, and antiretroviral drugs. This review aimed to assess scientific knowledge on pediatric compliance with antiretroviral therapy in Sub-Saharan Africa, and to identify areas for future interventions to improve compliance. Good compliance is essential to achieve the "90% coverage of children on antiretroviral therapy" gold standard of the World Health Organization, and to eliminate HIV infection by 2030. Copyright © 2017. Published by Elsevier SAS.

  18. Global trends in antiretroviral resistance in treatment-naive individuals with HIV after rollout of antiretroviral treatment in resource-limited settings: a global collaborative study and meta-regression analysis.

    Science.gov (United States)

    Gupta, Ravindra K; Jordan, Michael R; Sultan, Binta J; Hill, Andrew; Davis, Daniel H J; Gregson, John; Sawyer, Anthony W; Hamers, Raph L; Ndembi, Nicaise; Pillay, Deenan; Bertagnolio, Silvia

    2012-10-06

    The emergence and spread of high levels of HIV-1 drug resistance in resource-limited settings where combination antiretroviral treatment has been scaled up could compromise the effectiveness of national HIV treatment programmes. We aimed to estimate changes in the prevalence of HIV-1 drug resistance in treatment-naive individuals with HIV since initiation of rollout in resource-limited settings. We did a systematic search for studies and conference abstracts published between January, 2001, and July, 2011, and included additional data from the WHO HIV drug resistance surveillance programme. We assessed the prevalence of drug-resistance mutations in untreated individuals with respect to time since rollout in a series of random-effects meta-regression models. Study-level data were available for 26,102 patients from sub-Saharan Africa, Asia, and Latin America. We recorded no difference between chronic and recent infection on the prevalence of one or more drug-resistance mutations for any region. East Africa had the highest estimated rate of increase at 29% per year (95% CI 15 to 45; p=0·0001) since rollout, with an estimated prevalence of HIV-1 drug resistance at 8 years after rollout of 7·4% (4·3 to 12·7). We recorded an annual increase of 14% (0% to 29%; p=0·054) in southern Africa and a non-significant increase of 3% (-0·9 to 16; p=0·618) in west and central Africa. There was no change in resistance over time in Latin America, and because of much country-level heterogeneity the meta-regression analysis was not appropriate for Asia. With respect to class of antiretroviral, there were substantial increases in resistance to non-nucleoside reverse transcriptase inhibitors (NNRTI) in east Africa (36% per year [21 to 52]; pAfrica (23% per year [7 to 42]; p=0·0049). No increase was noted for the other drug classes in any region. Our findings suggest a significant increase in prevalence of drug resistance over time since antiretroviral rollout in regions of sub

  19. Impact of HIV-1 subtype and antiretroviral therapy on protease and reverse transcriptase genotype: results of a global collaboration.

    Directory of Open Access Journals (Sweden)

    Rami Kantor

    2005-04-01

    Full Text Available The genetic differences among HIV-1 subtypes may be critical to clinical management and drug resistance surveillance as antiretroviral treatment is expanded to regions of the world where diverse non-subtype-B viruses predominate.To assess the impact of HIV-1 subtype and antiretroviral treatment on the distribution of mutations in protease and reverse transcriptase, a binomial response model using subtype and treatment as explanatory variables was used to analyze a large compiled dataset of non-subtype-B HIV-1 sequences. Non-subtype-B sequences from 3,686 persons with well characterized antiretroviral treatment histories were analyzed in comparison to subtype B sequences from 4,769 persons. The non-subtype-B sequences included 461 with subtype A, 1,185 with C, 331 with D, 245 with F, 293 with G, 513 with CRF01_AE, and 618 with CRF02_AG. Each of the 55 known subtype B drug-resistance mutations occurred in at least one non-B isolate, and 44 (80% of these mutations were significantly associated with antiretroviral treatment in at least one non-B subtype. Conversely, of 67 mutations found to be associated with antiretroviral therapy in at least one non-B subtype, 61 were also associated with antiretroviral therapy in subtype B isolates.Global surveillance and genotypic assessment of drug resistance should focus primarily on the known subtype B drug-resistance mutations.

  20. Nanotag luminescent fingerprint anti-counterfeiting technology

    DEFF Research Database (Denmark)

    Radziwon, Michal Jędrzej; Rubahn, Horst-Günter; Johansen, Stefan

    2012-01-01

    We describe a method to fabricate, transfer and validate via image processing nanofibre- based, unique security marks (“nanotags”) for anti-counterfeiting purposes. Epitaxial surface growth of oligophenylenes on a heated muscovite mica crystal results in a thin film of mutually aligned nanofibres....... This fingerprint can be transferred on an adhesive tape as a label of a product, imaged using low magnification microscopy, digitalised and stored in a database. Infrared surface heating, enforced cooling and load lock transfer makes the fabrication process fast and scalable to mass production....

  1. 78 FR 35262 - Detection and Avoidance of Counterfeit Electronic Parts

    Science.gov (United States)

    2013-06-12

    ... experts and interested parties in Government and the private sector regarding the electronic parts... Avoidance of Counterfeit Electronic Parts AGENCY: Defense Acquisition Regulations System, Department of... interested parties in Government and the private sector about the requirements for detection and avoidance of...

  2. Cause-Specific Mortality in HIV-Positive Patients Who Survived Ten Years after Starting Antiretroviral Therapy

    DEFF Research Database (Denmark)

    Trickey, Adam; May, Margaret T; Vehreschild, Jorg-Janne

    2016-01-01

    OBJECTIVES: To estimate mortality rates and prognostic factors in HIV-positive patients who started combination antiretroviral therapy between 1996-1999 and survived for more than ten years. METHODS: We used data from 18 European and North American HIV cohort studies contributing to the Antiretro......OBJECTIVES: To estimate mortality rates and prognostic factors in HIV-positive patients who started combination antiretroviral therapy between 1996-1999 and survived for more than ten years. METHODS: We used data from 18 European and North American HIV cohort studies contributing...... to the Antiretroviral Therapy Cohort Collaboration. We followed up patients from ten years after start of combination antiretroviral therapy. We estimated overall and cause-specific mortality rate ratios for age, sex, transmission through injection drug use, AIDS, CD4 count and HIV-1 RNA. RESULTS: During 50,593 person...... years 656/13,011 (5%) patients died. Older age, male sex, injecting drug use transmission, AIDS, and low CD4 count and detectable viral replication ten years after starting combination antiretroviral therapy were associated with higher subsequent mortality. CD4 count at ART start did not predict...

  3. NIR spectrometry for counterfeit drug detection - A feasibility study

    DEFF Research Database (Denmark)

    Rodionova, O.Y.; Houmøller, Lars P.; Pomerantsev, A.L.

    2005-01-01

    for mathematical data processing for false drugs detection is demonstrated. Also, multivariate hyperspectral image analysis is applied providing additional diagnostic information. Hyperspectral imaging is becoming a useful diagnostic tool for identifying non-homogeneous spatial regions of drug formulation. Two...... types of drugs are used to demonstrate the applicability of these approaches....

  4. Effects of antiretroviral therapy on immunity in patients infected with HIV.

    Science.gov (United States)

    Feola, D J; Thornton, A C; Garvy, B A

    2006-01-01

    Drug therapy for human immunodeficiency virus (HIV) is highly effective in suppressing viral replication and restoring immune function in patients with HIV. However, this same treatment can also be associated with immunotoxicity. For example, zidovudine and various other antiretroviral agents are capable of causing bone marrow suppression. Agents used to treat opportunistic infections in these individuals, including ganciclovir, foscarnet, and sulfamethoxazole-trimethoprim, can cause additional hematotoxicity. Drug-drug interactions must also be considered and managed in order to control iatrogenic causes of immunotoxicity. In this review, we examine the normal immune response to HIV, and the benefits of antiretroviral therapy in prolonging immune function. We then discuss immune-related adverse effects of drugs used to treat HIV and the opportunistic infections that are common among these patients. Finally, we address in vitro, animal, and clinical evidence of toxicity associated with various combination use of these agents.

  5. The effects of intermittent, CD4-guided antiretroviral therapy on body composition and metabolic parameters

    NARCIS (Netherlands)

    Martinez, Esteban; Visnegarwala, Fehmida; Grund, Birgit; Thomas, Avis; Gibert, Cynthia; Shlay, Judith; Drummond, Fraser; Pearce, Daniel; Edwards, Simon; Reiss, Peter; El-Sadr, Wafaa; Carr, Andrew

    2010-01-01

    Objective: To assess the effects of decreased antiretroviral therapy exposure on body fat and metabolic parameters. Design: Substudy of the Strategies for Management of Anti-Retroviral Therapy study, in which participants were randomized to intermittent CD4-guided [Drug Conservation (DC) group] or

  6. Drug-resistant tuberculosis among HIV-infected patients starting antiretroviral therapy in Durban, South Africa.

    Directory of Open Access Journals (Sweden)

    Jeffrey K Hom

    Full Text Available To estimate the prevalence of drug-resistant tuberculosis (TB and describe the resistance patterns in patients commencing antiretroviral therapy (ART in an HIV clinic in Durban, South Africa.Cross-sectional cohort study.Consecutive HIV-infected adults (≥ 18y/o initiating HIV care were enrolled from May 2007-May 2008, regardless of signs or symptoms of active TB. Prior TB history and current TB treatment status were self-reported. Subjects expectorated sputum for culture (MGIT liquid and 7H11 solid medium. Positive cultures were tested for susceptibility to first- and second-line anti-tuberculous drugs. The prevalence of drug-resistant TB, stratified by prior TB history and current TB treatment status, was assessed.1,035 subjects had complete culture results. Median CD4 count was 92/µl (IQR 42-150/µl. 267 subjects (26% reported a prior history of TB and 210 (20% were receiving TB treatment at enrollment; 191 (18% subjects had positive sputum cultures, among whom the estimated prevalence of resistance to any antituberculous drug was 7.4% (95% CI 4.0-12.4. Among those with prior TB, the prevalence of resistance was 15.4% (95% CI 5.9-30.5 compared to 5.2% (95% CI 2.1-8.9 among those with no prior TB. 5.1% (95% CI 2.4-9.5 had rifampin or rifampin plus INH resistance.The prevalence of TB resistance to at least one drug was 7.4% among adults with positive TB cultures initiating ART in Durban, South Africa, with 5.1% having rifampin or rifampin plus INH resistance. Improved tools for diagnosing TB and drug resistance are urgently needed in areas of high HIV/TB prevalence.

  7. Identification of Chinese Caterpillar Medicinal Mushroom, Ophiocordyceps sinensis (Ascomycetes) from Counterfeit Species.

    Science.gov (United States)

    Zhang, Wenjuan; Zhang, Xiaolong; Li, Minghua; Shi, Yan; Zhang, Ping; Cheng, Xian-Long; Wei, Feng; Ma, Shuangcheng

    2017-01-01

    Ophiocordyceps sinensis is a valuable traditional Chinese medicine with a high market price. In this study, a polymerase chain reaction-restriction fragment-length polymorphism (PCR-RFLP) method based on 2 enzymes was developed to distinguish O. sinensis from 6 common counterfeit species. To verify the applicability of this method, we experimentally tested O. sinensis organisms, tablet preparations made from O. sinensis, and cultured mycelia isolated from O. sinensis. To validate the results from this PCR-RFLP method, all real samples were identified by internal transcribed spacer sequencing. This is, to our knowledge, the first time the PCR-RFLP method has been applied to identify O. sinensis. The selection of 2 restrictive enzymes for identification dramatically improved the accuracy and efficiency of this method. It is the great advantage of this method that sampling from either of 2 parts of O. sinensis-the fruiting body or the caterpillar body-would not cause any difference in the final experimental results. Therefore, this method is not only feasible for testing crude drugs of O. sinensis but it is also useful when the crude drugs are broken down into powder or made into tablets, demonstrating the promising prospect of application in quality control.

  8. Use of NDE Techniques for Compliance Verification of Suspect Counterfeit EEE Parts

    Data.gov (United States)

    National Aeronautics and Space Administration — Genuine microelectronics components are critical to NASA for Human Rating Requirement (HRR) for Manned Follow-On Vehicles and for planetary missions.  Counterfeited...

  9. Traceability and Risk Analysis Strategies for Addressing Counterfeit Electronics in Supply Chains for Complex Systems.

    Science.gov (United States)

    DiMase, Daniel; Collier, Zachary A; Carlson, Jinae; Gray, Robin B; Linkov, Igor

    2016-10-01

    Within the microelectronics industry, there is a growing concern regarding the introduction of counterfeit electronic parts into the supply chain. Even though this problem is widespread, there have been limited attempts to implement risk-based approaches for testing and supply chain management. Supply chain risk management tends to focus on the highly visible disruptions of the supply chain instead of the covert entrance of counterfeits; thus counterfeit risk is difficult to mitigate. This article provides an overview of the complexities of the electronics supply chain, and highlights some gaps in risk assessment practices. In particular, this article calls for enhanced traceability capabilities to track and trace parts at risk through various stages of the supply chain. Placing the focus on risk-informed decision making through the following strategies is needed, including prioritization of high-risk parts, moving beyond certificates of conformance, incentivizing best supply chain management practices, adoption of industry standards, and design and management for supply chain resilience. © 2016 Society for Risk Analysis.

  10. Guidelines for antiretroviral therapy in adults

    Directory of Open Access Journals (Sweden)

    G Meintjes

    2012-08-01

    Full Text Available These guidelines are intended as an update to those published in the Southern African Journal of HIV Medicine in January 2008. Since the release of the previous guidelines, the scale-up of antiretroviral therapy (ART in Southern Africa has continued to grow. Cohort studies from the region show excellent clinical outcomes; however, ART is still being started late (in advanced disease, resulting in relatively high early mortality rates. New data on antiretroviral (ARV tolerability in the region and several new ARV drugs have become available. Although currently few in number, some patients in the region are failing protease inhibitor (PI-based second-line regimens. To address this, guidelines on third-line (or ‘salvage’ therapy have been expanded.

  11. Biodegradable Microparticles for Simultaneous Detection of Counterfeit and Deteriorated Edible Products

    NARCIS (Netherlands)

    Rehor, Ivan; van Vreeswijk, Sophie; Vermonden, Tina; Hennink, Wim E.; Kegel, Willem K.; Eral, Huseyin Burak

    2017-01-01

    In an era of globalized trade relations where food and pharmaceutical products cross borders effortlessly, consumers face counterfeit and deteriorated products at elevated rates. This paper presents multifunctional, biodegradable hydrogel microparticles that can provide information on the

  12. Regional changes over time in initial virologic response rates to combination antiretroviral therapy across Europe

    DEFF Research Database (Denmark)

    Bannister, Wendy P; Kirk, Ole; Gatell, Jose M

    2006-01-01

    BACKGROUND: Changes in virologic response to initial combination antiretroviral therapy (cART) over calendar time may indicate improvements in cART or emergence of primary resistance. Regional variations may identify differences in available antiretroviral drugs or patient management. METHODS: Vi...... rates Udgivelsesdato: 2006/6...

  13. Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial.

    Science.gov (United States)

    Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San; Hart, Stephen; Wallis, Carole; Morgado, Mariza G; Saravanan, Shanmugam; Tripathy, Srikanth; Hovind, Laura; Piwowar-Manning, Estelle; Sabin, Devin; McCauley, Marybeth; Gamble, Theresa; Zhang, Xinyi C; Eron, Joseph J; Gallant, Joel E; Kumwenda, Johnstone; Makhema, Joseph; Kumarasamy, Nagalingeswaran; Chariyalertsak, Suwat; Hakim, James; Badal-Faesen, Sharlaa; Akelo, Victor; Hosseinipour, Mina C; Santos, Breno R; Godbole, Sheela V; Pilotto, Jose H; Grinsztejn, Beatriz; Panchia, Ravindre; Mayer, Kenneth H; Chen, Ying Q; Cohen, Myron S; Eshleman, Susan H

    2016-07-01

    Early initiation of antiretroviral treatment (ART) reduces HIV transmission and has health benefits. HIV drug resistance can limit treatment options and compromise use of ART for HIV prevention. We evaluated drug resistance in 85 participants in the HIV Prevention Trials Network 052 trial who started ART at CD4 counts of 350-550 cells per cubic millimeter and failed ART by May 2011; 8.2% had baseline resistance and 35.3% had resistance at ART failure. High baseline viral load and less education were associated with emergence of resistance at ART failure. Resistance at ART failure was observed in 7 of 8 (87.5%) participants who started ART at lower CD4 cell counts.

  14. Efficacy and durability of nevirapine in antiretroviral drug naive patients

    NARCIS (Netherlands)

    Lange, Joep M. A.

    2003-01-01

    Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was first reported in the scientific literature in 1990. Varying doses of nevirapine (NVP) and a number of regimens containing this NNRTI have been studied in antiretroviral (ARV) naive patients. Four key studies have

  15. Delays by people living with HIV/AIDS in accessing antiretroviral ...

    African Journals Online (AJOL)

    Objective: To understand, by qualitative enquiry, the underlying reasons and narratives ... denial, practical clinic constraints and appropriate types of health education. Keywords: qualitative research, delays, access, antiretroviral drugs, ARVs ...

  16. Anti-retroviral therapy induced diabetes in a Nigerian | Bakari ...

    African Journals Online (AJOL)

    African Health Sciences ... Background:Anti-retroviral therapy (ART) using Highly Active Anti-retroviral Therapy (HAART) has led to ... HIV infected individuals on one hand, and side effects of chronic administration of these drugs on the other.

  17. A first-line antiretroviral therapy-resistant HIV patient with rhinoentomophthoromycosis

    Directory of Open Access Journals (Sweden)

    Rachita Dhurat

    2018-01-01

    Full Text Available The Conidiobolus coronatus-related rhinoentomophthoromycosis in immunocompetent and immunocompromised (HIV negative individuals has been treated successfully with antifungal drugs. However, C. coronatus infections in first-line antiretroviral therapy (ART-resistant (HIV infected individuals particularly with rhinoentomophthoromycosis have not been reported previously. Here, we describe a case of itraconazole non-responding rhinoentomophthoromycosis in an HIV-infected patient with first-line antiretroviral (ART drug resistance which was successfully managed through systematic diagnostic and therapeutic approaches in dermatologic setting. A 32-year-old HIV-1-infected man presented with painless swelling, nasal redness and respiratory difficulty. The patient was receiving first-line ART and had a history of traumatic injury before the onset of nasopharyngeal manifestations. The patient's previous history included oral candidiasis and pulmonary tuberculosis.

  18. The Impact of Non-Antiretroviral Polypharmacy on the Continuity of Antiretroviral Therapy (ART) Among HIV Patients.

    Science.gov (United States)

    Krentz, Hartmut B; Gill, M John

    2016-01-01

    Improved survival achieved by many patients with HIV/AIDS has complicated their medical care as increasing numbers of co-morbidities leads to polypharmacy, increased pill burdens, and greater risks of drug-drug interactions potentially compromising antiretroviral treatment (ART). We examined the impact of non-antiretroviral polypharmacy on ART for all adults followed at the Southern Alberta Clinic, Calgary, Canada. Polypharmacy was defined as ≥5 daily medications. We compared the impact of polypharmacy on continuous (i.e., remaining on same ART for ≥6 months) vs. non-continuous (i.e., discontinuing or switching ART) ART dosing frequency, number of ART pills, number of non-ART medications, and age. Of 1190 (89.5%) patients on ART, 95% were on three-drug regimens, 63.9% on QD ART, and 62% ≥3 ART pills daily; 32.2% were experiencing polypharmacy. Polypharmacy was associated with lower CD4, AIDS, >180 months living with HIV, higher numbers of ART pills, and older age (all p ART. Polypharmacy increased the risk for non-continuous ART (36.8% vs. 30.0%; p ART increased with daily ART pill count but not increased age. Non-adherence and adverse effects accounted for the majority of non-continuous ART. We found a strong association between polypharmacy and non-continuous ART, potentially leading to effective ART being compromised. Collaborative approaches are needed to anticipate the negative impacts of polypharmacy.

  19. Antiretroviral neuropenetration scores better correlate with cognitive performance of HIV-infected patients after accounting for drug susceptibility.

    Science.gov (United States)

    Fabbiani, Massimiliano; Grima, Pierfrancesco; Milanini, Benedetta; Mondi, Annalisa; Baldonero, Eleonora; Ciccarelli, Nicoletta; Cauda, Roberto; Silveri, Maria C; De Luca, Andrea; Di Giambenedetto, Simona

    2015-01-01

    The aim of the study was to explore how viral resistance and antiretroviral central nervous system (CNS) penetration could impact on cognitive performance of HIV-infected patients. We performed a multicentre cross-sectional study enrolling HIV-infected patients undergoing neuropsychological testing, with a previous genotypic resistance test on plasma samples. CNS penetration-effectiveness (CPE) scores and genotypic susceptibility scores (GSS) were calculated for each regimen. A composite score (CPE-GSS) was then constructed. Factors associated with cognitive impairment were investigated by logistic regression analysis. A total of 215 patients were included. Mean CPE was 7.1 (95% CI 6.9, 7.3) with 206 (95.8%) patients showing a CPE≥6. GSS correction decreased the CPE value in 21.4% (mean 6.5, 95% CI 6.3, 6.7), 26.5% (mean 6.4, 95% CI 6.1, 6.6) and 24.2% (mean 6.4, 95% CI 6.2, 6.6) of subjects using ANRS, HIVDB and REGA rules, respectively. Overall, 66 (30.7%) patients were considered cognitively impaired. No significant association could be demonstrated between CPE and cognitive impairment. However, higher GSS-CPE was associated with a lower risk of cognitive impairment (CPE-GSSANRS odds ratio 0.75, P=0.022; CPE-GSSHIVDB odds ratio 0.77, P=0.038; CPE-GSSREGA odds ratio 0.78, P=0.038). Overall, a cutoff of CPE-GSS≥5 seemed the most discriminatory according to each different interpretation system. GSS-corrected CPE score showed a better correlation with neurocognitive performance than the standard CPE score. These results suggest that antiretroviral drug susceptibility, besides drug CNS penetration, can play a role in the control of HIV-associated neurocognitive disorders.

  20. Can voluntary pooled procurement reduce the price of antiretroviral drugs? a case study of Efavirenz.

    Science.gov (United States)

    Kim, Sung Wook; Skordis-Worrall, Jolene

    2017-05-01

    : A number of strategies have aimed to assist countries in procuring antiretroviral therapy (ARV) at lower prices. In 2009, as the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) commenced a voluntary pooled procurement scheme, however, the impact of the scheme on ARV prices remains uncertain. This study aims to estimate the effect of VPP on drug prices using Efavirenz as a case study. This analysis uses WHO Global price report mechanism (GPRM) data from 2004 to 2013. Due to the highly skewed distribution of drug Prices, a generalized linear model (GLM) was used to conduct a difference-in-difference estimation of drug price changes over time. These analyses found that voluntary pooled procurement reduced both the ex-works price of generic Efavirenz and the incoterms price by 16.2 and 19.1%, respectively ( P <  0.001) in both cases). The year dummies were also statistically significant from 2006 to 2013 ( P <  0.001), indicating a strong decreasing trend in the price of Efavirenz over that period. Voluntary pooled procurement significantly reduced the price of 600 mg generic Efavirenz between 2009 and 2013. Voluntary pooled procurement therefore offers a potentially effective strategy for the reduction in HIV drug prices and the improvement of technical efficiency in HIV programming. Further work is required to establish if these findings hold also for other drugs. © The Author 2017. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  1. Antiretroviral treatment switch strategies for lowering the costs of antiretroviral therapy in subjects with suppressed HIV-1 viremia in Spain

    Directory of Open Access Journals (Sweden)

    Llibre JM

    2013-05-01

    Full Text Available Josep M Llibre,1,2 Gloria Cardona,3 José R Santos,2 Angels Andreu,3 Josep O Estrada,4 Jordi Ara,4 Xavier Bonafont,3 Bonaventura Clotet1,21HIV Unit, University Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; 2Lluita contra la SIDA Foundation, Badalona, Barcelona, Spain; 3Hospital Pharmacy, University Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain; 4Hospital Management, University Hospital Germans Trias i Pujol, Badalona, Barcelona, SpainBackground: The current economic recession in European countries has forced governments to design emergency measures to reduce spending on drugs, including antiretroviral therapy (ART. Switching antiretroviral drugs for others that have the same efficacy and safety profile at a lower cost (cost-reduction measures, CRM could prove to be a valid means of generating savings.Methods: Descriptive study of prospective consensus-based CRM undertaken in 2011 in a Catalonian hospital HIV unit among patients with prolonged plasma HIV-1 RNA <50 copies/mL.Results: During the study period, we made 673 switches (87.5% more than the previous year, of which 378 (56.2% were CRM (16% of all patients treated, leading to a savings of €87,410/month. Switching tenofovir/emtricitabine for abacavir/lamivudine was the most common CRM (129, 31.3%, followed by simplification to boosted protease inhibitor monotherapy (bPImono, 102, 26%. The CRM that generated the greatest saving were switching to bPImono (38%, withdrawal or replacement of raltegravir (24%, switching tenofovir/emtricitabine for abacavir/lamivudine (13%, and switching to nevirapine (5%. Cost savings with CRM were slightly higher than those achieved with medication paid for by clinical trial sponsors (€80,333/month or through discount arrangements (€76,389/month.Conclusion: Proactively switching antiretroviral therapy in selected treated patients with sustained virological suppression can generate significant cost savings in pharmacy spending in

  2. Payment for antiretroviral drugs is associated with a higher rate of patients lost to follow-up than those offered free-of-charge therapy in Nairobi, Kenya

    NARCIS (Netherlands)

    Zachariah, R.; van Engelgem, I.; Massaquoi, M.; Kocholla, L.; Manzi, M.; Suleh, A.; Phillips, M.; Borgdorff, M.

    2008-01-01

    This retrospective analysis of routine programme data from Mbagathi District Hospital, Nairobi, Kenya shows the difference in rates of loss to follow-up between a cohort that paid 500 shillings/month (approximately US$7) for antiretroviral drugs (ART) and one that received medication free of charge.

  3. Perinatal genotoxicity and carcinogenicity of anti-retroviral nucleoside analog drugs

    International Nuclear Information System (INIS)

    Poirier, Miriam C.; Olivero, Ofelia A.; Walker, Dale M.; Walker, Vernon E.

    2004-01-01

    The current worldwide spread of the human immunodeficiency virus-1 (HIV-1) to the heterosexual population has resulted in approximately 800 000 children born yearly to HIV-1-infected mothers. In the absence of anti-retroviral intervention, about 25% of the approximately 7000 children born yearly to HIV-1-infected women in the United States are HIV-1 infected. Administration of zidovudine (AZT) prophylaxis during pregnancy reduces the rate of infant HIV-1 infection to approximately 7%, and further reductions are achieved with the addition of lamivudine (3TC) in the clinical formulation Combivir. Whereas clinically this is a remarkable achievement, AZT and 3TC are DNA replication chain terminators known to induce various types of genotoxicity. Studies in rodents have demonstrated AZT-DNA incorporation, HPRT mutagenesis, telomere shortening, and tumorigenicity in organs of fetal mice exposed transplacentally to AZT. In monkeys, both AZT and 3TC become incorporated into the DNA from multiple fetal organs taken at birth after administration of human-equivalent protocols to pregnant dams during gestation, and telomere shortening has been found in monkey fetuses exposed to both drugs. In human infants, AZT-DNA and 3TC-DNA incorporation as well as HPRT and GPA mutagenesis have been documented in cord blood from infants exposed in utero to Combivir. In infants of mice, monkeys, and humans, levels of AZT-DNA incorporation were remarkably similar, and in newborn mice and humans, mutation frequencies were also very similar. Given the risk-benefit ratio, these highly successful drugs will continue to be used for prevention of vertical viral transmission, however evidence of genotoxicity in mouse and monkey models and in the infants themselves would suggest that exposed children should be followed well past adolescence for early detection of potential cancer hazard

  4. Coconut Oil Extract Mitigates Testicular Injury Following Adjuvant Treatment with Antiretroviral Drugs.

    Science.gov (United States)

    Ogedengbe, Oluwatosin O; Jegede, Ayoola I; Onanuga, Ismail O; Offor, Ugochukwu; Naidu, Edwin Cs; Peter, Aniekan I; Azu, Onyemaechi O

    2016-10-01

    Increased access to highly active antiretroviral therapy (HAART) has made the management of drug toxicities an increasingly crucial component of HIV. This study investigated the effects of adjuvant use of coconut oil and HAART on testicular morphology and seminal parameters in Sprague- Dawley rats. Twelve adult male Sprague-Dawley rats, weighing 153~169 g were distributed into four groups (A-D) and treated as follows: A served as control (distilled water); B (HAART cocktail- Zidovudine, Lamivudine and Nevirapine); C (HAART + Virgin coconut oil 10 mL/kg) and D (Virgin coconut oil 10 mL/kg). After 56 days of treatment, animals were killed and laparotomy to exercise the epididymis for seminal fluid analyses done whilst testicular tissues were processed for histomorphometric studies. Result showed a significant decline in sperm motility ( P coconut oil + HAART resulted in significant decrease in seminiferous tubular diameter ( P coconut oil alone (which showed normal histoarchitecture levels). While derangements in testicular and seminal fluid parameters occurred following HAART, adjuvant treatment with Virgin coconut oil restored the distortions emanating thereof.

  5. Preventing Wine Counterfeiting by Individual Cork Stopper Recognition Using Image Processing Technologies

    Directory of Open Access Journals (Sweden)

    Valter Costa

    2018-03-01

    Full Text Available Wine counterfeiting is a major problem worldwide. Within this context, an approach to the problem of discerning original wine bottles from forged ones is the use of natural features present in the product, object and/or material (using it “as is”. The proposed application uses the cork stopper as a unique fingerprint, combined with state of the art image processing techniques to achieve individual object recognition and smartphones as the authentication equipment. The anti-counterfeiting scheme is divided into two phases: an enrollment phase, where every bottle is registered in a database using a photo of its cork stopper inside the bottle; and a verification phase, where an end-user/retailer captures a photo of the cork stopper using a regular smartphone, compares the photo with the previously-stored one and retrieves it if the wine bottle was previously registered. To evaluate the performance of the proposed application, two datasets of natural/agglomerate cork stoppers were built, totaling 1000 photos. The worst case results show a 100% precision ratio, an accuracy of 99.94% and a recall of 94.00%, using different smartphones. The perfect score in precision is a promising result, proving that this system can be applied to the prevention of wine counterfeiting and consumer/retailer security when purchasing a wine bottle.

  6. Access to highly active antiretroviral therapy (HAART) for injecting drug users in the WHO European Region 2002-2004

    DEFF Research Database (Denmark)

    Donoghoe, Martin C; Bollerup, Annemarie R; Lazarus, Jeff

    2007-01-01

    Providing equitable access to highly active antiretroviral treatment (HAART) to injecting drug users (IDUs) is both feasible and desirable. Given the evidence that IDUs can adhere to HAART as well as non-IDUs and the imperative to provide universal and equitable access to HIV/AIDS treatment for all...... who need it, here we examine whether IDUs in the 52 countries in the WHO European Region have equitable access to HAART and whether that access has changed over time between 2002 and 2004. We consider regional and country differences in IDU HAART access; examine preliminary data regarding...

  7. Kinetics and Determining Factors of the Virologic Response to Antiretrovirals during Pregnancy

    Directory of Open Access Journals (Sweden)

    Adriana Weinberg

    2009-01-01

    Full Text Available HIV-infected pregnant women with undetectable plasma HIV RNA concentrations at delivery pose a minimal risk of vertical transmission. We studied the kinetics and the determinants of the virologic response to antiretroviral therapy in 117 consecutive pregnancies. Patients who initiated therapy during pregnancy had a VL decrease of 2 and 2.5 log10 after 4 and 24 weeks, respectively. Therapeutic drug monitoring (TDM of the protease inhibitors administered in doses recommended for nonpregnant adults resulted in below-target concentrations in 29%, 35%, and 44% of 1st, 2nd, and 3rd trimester measurements, respectively, but low drug concentrations did not correlate with virologic failure. Demographic characteristics, antiretroviral experience prior to pregnancy, baseline VL, or use of specific antiretrovirals did not affect the virologic response. Adherence to ≥95% of prescribed doses and utilization of psychosocial services were associated with undetectable plasma HIV RNA at delivery. In conclusion, the virologic responses of pregnant and nonpregnant adults share similar charactersitics.

  8. HIV Drug Resistance-Associated Mutations in Antiretroviral Naïve HIV-1-Infected Latin American Children

    Directory of Open Access Journals (Sweden)

    Luis E. Soto-Ramirez

    2010-01-01

    Full Text Available Our goal was to describe the presence of HIV drug resistance among HIV-1-infected, antiretroviral (ARV naïve children and adolescents in Latin America and to examine resistance in these children in relation to drug exposure in the mother. Genotyping was performed on plasma samples obtained at baseline from HIV-1-infected participants in a prospective cohort study in Brazil, Argentina, and Mexico (NISDI Pediatric Study. Of 713 HIV-infected children enrolled, 69 were ARV naïve and eligible for the analysis. At enrollment, mean age was 7.3 years; 81.2% were infected with HIV perinatally. Drug resistance mutations (DRMs were detected in 6 (8.7%; 95% confidence interval 3.1–18.2% ARV-naïve subjects; none of the mothers of these 6 received ARVs during their pregnancies and none of the children received ARV prophylaxis. Reverse transcriptase mutations K70R and K70E were detected in 3 and 2 subjects, respectively; protease mutation I50 V was detected in 1 subject. Three of the 6 children with DRMs initiated ARV therapy during followup, with a good response in 2. The overall rate of primary drug resistance in this pediatric HIV-infected population was low, and no subjects had more than 1 DRM. Mutations associated with resistance to nucleoside reverse transcriptase inhibitors were the most prevalent.

  9. Clinical implications of antiretroviral drug interactions with warfarin: a case-control study.

    Science.gov (United States)

    Esterly, John S; Darin, Kristin M; Gerzenshtein, Lana; Othman, Fidah; Postelnick, Michael J; Scarsi, Kimberly K

    2013-06-01

    Warfarin, a frequently prescribed anticoagulant with a narrow therapeutic index, is susceptible to drug-drug interactions with antiretroviral therapy (ART). This study compared the warfarin maintenance dose (WMD) between patients receiving and not receiving ART and evaluated predictors of warfarin dosage among those on ART. This was a case-control (1:2) study. Cases were HIV-infected patients receiving warfarin and protease inhibitor (PI)- and/or non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART. Controls were randomly selected HIV-uninfected patients receiving warfarin. The WMD was compared between cases and controls and between cases on varying ART regimens. Bivariate comparisons were performed and a linear regression model was developed to identify predictors of WMD. We identified 18 case and 36 control patients eligible for inclusion. Cases were younger than controls (mean age: 45.8 versus 63.1 years, P African American (50.0% versus 22.2%, P=0.04). ART was classified as PI-based (n=9), NNRTI-based (n=7) and PI + NNRTI-based (n=2). The WMD (mean ± SD) differed between cases and controls (8.6  ±  3.4 mg versus 5.1 ± 1.5 mg, P ART regimens (PI: 8.8  ±  4.5 mg; NNRTI: 8.6   ± 1.8 mg; PI + NNRTI: 7.3  ±  3.3 mg; P = 0.86). Race and ritonavir dose were independent predictors of WMD, predicting an increase of 3.9 mg (95% CI: 0.88-6.98, P = 0.02) if a patient was African American or 3.7 mg (95% CI: 0.53-6.89, P = 0.03) if the total daily ritonavir dose was 200 mg. The required WMD was significantly higher in patients receiving ART. Prompt dose titration to achieve a higher WMD with vigilant monitoring may be required due to these drug-drug interactions.

  10. “Fake product? Why not!” Attitudes toward the consumption of counterfeit goods in CEE as shown on the example of Slovakia

    Directory of Open Access Journals (Sweden)

    Denisa Kasl Kollmannová

    2012-09-01

    Full Text Available This article focuses on the increasing consumption trend of counterfeit goods in the countries of CEE and on the consequences for the global market. Counterfeiting is not longer typical only for the luxury market, where branding together with genuine source plays a crucial role and the business of top luxury is rising during the crisis. New categories of counterfeit goods are emerging constantly, including electronics and computer parts, pharmaceuticals, even FMCG such as food, beverages or cosmetics. This article presents data from GfK research on attitudes towards counterfeit goods in Slovakia and puts it to the context of other CEE countries. It gives clear managerial implications on how to communicate the importance of originality, benefits for the consumer when consuming original goods and social marketing of ethical consumption.

  11. Antiretroviral drug supply challenges in the era of scaling up ART in Malawi.

    Science.gov (United States)

    Schouten, Erik J; Jahn, Andreas; Ben-Smith, Anne; Makombe, Simon D; Harries, Anthony D; Aboagye-Nyame, Francis; Chimbwandira, Frank

    2011-07-06

    The number of people receiving antiretroviral treatment (ART) has increased considerably in recent years and is expected to continue to grow in the coming years. A major challenge is to maintain uninterrupted supplies of antiretroviral (ARV) drugs and prevent stock outs. This article discusses issues around the management of ARVs and prevention of stock outs in Malawi, a low-income country with a high HIV/AIDS burden, and a weak procurement and supply chain management system. This system for ARVs, paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, and bypassing the government Central Medical Stores, is in place, using the United Nations Children's Fund's (UNICEF's) procurement services. The system, managed by a handful of people who spend limited time on supply management, is characterized by a centrally coordinated quantification based on verified data from all national ART clinics, parallel procurement through UNICEF, and direct distribution to ART clinics. The model worked well in the first years of the ART programme with a single first-line ARV regimen, but with more regimens becoming available (e.g., alternative first-line, second-line and paediatric regimens), it has become more difficult to administer. Managing supplies through a parallel system has the advantage that weaknesses in the national system have limited influence on the ARV procurement and supply chain management system. However, as the current system operates without a central warehouse and national buffer stock capacity, it diminishes the ability to prevent ARV stock outs. The process of ordering ARVs, from the time that estimates are made to the arrival of supplies in health facilities, takes approximately one year. Addressing the challenges involved in maintaining ARVs through an efficient procurement and supply chain management system that prevents ARV stock outs through the establishment of a dedicated procurement team, a central warehouse and/or national buffer stock is a

  12. Global trends in antiretroviral resistance in treatment-naive individuals with HIV after rollout of antiretroviral treatment in resource-limited settings: a global collaborative study and meta-regression analysis

    NARCIS (Netherlands)

    Gupta, Ravindra K.; Jordan, Michael R.; Sultan, Binta J.; Hill, Andrew; Davis, Daniel H. J.; Gregson, John; Sawyer, Anthony W.; Hamers, Raph L.; Ndembi, Nicaise; Pillay, Deenan; Bertagnolio, Silvia

    2012-01-01

    Background The emergence and spread of high levels of HIV-1 drug resistance in resource-limited settings where combination antiretroviral treatment has been scaled up could compromise the effectiveness of national HIV treatment programmes. We aimed to estimate changes in the prevalence of HIV-1 drug

  13. Effects of antiretroviral drug recall on perception of therapy benefits and on adherence to antiretroviral treatment in HIV-infected children.

    Science.gov (United States)

    Giannattasio, Antonietta; Barbarino, Alessandro; Lo Vecchio, Andrea; Bruzzese, Eugenia; Mango, Carmela; Guarino, Alfredo

    2009-09-01

    In June 2007, the European Medicines Agency announced the recall by Roche of nelfinavir from European Union markets because of contamination of tablets with ethyl mesylate. Based on this event, we investigated the effect of switching therapy because of nelfinavir recall or for other reasons on the perception of therapy benefits and adherence to treatment in HIV-infected children and their caregivers. Thirty-eight children (mean age 12.1+/-6.7 years) were enrolled. A 35-item questionnaire was administered to the caregivers of enrolled children. Adherence was evaluated through a 4-day recall adherence instrument. Enrolled children were divided into 3 groups: patients who were shifted because of nelfinavir recall (group A, 8 patients); patients who were shifted for other reasons (group B, 12 patients); patients who were not shifted in the last 6 months (group C, 18 patients). All caregivers considered antiretroviral therapy necessary and effective for their children. However, drug shifting generated anxiety in most of them, irrespective of the reason for shifting. At baseline, 74% patients adhered to therapy. Adherence rate was related to the type of caregivers being higher in children cared for by foster parents than in children cared for by biological parents or second-degree relatives. Adherence rates did not change significantly in groups A and B after switching. Drug-switching raises concern in caregivers of HIV-infected children and induces a negative feeling irrespective of the reason for switching. However, switching, including the shift due to nelfinavir recall, did not affect adherence rates.

  14. Efeito das drogas anti-retrovirais sobre as taxas de fertilidade de ratas Wistar Effects of antiretroviral drugs on fertility of Wistar rats

    Directory of Open Access Journals (Sweden)

    Ernesto Antonio Figueiró Filho

    2002-12-01

    írus da imunodeficiência humana.PURPOSE: to evaluate experimentally the effects of antiretroviral drugs used alone and in association upon the fertility of pregnant Wistar rats and the perinatal effects on the offspring. METHODS: adult female pregnant Wistar rats weighing 200-230 g were used. The antiretroviral drugs zidovudine (AZT, lamivudine (3TC and nelfinavir (NFV were used alone and in association at daily doses of ten times the dose normally used in pregnant women, proportionally to the animal's body weight. Seven groups were studied, including the control one. The experiment started on day 0 and the pregnant animals were sacrificed on day 21. The alive and dead fetuses, the total implantation sites and the total numbers of corporea lutea were used to calculate the fertility values. The statistical analysis was performed by Student's t test and by the Mann-Whitney test. RESULTS: there were no significant statistical differences regarding preimplantation loss and implantation efficiency values of the rats treated with isolated and associated antiretroviral drugs. There was a significant increase in the postimplantation loss values (control group: 7.6%; drug groups variation: 20.2-26.7%, a decrease in the fetal viability values (control group: 92.4%, drug groups variation: 73.3-79.8%, and a decreasing number of fetuses per animal (control group: 14.7; drug groups variation: 11.1-12.7. There was a significant weight reduction of the female rats and of the offspring of animals treated with 3TC, AZT + 3TC and AZT + 3TC + NFV. CONCLUSION: with the administration of high antiretroviral doses, important fertility effects could be observed, which showed that less histotoxic antiretroviral drugs must be studied in order to warrant the safety of using these medicines in pregnant HIV-1 - infected women.

  15. HIV-1 drug resistance before initiation or re-initiation of first-line antiretroviral therapy in low-income and middle-income countries: a systematic review and meta-regression analysis

    NARCIS (Netherlands)

    Gupta, Ravindra K.; Gregson, John; Parkin, Neil; Haile-Selassie, Hiwot; Tanuri, Amilcar; Andrade Forero, Liliana; Kaleebu, Pontiano; Watera, Christine; Aghokeng, Avelin; Mutenda, Nicholus; Dzangare, Janet; Hone, San; Hang, Zaw Zaw; Garcia, Judith; Garcia, Zully; Marchorro, Paola; Beteta, Enrique; Giron, Amalia; Hamers, Raph; Inzaule, Seth; Frenkel, Lisa M.; Chung, Michael H.; de Oliveira, Tulio; Pillay, Deenan; Naidoo, Kogie; Kharsany, Ayesha; Kugathasan, Ruthiran; Cutino, Teresa; Hunt, Gillian; Avila Rios, Santiago; Doherty, Meg; Jordan, Michael R.; Bertagnolio, Silvia

    2018-01-01

    Pretreatment drug resistance in people initiating or re-initiating antiretroviral therapy (ART) containing non-nucleoside reverse transcriptase inhibitors (NNRTIs) might compromise HIV control in low-income and middle-income countries (LMICs). We aimed to assess the scale of this problem and whether

  16. Limited indications of tax stamp discordance and counterfeiting on cigarette packs purchased in tobacco retailers, 97 counties, USA, 2012.

    Science.gov (United States)

    Lee, Joseph G L; Golden, Shelley D; Ribisl, Kurt M

    2017-12-01

    Increasing the per-unit cost of tobacco products is one of the strongest interventions for tobacco control. In jurisdictions with higher taxes in the U.S., however, cigarette pack litter studies show a substantial proportion of littered packs lack the appropriate tax stamp. More limited but still present counterfeiting also exists. We sought to examine the role of tobacco retailers as a source for untaxed and counterfeit products. Data collectors purchased Newport Green (menthol) or Marlboro Red cigarette packs in a national probability-based sample of tobacco retailers (in 97 counties) from June-October 2012. They made no effort to buy counterfeit or untaxed cigarettes. In this cross-sectional study, we assessed the presence, tax authority, and type (low-tech thermal vs. encrypted) of cigarette pack tax stamps; concordance of tax stamps with where the pack was purchased; and, for Marlboro cigarettes, publicly available visible indicators of counterfeiting. We purchased 2147 packs of which 2033 had tax stamps. Packs missing stamps were in states that do not require them. We found very limited discordance between store location and tax stamp(s) (tax stamps (13%). This occurred entirely with low-tech tax stamps and was not identified with encrypted tax stamps. We found no clear evidence of counterfeit products. Almost all tax stamps matched the location of purchase. Litter studies may be picking up legal tax avoidance instead of illegal tax evasion or, alternatively, purchase of illicit products requires special request by the purchaser.

  17. Antiretroviral Tissue Kinetics: In Vivo Imaging Using Positron Emission Tomography▿

    OpenAIRE

    Di Mascio, Michele; Srinivasula, Sharat; Bhattacharjee, Abesh; Cheng, Lily; Martiniova, Lucia; Herscovitch, Peter; Lertora, Juan; Kiesewetter, Dale

    2009-01-01

    Our current knowledge on the antiviral efficacy, dosing, and toxicity of available highly active antiretroviral therapy regimens is mostly derived from plasma or blood kinetics of anti-human immunodeficiency virus (anti-HIV) drugs. However, the blood comprises only 2% of the total target cells in the body. Tissue drug levels may differ substantially from corresponding plasma levels, and drug distribution processes may be characterized by high intertissue variability, leading to suboptimal tar...

  18. Untangling the cost-effectiveness knot: who is oral antiretroviral HIV pre-exposure prophylaxis really for?

    NARCIS (Netherlands)

    Hankins, Catherine A.

    2014-01-01

    Clinical trials of HIV pre-exposure prophylaxis (PrEP) antiretroviral drugs have shown excellent protection against HIV acquisition when plasma drug levels are detectable, indicating good adherence. Cost-effectiveness depends on epidemic context, adherence, drug cost, and other factors. For

  19. WGOE Discussion topic introduction: Counterfeit, Suspect, and Fraudulent parts

    International Nuclear Information System (INIS)

    Thorp, John

    2011-01-01

    This presentation (slides) provided an introduction to CSFI discussion. It presents: 1 - the many faces of counterfeiting (design and intellectual property, manufacturing and fabrication, product control, branding and document fraud), 2 - the key messages from the June 3, 2010 US-NRC Commission Briefing, 3 - the Regulator's role in ensuring nuclear plant safety, 4 - the CSFI survey status, 5 - the questions to be discussed during the meeting

  20. Perceived Quality Of Counterfeit Perfume And Original Perfume

    OpenAIRE

    Saerang, David Paul Elia; Turk, Caleb Elijah

    2015-01-01

    Perfume is one type of product that often has prestigious prices tied with quality to attract consumers, which (as often is seen with high-priced products) arouses the interests of counterfeiters to copy the originals. Perfume comes in many fragrances which are offered to customers. Fragrances have their own characteristics in order to match with the various tastes, moods, and occasions they may want them for. Perfume also can reflect certain life-styles. Perfume creates different perceived v...

  1. [Predictive factors of clinically significant drug-drug interactions among regimens based on protease inhibitors, non-nucleoside reverse transcriptase inhibitors and raltegravir].

    Science.gov (United States)

    Cervero, Miguel; Torres, Rafael; Jusdado, Juan José; Pastor, Susana; Agud, Jose Luis

    2016-04-15

    To determine the prevalence and types of clinically significant drug-drug interactions (CSDI) in the drug regimens of HIV-infected patients receiving antiretroviral treatment. retrospective review of database. Centre: Hospital Universitario Severo Ochoa, Infectious Unit. one hundred and forty-two participants followed by one of the authors were selected from January 1985 to December 2014. from their outpatient medical records we reviewed information from the last available visit of the participants, in relation to HIV infection, comorbidities, demographics and the drugs that they were receiving; both antiretroviral drugs and drugs not related to HIV infection. We defined CSDI from the information sheet and/or database on antiretroviral drug interactions of the University of Liverpool (http://www.hiv-druginteractions.org) and we developed a diagnostic tool to predict the possibility of CSDI. By multivariate logistic regression analysis and by estimating the diagnostic performance curve obtained, we identified a quick tool to predict the existence of drug interactions. Of 142 patients, 39 (29.11%) had some type of CSDI and in 11.2% 2 or more interactions were detected. In only one patient the combination of drugs was contraindicated (this patient was receiving darunavir/r and quetiapine). In multivariate analyses, predictors of CSDI were regimen type (PI or NNRTI) and the use of 3 or more non-antiretroviral drugs (AUC 0.886, 95% CI 0.828 to 0.944; P=.0001). The risk was 18.55 times in those receiving NNRTI and 27,95 times in those receiving IP compared to those taking raltegravir. Drug interactions, including those defined as clinically significant, are common in HIV-infected patients treated with antiretroviral drugs, and the risk is greater in IP-based regimens. Raltegravir-based prescribing, especially in patients who receive at least 3 non-HIV drugs could avoid interactions. Copyright © 2016 Elsevier España, S.L.U. All rights reserved.

  2. Inorganic Profiling of Amoxicillin Drugs in Ghana Using Proton Induced X-Ray Emission (Pixe) Analysis

    International Nuclear Information System (INIS)

    Abdul-Wahab, Zurika

    2017-07-01

    The increase of drug counterfeits and its unconscious use has become a major cause for concern to health care practitioners and relevant stakeholders. The occurrence of counterfeit or fake drugs is perceived to be a problem encountered in both developing and underdeveloped nations where Ghana is not an exemption. The lethal implications of counterfeit/fake medications are well understood to be a major challenge to the soundness of public health systems around the world, as well as a direct threat to our individual health and well-being. Sub-standard and counterfeit/fake drugs are a widespread problem in Ghana and the need to address it is eminent. The volume of drugs that require control, from the statutory organisations like Food and Drugs Authority of Ghana (FDA) and Ghana Standard Authority (GSA) is enormous, and hence the need to explore other faster analytical techniques to help control cannot be over emphasised. According to the World Health Organization (WHO), Antibiotics are the most counterfeited drugs and Amoxicillin (C 16 H 19 N 3 O 5 S) happened to be ranked first on the list. The most used and prescribed method for drug quality control analysis is the High-Performance Liquid Chromatography (HPLC) technique which accesses the quality of drugs from its Active Principal Ingredient (API) perspective. The main focus of this study is to harness additional analytical procedure to enhance the routine monitoring of the quality of some Amoxicillin drugs in Ghana from the inorganic constituent point of view. HPLC and the physical parameter tests were carried out on the samples analysed to help validate the interpretation of the inorganic element results from the PIXE technique. Two different local brands of amoxicillin and two imported amoxicillin brands were chosen for this study. A total of 30 samples were analysed for this study including one (1) standard reference material (amoxicillin) acquired from a licenced pharmaceutical company in Ghana. Particle

  3. Quality of life of people living with HIV and AIDS and antiretroviral therapy

    OpenAIRE

    Oguntibeju, Oluwafemi

    2012-01-01

    Oluwafemi O OguntibejuOxidative Stress Research Centre, Cape Peninsula University of Technology, Bellville, South AfricaAbstract: The development of antiretroviral drugs has significantly changed the perception of HIV/AIDS from a very fatal to a chronic and potentially manageable disease, and the availability and administration of antiretroviral therapy (ART) has significantly reduced mortality and morbidity associated with HIV and AIDS. There is a relationship between ART and quality of life...

  4. Counterfeit, Suspect, Fraudulent Items (CSFI): Today and Tomorrow

    International Nuclear Information System (INIS)

    Pasquale, Daniel

    2011-01-01

    This presentation (slides) addresses the U.S. NRC's current perception of the CSFI threat as it relates to existing licensed operating nuclear power plants as well as future units. The presentation addressed the following topics: 1) recent CSFI activity, 2) the role of Quality Assurance, 3) what the US NRC is doing, 4) US NRC outreach efforts, and 5) the need for a solid CSFI community. The presentation refers to the growing CSFI threat to other heavy industries as reported recently by the U.S. Department of Commerce, and describes how the existing US NRC guidance on this issue has proven to be the foundation for a strong anti-counterfeiting program. It also stresses the need for all stakeholders to adopt and maintain a proactive approach to counter the CSFI threat, including the need to share information, institute a zero tolerance policy, involve engineering in the procurement and product inspection processes, ensure that inspection processes (source, receipt, and testing) are effective, and to utilize engineering based programs in support of commercial grade dedication activities. Included with the presentation is a comprehensive list of generic communications issued by the U.S. NRC in response to counterfeit/fraudulent items over the years, and some of the various electronic repositories regarding the nuclear industry where related event information may be accessed

  5. Through-container, extremely low concentration detection of multiple chemical markers of counterfeit alcohol using a handheld SORS device

    OpenAIRE

    Ellis, David; R, Eccles; Xu, Yun; J, Griffen; Muhamadali, H; P, Matousek; Goodall, I; Goodacre, Royston

    2017-01-01

    Major food adulteration incidents occur with alarming frequency and are episodic, with the latest incident, involving the adulteration of meat from 21 producers in Brazil supplied to 60 other countries, reinforcing this view. Food fraud and counterfeiting involves all types of foods, feed, beverages, and packaging, with the potential for serious health, as well as significant economic and social impacts. In the spirit drinks sector, counterfeiters often ‘recycle’ used genuine packaging, or em...

  6. Integrated circuit authentication hardware Trojans and counterfeit detection

    CERN Document Server

    Tehranipoor, Mohammad; Zhang, Xuehui

    2013-01-01

    This book describes techniques to verify the authenticity of integrated circuits (ICs). It focuses on hardware Trojan detection and prevention and counterfeit detection and prevention. The authors discuss a variety of detection schemes and design methodologies for improving Trojan detection techniques, as well as various attempts at developing hardware Trojans in IP cores and ICs. While describing existing Trojan detection methods, the authors also analyze their effectiveness in disclosing various types of Trojans, and demonstrate several architecture-level solutions. 

  7. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

    Science.gov (United States)

    Nunn, Amy S; Fonseca, Elize M; Bastos, Francisco I; Gruskin, Sofia; Salomon, Joshua A

    2007-11-13

    Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART) for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs), procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005. We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r) have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs: patented lopinavir

  8. Evolution of antiretroviral drug costs in Brazil in the context of free and universal access to AIDS treatment.

    Directory of Open Access Journals (Sweden)

    Amy S Nunn

    2007-11-01

    Full Text Available Little is known about the long-term drug costs associated with treating AIDS in developing countries. Brazil's AIDS treatment program has been cited widely as the developing world's largest and most successful AIDS treatment program. The program guarantees free access to highly active antiretroviral therapy (HAART for all people living with HIV/AIDS in need of treatment. Brazil produces non-patented generic antiretroviral drugs (ARVs, procures many patented ARVs with negotiated price reductions, and recently issued a compulsory license to import one patented ARV. In this study, we investigate the drivers of recent ARV cost trends in Brazil through analysis of drug-specific prices and expenditures between 2001 and 2005.We compared Brazil's ARV prices to those in other low- and middle-income countries. We analyzed trends in drug expenditures for HAART in Brazil from 2001 to 2005 on the basis of cost data disaggregated by each ARV purchased by the Brazilian program. We decomposed the overall changes in expenditures to compare the relative impacts of changes in drug prices and drug purchase quantities. We also estimated the excess costs attributable to the difference between prices for generics in Brazil and the lowest global prices for these drugs. Finally, we estimated the savings attributable to Brazil's reduced prices for patented drugs. Negotiated drug prices in Brazil are lowest for patented ARVs for which generic competition is emerging. In recent years, the prices for efavirenz and lopinavir-ritonavir (lopinavir/r have been lower in Brazil than in other middle-income countries. In contrast, the price of tenofovir is US$200 higher per patient per year than that reported in other middle-income countries. Despite precipitous price declines for four patented ARVs, total Brazilian drug expenditures doubled, to reach US$414 million in 2005. We find that the major driver of cost increases was increased purchase quantities of six specific drugs

  9. The National Access to Antiretroviral Program for PHA (NAPHA) in Thailand.

    Science.gov (United States)

    Chasombat, Sanchai; Lertpiriyasuwat, Cheewanan; Thanprasertsuk, Sombat; Suebsaeng, Laksami; Lo, Ying Ru

    2006-07-01

    To describe the development, components, initial results and lessons learned from Thailand's National Access to Antiretroviral Program for People living with HIV/AIDS (NAPHA), a historical review was conducted and program monitoring was analyzed. The national antiretroviral therapy program at different levels of the public health system was implemented with all major program components; ARV protocol development, health care professional training, drug supply chain management, laboratory network formation, monitoring and evaluation, and multi-sector and PHA involvement since 2001, which was based on elements of research, pilot projects, training, national guideline development, experiences and policy making. A national monitoring system was developed to monitor the progress of the program. From February 2001 to December 2004, the monitoring reports received from implementing hospitals showed that 58,133 cases had received antiretroviral therapy (ART), and 85% (49,477) of them were continuing to take ARV drugs. In conclusion, the NAPHA was implemented nationwide with comprehensive systems. The reports indicate achievement of expansion of the ART program. Lessons learned from the program initiation and scaling up show local leadership, comprehensive training, adherence, and coordination are essential to program effectiveness and sustainability.

  10. Magnetic resonance imaging of folic acid-coated magnetite nanoparticles reflects tissue biodistribution of long-acting antiretroviral therapy.

    Science.gov (United States)

    Li, Tianyuzi; Gendelman, Howard E; Zhang, Gang; Puligujja, Pavan; McMillan, JoEllyn M; Bronich, Tatiana K; Edagwa, Benson; Liu, Xin-Ming; Boska, Michael D

    2015-01-01

    Regimen adherence, systemic toxicities, and limited drug penetrance to viral reservoirs are obstacles limiting the effectiveness of antiretroviral therapy (ART). Our laboratory's development of the monocyte-macrophage-targeted long-acting nanoformulated ART (nanoART) carriage provides a novel opportunity to simplify drug-dosing regimens. Progress has nonetheless been slowed by cumbersome, but required, pharmacokinetic (PK), pharmacodynamics, and biodistribution testing. To this end, we developed a small magnetite ART (SMART) nanoparticle platform to assess antiretroviral drug tissue biodistribution and PK using magnetic resonance imaging (MRI) scans. Herein, we have taken this technique a significant step further by determining nanoART PK with folic acid (FA) decorated magnetite (ultrasmall superparamagnetic iron oxide [USPIO]) particles and by using SMART particles. FA nanoparticles enhanced the entry and particle retention to the reticuloendothelial system over nondecorated polymers after systemic administration into mice. These data were seen by MRI testing and validated by comparison with SMART particles and direct evaluation of tissue drug levels after nanoART. The development of alendronate (ALN)-coated magnetite thus serves as a rapid initial screen for the ability of targeting ligands to enhance nanoparticle-antiretroviral drug biodistribution, underscoring the value of decorated magnetite particles as a theranostic tool for improved drug delivery.

  11. HIV-1 drug resistance surveillance in antiretroviral treatment-naive individuals from a reference hospital in Guatemala, 2010-2013.

    Science.gov (United States)

    Avila-Ríos, Santiago; García-Morales, Claudia; Garrido-Rodríguez, Daniela; Tapia-Trejo, Daniela; Girón-Callejas, Amalia Carolina; Mendizábal-Burastero, Ricardo; Escobar-Urias, Ingrid Yessenia; García-González, Blanca Leticia; Navas-Castillo, Sabrina; Pinzón-Meza, Rodolfo; Mejía-Villatoro, Carlos Rodolfo; Reyes-Terán, Gustavo

    2015-04-01

    The recent expansion of antiretroviral treatment (ART) coverage in middle/low-income countries has been associated with increasing prevalence of HIV pre-ART drug resistance (PDR). We assessed PDR prevalence, patterns, and trends in Guatemala. Blood samples from 1,084 ART-naive individuals, enrolled from October 2010 to December 2013 at the Roosevelt Hospital in Guatemala City, were obtained. PDR was evaluated using the WHO mutation list for transmitted drug resistance (TDR) surveillance. An overall PDR prevalence of 7.3% (95% CI 5.8-9.0%) was observed for the whole study period. TDR to nonnucleoside reverse transcriptase inhibitors (NNRTI) was the highest (4.9%, p500 and 350-500 CD4(+) T cells/μl (7.4% and 8.7%, respectively) compared to individuals with Guatemala remains at an intermediate level. Nevertheless, we have shown evidence suggesting increasing trends in NNRTI PDR, which need to be taken into account in national HIV management policies.

  12. HIV-1 anti-retroviral drug effect on the C. albicans hyphal growth rate by a Bio-Cell Tracer system Efeito da droga anti-retroviral HIV-1 no crescimento de hifas de C. albicans monitoradas pelo sistema "Bio-Cell Tracer"

    Directory of Open Access Journals (Sweden)

    Nadja Rodrigues de Melo

    2006-09-01

    Full Text Available Declining incidence of oropharyngeal candidosis and opportunistic infections over recent years can be attributed to the use of highly active anti-retroviral therapy (HAART. Infection with C. albicans generally involves adherence and colonization of superficial tissues. During this process, budding yeasts are able to transform to hyphae and penetrate into the deep tissue. Using the biocell tracer system, C. albicans hyphal growth was dynamically observed at the cellular level. Ritonavir was effective in the inhibition of hyphal growth with growth rate of 0.8 mum/min. This study showed the in vitro effect of HIV anti-retroviral drug on the growth rate of the C. albicans hyphae.O declínio na incidência de candidose orofaríngea e infecções oportunistas associadas a infecção pelo HIV tem sido atribuído a introdução da terapia antiretroviral combinada (HAART. Infecção por C. albicans envolve aderência e colonização da mucosa superficial. Durante este processo leveduras são capazes de transformar-se na forma de hifas e penetrar nos tecidos mais profundos. Usando o sistema "Bio-Cell Tracer", o crescimento de hifas de C. albicans foi observado dinamicamente a nível celular. Ritonavir, inibidor de protease do HIV, foi efetivo na inibição do crescimento de hifas com media de 0.8 mim/min.O presente estudo demonstrou o efeito in vitro de um agente anti-retroviral HIV sobre o crescimento de hifas de C. albicans.

  13. Correlates of HIV-1 viral suppression in a cohort of HIV-positive drug users receiving antiretroviral therapy in Hanoi, Vietnam

    Science.gov (United States)

    Jordan, Michael R; La, Hanh; Nguyen, Hien Duc; Sheehan, Heidi; Lien, Trinh Thi Minh; Van Dang, Duong; Hellinger, James; Wanke, Christine; Tang, Alice M

    2009-01-01

    Summary Injection drug users bear the burden of HIV in Vietnam and are a focus of national treatment programs. To date, determinants of successful therapy in this population are unknown. Substance use and clinical correlates of viral suppression were studied in 100 HIV-1 infected drug users receiving antiretroviral therapy (ART) for at least 6 months in Hanoi, Vietnam. Mean age of the cohort was 29.9 + 4.9 years; all were men. A majority of patients (73%) achieved viral suppression (HIV-RNA 95% adherence (p<0.01) and current use of trimethoprim/sulfamethoxazole (p<0.01); current or ever diagnosed with tuberculosis was associated with viral non-suppression (p=0.006). Tobacco use was prevalent (84%), and surprisingly 48% of patients reported active drug use; neither was associated with viral non-suppression. This is the first study to document successful ART treatment in a population of Vietnamese drug users; rates of viral suppression are comparable to other international populations. The 28% of patients without HIV-1 suppression highlights the need for adherence promotion, risk reduction programs, and population based surveillance strategies for assessing the emergence of HIV drug resistance in settings where access to viral load and drug resistance testing is limited. PMID:19451329

  14. Social power, product conspicuousness, and the demand for luxury brand counterfeit products.

    Science.gov (United States)

    Bian, Xuemei; Haque, Sadia; Smith, Andrew

    2015-03-01

    The aim of this article is twofold: (1) to achieve a better understanding of the psychological determinants of the demand for luxury brand counterfeit products (LBCP) through exploring the effects of social power; (2) to extend power literature by identifying boundary conditions of the relationship between social power and compensatory consumption identified by Rucker and Galinsky (2008, J. Consum. Res., 35, 257-267) and Rucker and Galinsky (2009, J. Exp. Soc. Psychol., 45, 549-555). Findings from three experiments demonstrate that social power holds key insights into understanding consumers' purchase propensity for LBCP; product conspicuousness moderates the effects of social power on purchase propensity for status products; these moderation effects are only observed when the status products are LBCP but not genuine products. This article, therefore, contributes to the literature regarding the demand for counterfeits as well as the social power and compensatory consumption literature. © 2014 The British Psychological Society.

  15. Accessibility of antiretroviral therapy in Ghana: Convenience of access

    African Journals Online (AJOL)

    Joyce Addo-Atuah * Joyce Addo-Atuah, BPharm, MSc, PhD, Assistant Professor, Touro College of Pharmacy, New York, USA. She was a PhD candidate at the University of Tennessee (UT), Memphis, USA, when the study was undertaken in Ghana. joyce.addo-atuah@touro.edu, Dick Gourley Dick Gourley, PharmD, Professor and Dean, UT College of Pharmacy during the study and major research advisor. , Greta Gourley Greta Gourley, PharmD/PhD, retired Associate Professor of Pharmaceutical Sciences at UT College of Pharmacy and research advisor. , Shelley I. White-Means Shelley I. White-Means, PhD, Professor and Chair, Health Outcomes and Policy Research Division of UT College of Pharmacy at time of the study and research advisor. , Robin J. Womeodu Robin J. Womeodu, MD, F.A.C.P., Associate Professor of Internal Medicine and Preventive Medicine at UT College of Medicine at time of study and research advisor. , Richard J. Faris Richard J. Faris, Assistant Professor at UT College of Pharmacy at time of study and research advisor. &

    2012-05-30

    May 30, 2012 ... The accuracy of any instructions, formulae, and drug doses ... The convenience of accessing antiretroviral therapy (ART) is ...... tious diseases, paediatrics, chest diseases, dermatology, public .... CD4 count, (2) a full blood count, (3) a liver function test, (4) ..... America: measures of the African brain drain.

  16. Addressing Counterfeit Parts in the DoD Supply Chain

    Science.gov (United States)

    2014-03-01

    property rights to that part. Franchised distributor Distributor with which OCM has a contractual agreement to buy , stock, repackage, sell, and...because the DoD is not the largest buyer of microelectronics, the private sector market must buy into DNA tagging in order for manufacturers to include...tacitly acknowledged that “it is impossible to eliminate all risk of counterfeit in every system that the DoD buys or supports” (p. 3). Thus, Metzger

  17. Fate of the antiretroviral drug tenofovir in agricultural soil

    Energy Technology Data Exchange (ETDEWEB)

    Al-Rajab, Abdul Jabbar; Sabourin, Lyne; Chapman, Ralph; Lapen, David R.; Topp, Edward, E-mail: ed.topp@agr.gc.ca [Agriculture and Agri-Food Canada, London, ON, N5V 4T3 (Canada)

    2010-10-15

    Tenofovir (9-(R)-(2-phosphonylmethoxypropyl)-adenine) is an antiretroviral drug widely used for the treatment of human immunodeficiency virus (HIV-1) and Hepatitis B virus (HBV) infections. Tenofovir is extensively and rapidly excreted unchanged in the urine. In the expectation that tenofovir could potentially reach agricultural lands through the application of municipal biosolids or wastewater, and in the absence of any environmental fate data, we evaluated its persistence in selected agricultural soils. Less than 10% of [adenine-8-{sup 14}C]-tenofovir added to soils varying widely in texture (sand, loam, clay loam) was mineralized in a 2-month incubation under laboratory conditions. Tenofovir was less readily extractable from clay soils than from a loam or a sandy loam soil. Radioactive residues of tenofovir were removed from the soil extractable fraction with DT{sub 50}s ranging from 24 {+-} 2 to 67 + 22 days (first order kinetic model) or 44 + 9 to 127 + 55 days (zero order model). No extractable transformation products were detectable by HPLC. Tenofovir mineralization in the loam soil increased with temperature (range 4 {sup o}C to 30 {sup o}C), and did not occur in autoclaved soil, suggesting a microbial basis. Mineralization rates increased with soil moisture content, ranging from air-dried to saturated. In summary, tenofovir was relatively persistent in soils, there were no extractable transformation products detected, and the response of [adenine-8-{sup 14}C]-tenofovir mineralization to soil temperature and heat sterilization indicated that the molecule was biodegraded by aerobic microorganisms. Sorption isotherms with dewatered biosolids suggested that tenofovir residues could potentially partition into the particulate fraction during sewage treatment.

  18. Limited indications of tax stamp discordance and counterfeiting on cigarette packs purchased in tobacco retailers, 97 counties, USA, 2012

    Directory of Open Access Journals (Sweden)

    Joseph G.L. Lee

    2017-12-01

    Full Text Available Increasing the per-unit cost of tobacco products is one of the strongest interventions for tobacco control. In jurisdictions with higher taxes in the U.S., however, cigarette pack litter studies show a substantial proportion of littered packs lack the appropriate tax stamp. More limited but still present counterfeiting also exists. We sought to examine the role of tobacco retailers as a source for untaxed and counterfeit products. Data collectors purchased Newport Green (menthol or Marlboro Red cigarette packs in a national probability-based sample of tobacco retailers (in 97 counties from June–October 2012. They made no effort to buy counterfeit or untaxed cigarettes. In this cross-sectional study, we assessed the presence, tax authority, and type (low-tech thermal vs. encrypted of cigarette pack tax stamps; concordance of tax stamps with where the pack was purchased; and, for Marlboro cigarettes, publicly available visible indicators of counterfeiting. We purchased 2147 packs of which 2033 had tax stamps. Packs missing stamps were in states that do not require them. We found very limited discordance between store location and tax stamp(s (<1%. However, a substantial minority of cigarette packs had damaged tax stamps (13%. This occurred entirely with low-tech tax stamps and was not identified with encrypted tax stamps. We found no clear evidence of counterfeit products. Almost all tax stamps matched the location of purchase. Litter studies may be picking up legal tax avoidance instead of illegal tax evasion or, alternatively, purchase of illicit products requires special request by the purchaser. Keywords: Taxes, Smoking, Tobacco products, Government regulation, Government

  19. Platelet count kinetics following interruption of antiretroviral treatment.

    Science.gov (United States)

    Zetterberg, Eva; Neuhaus, Jacqueline; Baker, Jason V; Somboonwit, Charurut; Llibre, Josep M; Palfreeman, Adrian; Chini, Maria; Lundgren, Jens D

    2013-01-02

    To investigate the mechanisms of platelet kinetics in the Strategies for Management of Antiretroviral Therapy (SMART) study that demonstrated excess mortality with CD4 guided episodic antiretroviral therapy (ART) drug conservation compared with continuous treatment viral suppression. Follow-up analyses of stored plasma samples demonstrated increased activation of both inflammatory and coagulation pathways after stopping ART. SMART patients from sites that determined platelets routinely. Platelet counts were retrospectively collected from 2206 patients from visits at study entry, and during follow-up. D-dimer levels were measured at study entry, month 1, and 2. Platelet levels decreased in the drug conservation group following randomization, but remained stable in the viral suppression group [median (IQR) decline from study entry to month 4: -24 000/μl (-54 000 to 4000) vs. 3000 (-22 000 to 24 000), respectively, P conservation vs. the viral suppression arm (unadjusted drug conservation/viral suppression [HR (95%CI) = 1.8 (1.2-2.7)]. The decline in platelet count among drug conservation participants on fully suppressive ART correlated with the rise in D-dimer from study entry to either month 1 or 2 (r = -0.41; P = 0.02). Among drug conservation participants who resumed ART 74% recovered to their study entry platelet levels. Interrupting ART increases the risk of thrombocytopenia, but reinitiation of ART typically reverses it. Factors contributing to declines in platelets after interrupting ART may include activation of coagulation pathways or HIV-1 replication itself. The contribution of platelets in HIV-related procoagulant activity requires further study.

  20. 75 FR 79069 - Anti-Counterfeiting Trade Agreement: Request for Comments From the Public

    Science.gov (United States)

    2010-12-17

    ... proposed agreement to strengthen international cooperation, enforcement practices and legal frameworks for... international cooperation and to promote strong enforcement practices. Together these provisions will help to... OFFICE OF THE UNITED STATES TRADE REPRESENTATIVE Anti-Counterfeiting Trade Agreement: Request for...

  1. Enhanced antitumor efficacy and counterfeited cardiotoxicity of combinatorial oral therapy using Doxorubicin- and Coenzyme Q10-liquid crystalline nanoparticles in comparison with intravenous Adriamycin

    DEFF Research Database (Denmark)

    Swarnakar, Nitin K; Thanki, Kaushik; Jain, Sanyog

    2014-01-01

    and strong synergism for combination at 1:10 dose ratio owing to higher cellular uptake, nuclear colocalization, higher apoptotic index and 8-OHdG levels. The prophylactic antitumor efficacy of the CoQ10-LCNPs was also established using tumor induction and progression studies. Finally, therapeutic antitumor......, with Dox-induced-cardiotoxicity was completely counterfeited in combination. In nutshell, LCNPs pose great potential in improving the therapeutic efficacy of drugs by oral route of administration. FROM THE CLINICAL EDITOR: This study describes the use of liquid crystalline nanoparticles containing coenzyme...

  2. Relationship between self-reported adherence, antiretroviral drug concentration measurement and self-reported symptoms in patients treated for HIV-1 infection.

    Science.gov (United States)

    Fabbiani, Massimiliano; Di Giambenedetto, Simona; Cingolani, Antonella; Fanti, Iuri; Colafigli, Manuela; Tamburrini, Enrica; Cauda, Roberto; Navarra, Pierluigi; De Luca, Andrea; Murri, Rita

    2016-01-01

    The aim of the study was to explore relationships between self-reported adherence, antiretroviral drug concentration measurement (TDM) and self-reported symptoms. We systematically administered to human immunodeficiency (HIV)-infected outpatients a questionnaire evaluating measures of self-reported adherence (missing doses during last week, deviations from the prescribed timing of therapy, self-initiated discontinuations for > 24 or 48 h, exhausting drugs and present sense of how patients are taking therapy) and a panel of referred symptoms (a symptom score was built summing self-reported scores for each listed symptom). We selected patients who completed the questionnaire and also had a TDM (mainly reflecting adherence in the past few days or weeks), thus comparing these two tools as measures of adherence. A total of 130 patients (64.6% males, median age 44 years, 76.2% with HIV RNA HIV RNA symptom score was associated with a lower self-reported adherence and with a higher proportion of undetectable drug levels. Self-reported adherence and TDM showed a correlation and seemed to be comparable tools for adherence estimation. Self-reported symptoms were associated with lower adherence and undetectable drug levels.

  3. HIV-Antiretroviral Therapy Induced Liver, Gastrointestinal, and Pancreatic Injury

    Directory of Open Access Journals (Sweden)

    Manuela G. Neuman

    2012-01-01

    Full Text Available The present paper describes possible connections between antiretroviral therapies (ARTs used to treat human immunodeficiency virus (HIV infection and adverse drug reactions (ADRs encountered predominantly in the liver, including hypersensitivity syndrome reactions, as well as throughout the gastrointestinal system, including the pancreas. Highly active antiretroviral therapy (HAART has a positive influence on the quality of life and longevity in HIV patients, substantially reducing morbidity and mortality in this population. However, HAART produces a spectrum of ADRs. Alcohol consumption can interact with HAART as well as other pharmaceutical agents used for the prevention of opportunistic infections such as pneumonia and tuberculosis. Other coinfections that occur in HIV, such as hepatitis viruses B or C, cytomegalovirus, or herpes simplex virus, further complicate the etiology of HAART-induced ADRs. The aspect of liver pathology including liver structure and function has received little attention and deserves further evaluation. The materials used provide a data-supported approach. They are based on systematic review and analysis of recently published world literature (MedLine search and the experience of the authors in the specified topic. We conclude that therapeutic and drug monitoring of ART, using laboratory identification of phenotypic susceptibilities, drug interactions with other medications, drug interactions with herbal medicines, and alcohol intake might enable a safer use of this medication.

  4. Several criminal, phenomenological and etiological features of criminal offences of counterfeiting money in Kosovo

    Directory of Open Access Journals (Sweden)

    MSc. Milot Krasniqi

    2012-12-01

    Full Text Available The Republic of Kosovo is making efforts as a young state to strengthen rule of law and efficiently combat criminality in general, and specifically organized crime, as a condition for its journey towards European integration perspectives.  For a normal functioning of the economic system, the safety and protection of controlled circulation of money are of vital importance. In this direction, the state takes actions and measures to ensure that manufacturing and emissions of banknotes and bonds are undertaken by competent authorities, such as the Central Bank, and render impossible the counterfeiting of money. In Kosovo, money counterfeiting is not widely studied. Consequently, there are no recent research papers over the time when these offences have marked rather high records. This circumstance, and especially the fact that these offences are rather frequent in Kosovo, made me enter the research of this type of criminality.    Apart from principles and rules stipulated by special laws of the field of economy, protection of the economic system is also helped by the Criminal Code, which incriminates the act of counterfeit money as a criminal offence against the economic system, thereby ensuring general prevention of potential offenders, and repressive measures against confirmed offenders. Protection of economic and monetary systems is also provided upon by numerous international acts.  The paper is permeated by conclusions, analysis and independent recommendations, which I believe will contribute de lege ferrenda to criminal policies in preventing and combating this type of crime. In researching the criminal offences of counterfeiting money, I have used the method of historical materialism, dogmatic law method, statistical methods, surveys and interviews, and studies of individual cases.    From the research of this type of crime, I have concluded that these criminal offences are a serious type of crime, which may result in major individual

  5. Magnetic-graphitic-nanocapsule templated diacetylene assembly and photopolymerization for sensing and multicoded anti-counterfeiting

    Science.gov (United States)

    Nie, Xiang-Kun; Xu, Yi-Ting; Song, Zhi-Ling; Ding, Ding; Gao, Feng; Liang, Hao; Chen, Long; Bian, Xia; Chen, Zhuo; Tan, Weihong

    2014-10-01

    Molecular self-assembly, a process to design molecular entities to aggregate into desired structures, represents a promising bottom-up route towards precise construction of functional systems. Here we report a multifunctional, self-assembled system based on magnetic-graphitic-nanocapsule (MGN) templated diacetylene assembly and photopolymerization. The as-prepared assembly system maintains the unique color and fluorescence change properties of the polydiacetylene (PDA) polymers, while also pursues the superior Raman, NIR, magnetic and superconducting properties from the MGN template. Based on both fluorescence and magnetic resonance imaging (MRI) T2 relaxivity, the MGN@PDA system could efficiently monitor the pH variations which could be used as a pH sensor. The MGN@PDA system further demonstrates potential as unique ink for anti-counterfeiting applications. Reversible color change, strong and unique Raman scattering and fluorescence emission, sensitive NIR thermal response, and distinctive magnetic properties afford this assembly system with multicoded anti-counterfeiting capabilities.Molecular self-assembly, a process to design molecular entities to aggregate into desired structures, represents a promising bottom-up route towards precise construction of functional systems. Here we report a multifunctional, self-assembled system based on magnetic-graphitic-nanocapsule (MGN) templated diacetylene assembly and photopolymerization. The as-prepared assembly system maintains the unique color and fluorescence change properties of the polydiacetylene (PDA) polymers, while also pursues the superior Raman, NIR, magnetic and superconducting properties from the MGN template. Based on both fluorescence and magnetic resonance imaging (MRI) T2 relaxivity, the MGN@PDA system could efficiently monitor the pH variations which could be used as a pH sensor. The MGN@PDA system further demonstrates potential as unique ink for anti-counterfeiting applications. Reversible color change

  6. Invisible marking system by extreme ultraviolet radiation: the new frontier for anti-counterfeiting tags

    International Nuclear Information System (INIS)

    Lazzaro, P. Di; Bollanti, S.; Flora, F.; Mezi, L.; Murra, D.; Torre, A.; Bonfigli, F.; Montereali, R.M.; Vincenti, M.A.

    2016-01-01

    We present a marking technology which uses extreme ultraviolet radiation to write invisible patterns on tags based on alkali fluoride thin films. The shape of the pattern is pre-determined by a mask (in the case of contact lithography) or by a suitable mirror (projection lithography). Tags marked using this method offer a much better protection against fakes than currently available anti-counterfeiting techniques. The complexity and cost of this technology can be tailored to the value of the good to be protected, leaving, on the other hand, the specific reading technique straightforward. So far, we have exploited our invisible marking to tag artworks, identity cards, electrical components, and containers of radioactive wastes. Advantages and limits of this technology are discussed in comparison with the anti-counterfeiting systems available in the market.

  7. Antiretroviral Drug as a Cause of Bilateral Avascular Necrosis of the ...

    African Journals Online (AJOL)

    Background: Avascular necrosis (AVN) is one of the most dreadful disease conditions of the hip which may be very difficult to treat if not detected early. Protease inhibitor is useful in combined antiretroviral therapy but now being reported as one of the causes of AVN. In this case report, we present a case of bilateral ...

  8. Calculation of direct antiretroviral treatment costs and potential cost savings by using generics in the German HIV ClinSurv cohort.

    Directory of Open Access Journals (Sweden)

    Matthias Stoll

    Full Text Available UNLABELLED: BACKGROUND/AIM OF THE STUDY: The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART, -regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. METHODS: Antiretroviral regimens (ART from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. RESULTS: During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70. Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively. Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. CONCLUSIONS: Analysis of the data of this nationwide study reflects disease-specific health services research

  9. Calculation of direct antiretroviral treatment costs and potential cost savings by using generics in the German HIV ClinSurv cohort.

    Science.gov (United States)

    Stoll, Matthias; Kollan, Christian; Bergmann, Frank; Bogner, Johannes; Faetkenheuer, Gerd; Fritzsche, Carlos; Hoeper, Kirsten; Horst, Heinz-August; van Lunzen, Jan; Plettenberg, Andreas; Reuter, Stefan; Rockstroh, Jürgen; Stellbrink, Hans-Jürgen; Hamouda, Osamah; Bartmeyer, Barbara

    2011-01-01

    BACKGROUND/AIM OF THE STUDY: The study aimed to determine the cost impacts of antiretroviral drugs by analysing a long-term follow-up of direct costs for combined antiretroviral therapy, cART, -regimens in the nationwide long-term observational multi-centre German HIV ClinSurv Cohort. The second aim was to develop potential cost saving strategies by modelling different treatment scenarios. Antiretroviral regimens (ART) from 10,190 HIV-infected patients from 11 participating ClinSurv study centres have been investigated since 1996. Biannual data cART-initiation, cART-changes, surrogate markers, clinical events and the Centre of Disease Control- (CDC)-stage of HIV disease are reported. Treatment duration was calculated on a daily basis via the documented dates for the beginning and end of each antiretroviral drug treatment. Prices were calculated for each individual regimen based on actual office sales prices of the branded pharmaceuticals distributed by the license holder including German taxes. During the 13-year follow-up period, 21,387,427 treatment days were covered. Cumulative direct costs for antiretroviral drugs of €812,877,356 were determined according to an average of €42.08 per day (€7.52 to € 217.70). Since cART is widely used in Germany, the costs for an entire regimen increased by 13.5%. Regimens are more expensive in the advanced stages of HIV disease. The potential for cost savings was calculated using non-nucleotide-reverse-transcriptase-inhibitor, NNRTI, more frequently instead of ritonavir-boosted protease inhibitor, PI/r, in first line therapy. This calculation revealed cumulative savings of 10.9% to 19.8% of daily treatment costs (50% and 90% substitution of PI/r, respectively). Substituting certain branded drugs by generic drugs showed potential cost savings of between 1.6% and 31.8%. Analysis of the data of this nationwide study reflects disease-specific health services research and will give insights into the cost impacts of

  10. Drug transporter gene expression in human colorectal tissue and cell lines: modulation with antiretrovirals for microbicide optimization.

    Science.gov (United States)

    Mukhopadhya, Indrani; Murray, Graeme I; Berry, Susan; Thomson, John; Frank, Bruce; Gwozdz, Garry; Ekeruche-Makinde, Julia; Shattock, Robin; Kelly, Charles; Iannelli, Francesco; Pozzi, Gianni; El-Omar, Emad M; Hold, Georgina L; Hijazi, Karolin

    2016-02-01

    The objectives of this study were to comprehensively assess mRNA expression of 84 drug transporters in human colorectal biopsies and six representative cell lines, and to investigate the alteration of drug transporter gene expression after exposure to three candidate microbicidal antiretroviral (ARV) drugs (tenofovir, darunavir and dapivirine) in the colorectal epithelium. The outcome of the objectives informs development of optimal ARV-based microbicidal formulations for prevention of HIV-1 infection. Drug transporter mRNA expression was quantified from colorectal biopsies and cell lines by quantitative real-time PCR. Relative mRNA expression was quantified in Caco-2 cells and colorectal explants after induction with ARVs. Data were analysed using Pearson's product moment correlation (r), hierarchical clustering and principal component analysis (PCA). Expression of 58 of the 84 transporters was documented in colorectal biopsies, with genes for CNT2, P-glycoprotein (P-gp) and MRP3 showing the highest expression. No difference was noted between individual subjects when analysed by age, gender or anatomical site (rectum or recto-sigmoid) (r = 0.95-0.99). High expression of P-gp and CNT2 proteins was confirmed by immunohistochemical staining. Similarity between colorectal tissue and cell-line drug transporter gene expression was variable (r = 0.64-0.84). PCA showed distinct clustering of human colorectal biopsy samples, with the Caco-2 cells defined as the best surrogate system. Induction of Caco-2 cell lines with ARV drugs suggests that darunavir-based microbicides incorporating tenofovir may result in drug-drug interactions likely to affect distribution of individual drugs to sub-epithelial target cells. These findings will help optimize complex formulations of rectal microbicides to realize their full potential as an effective approach for pre-exposure prophylaxis against HIV-1 infection. © The Author 2015. Published by Oxford University Press on behalf of the

  11. HIV-1 drug resistance genotyping from antiretroviral therapy (ART naïve and first-line treatment failures in Djiboutian patients

    Directory of Open Access Journals (Sweden)

    Elmi Abar Aden

    2012-10-01

    Full Text Available Abstract In this study we report the prevalence of antiretroviral drug resistant HIV-1 genotypes of virus isolated from Djiboutian patients who failed first-line antiretroviral therapy (ART and from ART naïve patients. Patients and methods A total of 35 blood samples from 16 patients who showed first-line ART failure (>1000 viral genome copies/ml and 19 ART-naïve patients were collected in Djibouti from October 2009 to December 2009. Both the protease (PR and reverse transcriptase (RT genes were amplified and sequenced using National Agency for AIDS Research (ANRS protocols. The Stanford HIV database algorithm was used for interpretation of resistance data and genotyping. Results Among the 16 patients with first-line ART failure, nine (56.2% showed reverse transcriptase inhibitor-resistant HIV-1 strains: two (12.5% were resistant to nucleoside (NRTI, one (6.25% to non-nucleoside (NNRTI reverse transcriptase inhibitors, and six (37.5% to both. Analysis of the DNA sequencing data indicated that the most common mutations conferring drug resistance were M184V (38% for NRTI and K103N (25% for NNRTI. Only NRTI primary mutations K101Q, K103N and the PI minor mutation L10V were found in ART naïve individuals. No protease inhibitor resistant strains were detected. In our study, we found no detectable resistance in ∼ 44% of all patients who experienced therapeutic failure which was explained by low compliance, co-infection with tuberculosis and malnutrition. Genotyping revealed that 65.7% of samples were infected with subtype C, 20% with CRF02_AG, 8.5% with B, 2.9% with CRF02_AG/C and 2.9% with K/C. Conclusion The results of this first study about drug resistance mutations in first-line ART failures show the importance of performing drug resistance mutation test which guides the choice of a second-line regimen. This will improve the management of HIV-infected Djiboutian patients. Virtual slides The virtual slide(s for this article can be found

  12. Counterfeiting as corporate externality: intellectual property crime and global insecurity

    OpenAIRE

    2010-01-01

    Abstract Corporate negative externalities occur when corporations place some of the costs of their profit-seeking activity onto society. This paper suggests that the current global problem of intellectual property crime is such an externality, and that it has not been recognised as such because corporations present product counterfeiting and piracy as crimes which reduce their revenue, rather than as predictable side effects of corporate production and merchandising, including bran...

  13. Barriers to antiretroviral treatment access for injecting drug users living with HIV in Chennai, South India.

    Science.gov (United States)

    Chakrapani, Venkatesan; Velayudham, Jaikumar; Shunmugam, Murali; Newman, Peter A; Dubrow, Robert

    2014-01-01

    India's National AIDS Control Organization provides free antiretroviral treatment (ART) to people living with HIV (PLHIV), including members of marginalized groups such as injecting drug users (IDUs). To help inform development of interventions to enhance ART access, we explored barriers to free ART access at government ART centers for IDUs living with HIV in Chennai by conducting three focus groups (n = 19 IDUs) and four key informant interviews. Data were explored using framework analysis to identify categories and derive themes. We found interrelated barriers at the family and social, health-care system, and individual levels. Family and social level barriers included lack of family support and fear of societal discrimination, as well as unmet basic needs, including food and shelter. Health-care system barriers included actual or perceived unfriendly hospital environment and procedures such as requiring proof of address and identity from PLHIV, including homeless IDUs; provider perception that IDUs will not adhere to ART, resulting in ART not being initiated; actual or perceived inadequate counseling services and lack of confidentiality; and lack of effective linkages between ART centers, needle/syringe programs, and drug dependence treatment centers. Individual-level barriers included active drug use, lack of self-efficacy in ART adherence, low motivation to initiate ART stemming from a fatalistic attitude, and inadequate knowledge about ART. These findings indicate that to facilitate IDUs gaining access to ART, systemic changes are needed, including steps to make the environment and procedures at government ART centers more IDU-friendly and steps to decrease HIV- and drug use-related stigma and discrimination faced by IDUs from the general public and health-care providers. Housing support for homeless IDUs and linkage of IDUs with drug dependence treatment are also essential.

  14. Neuropsychological functioning and antiretroviral treatment in HIV/AIDS: a review.

    Science.gov (United States)

    Cysique, Lucette A; Brew, Bruce J

    2009-06-01

    This article presents a review of studies that have investigated the neuropsychological effects of antiretroviral treatment (ART) for HIV-1 infection. It provides a brief overview of the era of monotherapy, dual-therapy, and an extended overview of the current era of combination antiretroviral therapy (CART). This review highlights that while CART has had a dramatic effect on the incidence and the severity of HIV-associated neurocognitive disorders (HAND), HAND, in its mild form, still remains prevalent. New causes of this sustained prevalence are poor CNS penetration of some antiretroviral agents, drug resistance, poor adherence, potential neurotoxicity, co-morbidities such as the long-term CART side effects in relation to cardio-vascular disease, and chronic HIV brain infection that may facilitate the expression of new forms of neurodegenerative processes. The review emphasizes the need to address methodological limitations of published studies and the need for large and representative cross-disciplinary longitudinal investigations across the HIV illness span.

  15. Update on HIV-1 acquired and transmitted drug resistance in Africa.

    Science.gov (United States)

    Ssemwanga, Deogratius; Lihana, Raphael W; Ugoji, Chinenye; Abimiku, Alash'le; Nkengasong, John; Dakum, Patrick; Ndembi, Nicaise

    2015-01-01

    The last ten years have witnessed a significant scale-up and access to antiretroviral therapy in Africa, which has improved patient quality of life and survival. One major challenge associated with increased access to antiretroviral therapy is the development of antiretroviral resistance due to inconsistent drug supply and/or poor patient adherence. We review the current state of both acquired and transmitted drug resistance in Africa over the past ten years (2001-2011) to identify drug resistance associated with the different drug regimens used on the continent and to help guide affordable strategies for drug resistance surveillance. A total of 161 references (153 articles, six reports and two conference abstracts) were reviewed. Antiretroviral resistance data was available for 40 of 53 African countries. A total of 5,541 adult patients from 99 studies in Africa were included in this analysis. The pooled prevalence of drug resistance mutations in Africa was 10.6%, and Central Africa had the highest prevalence of 54.9%. The highest prevalence of nucleoside reverse transcriptase inhibitor mutations was in the west (55.3%) and central (54.8%) areas; nonnucleoside reverse transcriptase inhibitor mutations were highest in East Africa (57.0%) and protease inhibitors mutations highest in Southern Africa (16.3%). The major nucleoside reverse transcriptase inhibitor mutation in all four African regions was M184V. Major nonnucleoside reverse transcriptase inhibitor as well as protease inhibitor mutations varied by region. The prevalence of drug resistance has remained low in several African countries although the emergence of drug resistance mutations varied across countries. Continued surveillance of antiretroviral therapy resistance remains crucial in gauging the effectiveness of country antiretroviral therapy programs and strategizing on effective and affordable strategies for successful treatment.

  16. Hematological alterations and thymic function in newborns of HIV-infected mothers receiving antiretroviral drugs.

    Science.gov (United States)

    Wongnoi, Rotjanee; Penvieng, Nawaporn; Singboottra, Panthong; Kingkeow, Doungnapa; Oberdorfer, Peninnah; Sirivatanapa, Pannee; Pornprasert, Sakorn

    2013-06-08

    To investigate the effects of antiretroviral (ARV) drugs on hematological parameters and thymic function in HIV-uninfected newborns of HIV-infected mothers. Cross sectional study. Chiang-Mai University Hospital, Chiang-Mai, Thailand. 49 HIV-uninfected and 26 HIV-infected pregnancies. Cord blood samples of newborns from HIV-uninfected and HIV-infected mothers were collected. Hematological parameters were measured using automatic blood cell count. T-cell receptor excision circles (TRECs) levels in cord blood mononuclear cells (CBMCs), CD4+ and CD8+ T-cells were quantified using real-time PCR.. Hemotological parameters and thymic function. Newborn of HIV-infected mother tended to have lower mean levels of hemoglobin than those of HIV-uninfected mother (137 ±22 vs 146 ±17 g/L, P = 0.05). Furthermore, mean of red blood cell (RBC) counts and hematocrit and median of TRECs in CD4+ T-cells in the newborns of the former were significantly lower than those of the latter [3.6 ±0.7 vs 4.8 ±0.6 x 1012 cells/L, P cells) in HIV-uninfected newborns of HIV-infected mothers.

  17. HIV drug resistance following a decade of the free antiretroviral therapy programme in India: A review.

    Science.gov (United States)

    Karade, Santosh; Chaturbhuj, Devidas N; Sen, Sourav; Joshi, Rajneesh K; Kulkarni, Smita S; Shankar, Subramanian; Gangakhedkar, Raman R

    2018-01-01

    The objective of this review was to assess the burden of HIV drug resistance mutations (DRM) in Indian adults exposed to first-line antiretroviral therapy (ART) as per national guidelines. An advanced search of the published literature on HIV drug resistance in India was performed in the PubMed and Scopus databases. Data pertaining to age, sex, CD4 count, viral load, and prevalence of nucleoside reverse transcriptase inhibitor (NRTI)/non-nucleoside reverse transcriptase inhibitor (NNRTI) DRM were extracted from each publication. Year-wise Indian HIV-1 reverse transcriptase (RT) sequences were retrieved from the Los Alamos HIV database and mutation analyses were performed. A time trend analysis of the proportion of sequences showing NRTI resistance mutations among individuals exposed to first-line ART was conducted. Overall, 23 studies (1046 unique RT sequences) were identified indicating a prevalence of drug resistance to NRTI and NNRTI. The proportion of RT sequences with any DRM, any NRTI DRM, and any NNRTI DRM was 78.39%, 68.83%, and 73.13%, respectively. The temporal trend analysis of individual DRM from sequences retrieved during 2004-2014 indicated a rising trend in K65R mutations (p=0.013). Although the overall burden of resistance against first-line ART agents remained steady over the study decade, periodic monitoring is essential. There is the need to develop an HIV-1 subtype C-specific resistance database in India. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  18. The need for second-line antiretroviral therapy in adults in sub-Saharan Africa up to 2030: a mathematical modelling study.

    Science.gov (United States)

    Estill, Janne; Ford, Nathan; Salazar-Vizcaya, Luisa; Haas, Andreas D; Blaser, Nello; Habiyambere, Vincent; Keiser, Olivia

    2016-03-01

    The number of patients in need of second-line antiretroviral drugs is increasing in sub-Saharan Africa. We aimed to project the need of second-line antiretroviral therapy in adults in sub-Saharan Africa up to 2030. We developed a simulation model for HIV and applied it to each sub-Saharan African country. We used the WHO country intelligence database to estimate the number of adult patients receiving antiretroviral therapy from 2005 to 2014. We fitted the number of adult patients receiving antiretroviral therapy to observed estimates, and predicted first-line and second-line needs between 2015 and 2030. We present results for sub-Saharan Africa, and eight selected countries. We present 18 scenarios, combining the availability of viral load monitoring, speed of antiretroviral scale-up, and rates of retention and switching to second-line. HIV transmission was not included. Depending on the scenario, 8·7-25·6 million people are expected to receive antiretroviral therapy in 2020, of whom 0·5-3·0 million will be receiving second-line antiretroviral therapy. The proportion of patients on treatment receiving second-line therapy was highest (15·6%) in the scenario with perfect retention and immediate switching, no further scale-up, and universal routine viral load monitoring. In 2030, the estimated range of patients receiving antiretroviral therapy will remain constant, but the number of patients receiving second-line antiretroviral therapy will increase to 0·8-4·6 million (6·6-19·6%). The need for second-line antiretroviral therapy was two to three times higher if routine viral load monitoring was implemented throughout the region, compared with a scenario of no further viral load monitoring scale-up. For each monitoring strategy, the future proportion of patients receiving second-line antiretroviral therapy differed only minimally between countries. Donors and countries in sub-Saharan Africa should prepare for a substantial increase in the need for second

  19. The internet trade of counterfeit spirits in Russia - an emerging problem undermining alcohol, public health and youth protection policies?

    Science.gov (United States)

    Neufeld, Maria; Lachenmeier, Dirk W; Walch, Stephan G; Rehm, Jürgen

    2017-01-01

    Counterfeit alcohol belongs to the category of unrecorded alcohol not reflected in official statistics. The internet trade of alcoholic beverages has been prohibited by the Russian Federation since 2007, but various sellers still offer counterfeit spirits (i.e., forged brand spirits) over the internet to Russian consumers, mostly in a non-deceptive fashion at prices up to 15 times lower than in regular sale. The public health issues arising from this unregulated trade include potential harm to underage drinkers, hazards due to toxic ingredients such as methanol, but most importantly alcohol harms due to potentially increased drinking volumes due to low prices and high availability on the internet. The internet sale also undermines existing alcohol policies such as restrictions of sale locations, sale times and minimum pricing. The need to enforce measures against counterfeiting of spirits, but specifically their internet trade should be implemented as key elements of alcohol policies to reduce unrecorded alcohol consumption, which is currently about 33 % of total consumption in Russia.

  20. Interruption of antiretroviral therapy is associated with increased plasma cystatin C

    DEFF Research Database (Denmark)

    Mocroft, Amanda; Wyatt, Christina; Szczech, Lynda

    2009-01-01

    BACKGROUND: Cystatin C has been proposed as an alternative marker of renal function. We sought to determine whether participants randomized to episodic use of antiretroviral therapy guided by CD4 cell count (drug conservation) had altered cystatin C levels compared with those randomized to contin...

  1. The temperature-sensitive luminescence of (Y,Gd)VO4:Bi3+,Eu3+ and its application for stealth anti-counterfeiting

    International Nuclear Information System (INIS)

    Chen, Lei; Zhang, Yao; Luo, Anqi; Liu, Fayong; Jiang, Yang; Hu, Qingzhuo; Chen, Shifu; Liu, Ru-Shi

    2012-01-01

    Anti-counterfeiting technologies are desired to protect products far away from the violation of dummy, fake and shoddy goods. The phosphor of (Y,Gd)VO 4 :Bi 3+ ,Eu 3+ was synthesized for the application of this purpose. Its photoluminescence was investigated by exciting with different wavelengths at variant temperatures. Wide emission color ranged from green through yellow to orange was tuned up by tailor-ing Bi 3+ and Eu 3+ concentrations. The temperature dependent luminescence and wavelength selective excitation of (Y,Gd)VO 4 :Bi 3+ ,Eu 3+ were observed, which provide different encryptions in anti-counterfeiting. To verify the feasibility in application, two anti-counterfeiting patterns were fabricated practically and excellent performance was obtained. Moreover, the physical mechanisms for the different phenomena of luminescence were elucidated from excitation spectra combining with the configuration coordinate model. (copyright 2012 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim) (orig.)

  2. Detection of Counterfeit Tequila by Fluorescence Spectroscopy

    Directory of Open Access Journals (Sweden)

    José Manuel de la Rosa Vázquez

    2015-01-01

    Full Text Available An ultraviolet (UV light induced fluorescence study to discriminate fake tequila from genuine ones is presented. A portable homemade system based on four light emitting diodes (LEDs from 255 to 405 nm and a miniature spectrometer was used. It has been shown that unlike fake and silver tequila, which produce weak fluorescence signal, genuine mixed, rested, and aged tequilas show high fluorescence emission in the range from 400 to 750 nm. The fluorescence intensity grows with aging in 100% agave tequila. Such fluorescence differences can even be observed with naked eyes. The presented results demonstrate that the fluorescence measurement could be a good method to detect counterfeit tequila.

  3. Renal impairment in a rural African antiretroviral programme

    Directory of Open Access Journals (Sweden)

    Lessells Richard J

    2009-08-01

    Full Text Available Abstract Background There is little knowledge regarding the prevalence and nature of renal impairment in African populations initiating antiretroviral treatment, nor evidence to inform the most cost effective methods of screening for renal impairment. With the increasing availability of the potentially nephrotixic drug, tenofovir, such information is important for the planning of antiretroviral programmes Methods (i Retrospective review of the prevalence and risk factors for impaired renal function in 2189 individuals initiating antiretroviral treatment in a rural African setting between 2004 and 2007 (ii A prospective study of 149 consecutive patients initiating antiretrovirals to assess the utility of urine analysis for the detection of impaired renal function. Severe renal and moderately impaired renal function were defined as an estimated GFR of ≤ 30 mls/min/1.73 m2 and 30–60 mls/min/1.73 m2 respectively. Logistic regression was used to determine odds ratio (OR of significantly impaired renal function (combining severe and moderate impairment. Co-variates for analysis were age, sex and CD4 count at initiation. Results (i There was a low prevalence of severe renal impairment (29/2189, 1.3% 95% C.I. 0.8–1.8 whereas moderate renal impairment was more frequent (287/2189, 13.1% 95% C.I. 11.6–14.5 with many patients having advanced immunosuppression at treatment initiation (median CD4 120 cells/μl. In multivariable logistic regression age over 40 (aOR 4.65, 95% C.I. 3.54–6.1, male gender (aOR 1.89, 95% C.I. 1.39–2.56 and CD4 Conclusion In this rural African setting, significant renal impairment is uncommon in patients initiating antiretrovirals. Urine analysis alone may be inadequate for identification of those with impaired renal function where resources for biochemistry are limited.

  4. Opportunistic disease and mortality in patients coinfected with hepatitis B or C virus in the strategic management of antiretroviral therapy (SMART) study

    DEFF Research Database (Denmark)

    Tedaldi, Ellen; Peters, Lars; Neuhaus, Jacquie

    2008-01-01

    BACKGROUND: In the Strategic Management of Antiretroviral Therapy (SMART) study, the risk of opportunistic disease (OD) and/or death due to any cause was elevated in the drug conservation (i.e., interrupt antiretroviral therapy until the CD4(+) cell count is

  5. Individualization of antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Pavlos R

    2011-12-01

    Full Text Available Rebecca Pavlos, Elizabeth J PhillipsInstitute for Immunology and Infectious Diseases, Murdoch University, Murdoch, Western Australia, AustraliaAbstract: Antiretroviral therapy (ART has evolved considerably over the last three decades. From the early days of monotherapy with high toxicities and pill burdens, through to larger pill burdens and more potent combination therapies, and finally, from 2005 and beyond where we now have the choice of low pill burdens and once-daily therapies. More convenient and less toxic regimens are also becoming available, even in resource-poor settings. An understanding of the individual variation in response to ART, both efficacy and toxicity, has evolved over this time. The strong association of the major histocompatibility class I allele HLA-B*5701 and abacavir hypersensitivity, and its translation and use in routine HIV clinical practice as a predictive marker with 100% negative predictive value, has been a success story and a notable example of the challenges and triumphs in bringing pharmacogenetics to the clinic. In real clinical practice, however, it is going to be the exception rather than the rule that individual biomarkers will definitively guide patient therapy. The need for individualized approaches to ART has been further increased by the importance of non-AIDS comorbidities in HIV clinical practice. In the future, the ideal utilization of the individualized approach to ART will likely consist of a combined approach using a combination of knowledge of drug, virus, and host (pharmacogenetic and pharmacoecologic [factors in the individual's environment that may be dynamic over time] information to guide the truly personalized prescription. This review will focus on our knowledge of the pharmacogenetics of the efficacy and toxicity of currently available antiretroviral agents and the current and potential utility of such information and approaches in present and future HIV clinical care.Keywords: HIV

  6. Frequency of Antiretroviral Resistance Mutations among Infants Exposed to Single-Dose Nevirapine and Short Course Maternal Antiretroviral Regimens: ACTG A5207.

    Science.gov (United States)

    Hitti, Jane; Halvas, Elias K; Zheng, Lu; Panousis, Constantinos G; Kabanda, Joseph; Taulo, Frank; Kumarasamy, Nagalingeswaran; Pape, Jean William; Lalloo, Umesh; Sprenger, Heather; Klingman, Karin L; Chan, Ellen S; McMahon, Deborah; Mellors, John W

    2014-11-01

    Intrapartum single-dose nevirapine (sdNVP) reduces HIV-1 perinatal transmission but selects NVP resistance among mothers and infants. We evaluated the frequency of antiretroviral resistance among infants with intrauterine HIV-1 infection exposed to sdNVP and maternal antenatal or breastfeeding antiretroviral therapy. This analysis included 429 infants from sub-Saharan Africa, India and Haiti whose 422 mothers received sdNVP plus maternal study treatment. At entry mothers had CD4>250/μL and were ART-naïve except for antenatal ZDV per local standard of care. Maternal study treatment started intrapartum and included ZDV/3TC, TDF/FTC or LPV/r for 7 or 21 days in a randomized factorial design. Infants received sdNVP study treatment and ZDV if local standard of care. Infant HIV RNA or DNA PCR and samples for genotype were obtained at birth and weeks 2, 4 and 12; infants who ever breast-fed were also tested at weeks 16, 24, 48 and 96. Samples from HIV-1-infected infants were tested for drug resistance by population genotype (ViroSeq). NVP or NRTI resistance mutations were assessed using the IAS-USA mutation list. Perinatal HIV-1 transmission occurred in 17 (4.0%) infants including 12 intrauterine infections. Resistance mutations were detected among 5 (42%) intrauterine-infected infants; of these, 3 had mutations conferring resistance to NVP alone, 1 had resistance to NRTI alone, and 1 had dual-class resistance mutations. Among the 2 infants with NRTI mutations, one (K70R) was likely maternally transmitted and one (K65R) occurred in the context of breastfeeding exposure to maternal antiretroviral therapy. Infants with intrauterine HIV infection are at risk of acquiring resistance mutations from exposure to maternal antiretroviral medications intrapartum and/or during breastfeeding. New approaches are needed to lower the risk of antiretroviral resistance in these infants.

  7. Prevalence of HIV Antiretroviral Drug Resistance and Its Impacts on HIV-1 Virological Failures in Jiangsu, China: A Cross-Sectional Study

    Directory of Open Access Journals (Sweden)

    Ying Zhou

    2016-01-01

    Full Text Available Antiretroviral therapy (ART has been shown to improve survival of patients with Human Immunodeficiency Virus (HIV infection and to reduce HIV-1 transmission. Therefore, the Chinese central government initiated a national program to provide ART free of charge to HIV-1 patients. We conducted a cross-sectional survey in Jiangsu province to determine the level of drug resistance (DR in HIV-1 infected patients and the correlates of DR in virological failures in 2012. Approximately 10.4% of the HIV-1 patients in the study experienced virological failure after one year of ART and were divided into drug sensitive and drug resistant groups based on genotype determination. The viral loads (VLs in the drug resistant group were significantly lower than the drug sensitive group. There were two independent predictors of virological failure: male gender and increasing duration of treatment. The primary mutations observed in the study were against nucleoside reverse transcriptase inhibitors (NRTIs which were M184V (79.45% and K103N (33.70% in nonnucleoside reverse transcriptase inhibitors (NNRTIs. The overall rate of DR in Jiangsu province is still relatively low among treated patients. However, close monitoring of drug resistance in male patients in the early stages of treatment is vital to maintaining and increasing the benefits of HIV ART achieved to date.

  8. PREFACE: Anti-counterfeit Image Analysis Methods (A Special Session of ICSXII)

    Science.gov (United States)

    Javidi, B.; Fournel, T.

    2007-06-01

    The International Congress for Stereology is dedicated to theoretical and applied aspects of stochastic tools, image analysis and mathematical morphology. A special emphasis on `anti-counterfeit image analysis methods' has been given this year for the XIIth edition (ICSXII). Facing the economic and social threat of counterfeiting, this devoted session presents recent advances and original solutions in the field. A first group of methods are related to marks located either on the product (physical marks) or on the data (hidden information) to be protected. These methods concern laser fs 3D encoding and source separation for machine-readable identification, moiré and `guilloche' engraving for visual verification and watermarking. Machine-readable travel documents are well-suited examples introducing the second group of methods which are related to cryptography. Used in passports for data authentication and identification (of people), cryptography provides some powerful tools. Opto-digital processing allows some efficient implementations described in the papers and promising applications. We would like to thank the reviewers who have contributed to a session of high quality, and the authors for their fine and hard work. We would like to address some special thanks to the invited lecturers, namely Professor Roger Hersch and Dr Isaac Amidror for their survey of moiré methods, Prof. Serge Vaudenay for his survey of existing protocols concerning machine-readable travel documents, and Dr Elisabet Pérez-Cabré for her presentation on optical encryption for multifactor authentication. We also thank Professor Dominique Jeulin, President of the International Society for Stereology, Professor Michel Jourlin, President of the organizing committee of ICSXII, for their help and advice, and Mr Graham Douglas, the Publisher of Journal of Physics: Conference Series at IOP Publishing, for his efficiency. We hope that this collection of papers will be useful as a tool to further

  9. Antiretroviral drug expenditure, pricing and judicial demand: an analysis of federal procurement data in Brazil from 2004–2011

    Science.gov (United States)

    2014-01-01

    Background Previous studies have described expenditures for antiretroviral (ARV) medicines in Brazil through 2005. While prior studies examined overall expenditures, they have not have analyzed drug procurement data in order to describe the role of court litigation on access and pricing. Methods ARV drug procurement from private sector sources for the years 2004–2011 was obtained through the general procurement database of the Brazilian Federal Government (SIASG). Procurement was measured in Defined Daily Doses (DDD) per 1000 persons-under-treatment per day. Expenditures and price per DDD were calculated and expressed in U.S. Dollars. Justifications for ARV purchases were examined in order to determine the relationship between health litigation and incorporation into Brazil’s national treatment guidelines. Results Drug procurement of ARVs from private sources underwent marked expansion in 2005, peaked in 2009, and stabilized to 2008 levels by 2011. Expenditures followed procurement curves. Medications which were procured for the first time after 2007 cost more than medicines which were introduced before 2007. Judicial actions initially resulted in purchases of newer medications for a select number of patients in Brazil but ultimately expanded availability to a larger population through incorporation into the national treatment guidelines. Conclusions Drug procurement and expenditures for ARVs in Brazil varied between 2004–2011. The procurement of some drugs from the private sector ceased after public manufacturers started producing them locally. Judicial demand has resulted in the incorporation of newer drugs into the national treatment guidelines. In order for the AIDS treatment program to remain sustainable, efforts should be pursued to reduce prices through generic drugs, price negotiation and other public health flexibilities such as compulsory licensing. PMID:24735589

  10. Patterns of HIV-1 drug resistance after first-line antiretroviral therapy (ART) failure in 6 sub-Saharan African countries: implications for second-line ART strategies.

    Science.gov (United States)

    Hamers, Raph L; Sigaloff, Kim C E; Wensing, Annemarie M; Wallis, Carole L; Kityo, Cissy; Siwale, Margaret; Mandaliya, Kishor; Ive, Prudence; Botes, Mariette E; Wellington, Maureen; Osibogun, Akin; Stevens, Wendy S; Rinke de Wit, Tobias F; Schuurman, Rob

    2012-06-01

    Human immunodeficiency virus type 1 (HIV-1) drug resistance may limit the benefits of antiretroviral therapy (ART). This cohort study examined patterns of drug-resistance mutations (DRMs) in individuals with virological failure on first-line ART at 13 clinical sites in 6 African countries and predicted their impact on second-line drug susceptibility. A total of 2588 antiretroviral-naive individuals initiated ART consisting of different nucleoside reverse transcriptase inhibitor (NRTI) backbones (zidovudine, stavudine, tenofovir, or abacavir, plus lamivudine or emtricitabine) with either efavirenz or nevirapine. Population sequencing after 12 months of ART was retrospectively performed if HIV RNA was >1000 copies/mL. The 2010 International Antiviral Society-USA list was used to score major DRMs. The Stanford algorithm was used to predict drug susceptibility. HIV-1 sequences were generated for 142 participants who virologically failed ART, of whom 70% carried ≥1 DRM and 49% had dual-class resistance, with an average of 2.4 DRMs per sequence (range, 1-8). The most common DRMs were M184V (53.5%), K103N (28.9%), Y181C (15.5%), and G190A (14.1%). Thymidine analogue mutations were present in 8.5%. K65R was frequently selected by stavudine (15.0%) or tenofovir (27.7%). Among participants with ≥1 DRM, HIV-1 susceptibility was reduced in 93% for efavirenz/nevirapine, in 81% for lamivudine/emtricitabine, in 59% for etravirine/rilpivirine, in 27% for tenofovir, in 18% for stavudine, and in 10% for zidovudine. Early failure detection limited the accumulation of resistance. After stavudine failure in African populations, zidovudine rather than tenofovir may be preferred in second-line ART. Strategies to prevent HIV-1 resistance are a global priority.

  11. Does short-term virologic failure translate to clinical events in antiretroviral-naïve patients initiating antiretroviral therapy in clinical practice?

    DEFF Research Database (Denmark)

    NN, NN; Mugavero, Michael J; May, Margaret

    2008-01-01

    , nevirapine, lopinavir/ritonavir, nelfinavir, or abacavir as third drugs in combination with a zidovudine and lamivudine nucleoside reverse transcriptase inhibitor backbone. MAIN OUTCOME MEASURES: Short-term (24-week) virologic failure (>500 copies/ml) and clinical events within 2 years of ART initiation.......58-2.22), lopinavir/ritonavir (1.32, 95% CI = 1.12-1.57), nelfinavir (3.20, 95% CI = 2.74-3.74), and abacavir (2.13, 95% CI = 1.82-2.50). However, the rate of clinical events within 2 years of ART initiation appeared higher only with nevirapine (adjusted hazard ratio for composite outcome measure 1.27, 95% CI = 1......OBJECTIVE: To determine whether differences in short-term virologic failure among commonly used antiretroviral therapy (ART) regimens translate to differences in clinical events in antiretroviral-naïve patients initiating ART. DESIGN: Observational cohort study of patients initiating ART between...

  12. The internet trade of counterfeit spirits in Russia – an emerging problem undermining alcohol, public health and youth protection policies?

    Science.gov (United States)

    Neufeld, Maria; Lachenmeier, Dirk W.; Walch, Stephan G.; Rehm, Jürgen

    2017-01-01

    Counterfeit alcohol belongs to the category of unrecorded alcohol not reflected in official statistics. The internet trade of alcoholic beverages has been prohibited by the Russian Federation since 2007, but various sellers still offer counterfeit spirits (i.e., forged brand spirits) over the internet to Russian consumers, mostly in a non-deceptive fashion at prices up to 15 times lower than in regular sale. The public health issues arising from this unregulated trade include potential harm to underage drinkers, hazards due to toxic ingredients such as methanol, but most importantly alcohol harms due to potentially increased drinking volumes due to low prices and high availability on the internet. The internet sale also undermines existing alcohol policies such as restrictions of sale locations, sale times and minimum pricing. The need to enforce measures against counterfeiting of spirits, but specifically their internet trade should be implemented as key elements of alcohol policies to reduce unrecorded alcohol consumption, which is currently about 33 % of total consumption in Russia. PMID:28663784

  13. Governance on the Drug Supply Chain via Gcoin Blockchain.

    Science.gov (United States)

    Tseng, Jen-Hung; Liao, Yen-Chih; Chong, Bin; Liao, Shih-Wei

    2018-05-23

    As a trust machine, blockchain was recently introduced to the public to provide an immutable, consensus based and transparent system in the Fintech field. However, there are ongoing efforts to apply blockchain to other fields where trust and value are essential. In this paper, we suggest Gcoin blockchain as the base of the data flow of drugs to create transparent drug transaction data. Additionally, the regulation model of the drug supply chain could be altered from the inspection and examination only model to the surveillance net model, and every unit that is involved in the drug supply chain would be able to participate simultaneously to prevent counterfeit drugs and to protect public health, including patients.

  14. Analysis of drug-drug interactions among patients receiving antiretroviral regimens using data from a large open-source prescription database.

    Science.gov (United States)

    Patel, Nimish; Borg, Peter; Haubrich, Richard; McNicholl, Ian

    2018-06-14

    Results of a study of contraindicated concomitant medication use among recipients of preferred antiretroviral therapy (ART) regimens are reported. A retrospective study was conducted to evaluate concomitant medication use in a cohort of previously treatment-naive, human immunodeficiency virus (HIV)-infected U.S. patients prescribed preferred ART regimens during the period April 2014-March 2015. Data were obtained from a proprietary longitudinal prescription database; elements retrieved included age, sex, and prescription data. The outcome of interest was the frequency of drug-drug interactions (DDIs) associated with concomitant use of contraindicated medications. Data on 25,919 unique treatment-naive patients who used a preferred ART regimen were collected. Overall, there were 384 instances in which a contraindicated medication was dispensed for concurrent use with a recommended ART regimen. Rates of contraindicated concomitant medication use differed significantly by ART regimen; the highest rate (3.2%) was for darunavir plus ritonavir plus emtricitabine-tenofovir disoproxil fumarate (DRV plus RTV plus FTC/TDF), followed by elvitegravir-cobicistat-emtricitabine-tenofovir disoproxil fumarate (EVG/c/FTC/TDF)(2.8%). The highest frequencies of DDIs were associated with ART regimens that included a pharmacoenhancing agent: DRV plus RTV plus FTC/TDF (3.2%) and EVG/c/FTC/TDF (2.8%). In a large population of treatment-naive HIV-infected patients, ART regimens that contained a pharmacoenhancing agent were involved most frequently in contraindicated medication-related DDIs. All of the DDIs could have been avoided by using therapeutic alternatives within the same class not associated with a DDI. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  15. Initial Virologic Response and HIV Drug Resistance Among HIV-Infected Individuals Initiating First-line Antiretroviral Therapy at 2 Clinics in Chennai and Mumbai, India

    Science.gov (United States)

    Hingankar, Nitin K.; Thorat, Smita R.; Deshpande, Alaka; Rajasekaran, S.; Chandrasekar, C.; Kumar, Suria; Srikantiah, Padmini; Chaturbhuj, Devidas N.; Datkar, Sharda R.; Deshmukh, Pravin S.; Kulkarni, Smita S.; Sane, Suvarna; Reddy, D. C. S.; Garg, Renu; Jordan, Michael R.; Kabra, Sandhya; Paranjape, Ramesh S.

    2012-01-01

    Human immunodeficiency virus drug resistance (HIVDR) in cohorts of patients initiating antiretroviral therapy (ART) at clinics in Chennai and Mumbai, India, was assessed following World Health Organization (WHO) guidelines. Twelve months after ART initiation, 75% and 64.6% of participants at the Chennai and Mumbai clinics, respectively, achieved viral load suppression of Mumbai due to high rates of loss to follow-up. Findings highlight the need for defaulter tracing and scale-up of routine viral load testing to identify patients failing first-line ART. PMID:22544202

  16. Antiretroviral therapy during pregnancy and the risk of an adverse outcome.

    Science.gov (United States)

    Tuomala, Ruth E; Shapiro, David E; Mofenson, Lynne M; Bryson, Yvonne; Culnane, Mary; Hughes, Michael D; O'Sullivan, M J; Scott, Gwendolyn; Stek, Alice M; Wara, Diane; Bulterys, Marc

    2002-06-13

    Some studies suggest that combination antiretroviral therapy in pregnant women with human immunodeficiency virus type 1 (HIV-1) infection increases the risk of premature birth and other adverse outcomes of pregnancy. We studied pregnant women with HIV-1 infection who were enrolled in seven clinical studies and delivered their infants from 1990 through 1998. The cohort comprised 2123 women who received antiretroviral therapy during pregnancy (monotherapy in 1590, combination therapy without protease inhibitors in 396, and combination therapy with protease inhibitors in 137) and 1143 women who did not receive antiretroviral therapy. After standardization for the CD4+ cell count and use or nonuse of tobacco, alcohol, and illicit drugs, the rate of premature delivery (women who received antiretroviral therapy and those who did not (16 percent and 17 percent, respectively); the rate of low birth weight (women who received combination therapy with protease inhibitors (5 percent) had infants with very low birth weight, as compared with nine women who received combination therapy without protease inhibitors (2 percent) (adjusted odds ratio, 3.56; 95 percent confidence interval, 1.04 to 12.19). As compared with no antiretroviral therapy or monotherapy, combination therapy for HIV-1 infection in pregnant women is not associated with increased rates of premature delivery or with low birth weight, low Apgar scores, or stillbirth in their infants. The association between combination therapy with protease inhibitors and an increased risk of very low birth weight requires confirmation.

  17. CUE: counterfeit-resistant usable eye movement-based authentication via oculomotor plant characteristics and complex eye movement patterns

    Science.gov (United States)

    Komogortsev, Oleg V.; Karpov, Alexey; Holland, Corey D.

    2012-06-01

    The widespread use of computers throughout modern society introduces the necessity for usable and counterfeit-resistant authentication methods to ensure secure access to personal resources such as bank accounts, e-mail, and social media. Current authentication methods require tedious memorization of lengthy pass phrases, are often prone to shouldersurfing, and may be easily replicated (either by counterfeiting parts of the human body or by guessing an authentication token based on readily available information). This paper describes preliminary work toward a counterfeit-resistant usable eye movement-based (CUE) authentication method. CUE does not require any passwords (improving the memorability aspect of the authentication system), and aims to provide high resistance to spoofing and shoulder-surfing by employing the combined biometric capabilities of two behavioral biometric traits: 1) oculomotor plant characteristics (OPC) which represent the internal, non-visible, anatomical structure of the eye; 2) complex eye movement patterns (CEM) which represent the strategies employed by the brain to guide visual attention. Both OPC and CEM are extracted from the eye movement signal provided by an eye tracking system. Preliminary results indicate that the fusion of OPC and CEM traits is capable of providing a 30% reduction in authentication error when compared to the authentication accuracy of individual traits.

  18. AtriplaR/anti-TB combination in TB/HIV patients. Drug in focus

    Directory of Open Access Journals (Sweden)

    Semvua Hadija H

    2011-11-01

    Full Text Available Abstract Background Co-administration of anti-tuberculosis and antiretroviral therapy is often inevitable in high-burden countries where tuberculosis is the most common opportunistic infection associated with HIV/AIDS. Concurrent use of rifampicin and several antiretroviral drugs is complicated by pharmacokinetic drug-drug interaction. Method Pubmed and Google search following the key words tuberculosis, HIV, emtricitabine, tenofovir efavirenz, interaction were used to find relevant information on each drug of the fixed dose combination AtriplaR Results Information on generic name, trade name, pharmacokinetic parameter, metabolism and the pharmacokinetic interaction with Anti-TB drugs of emtricitabine, tenofovir, and efavirenz was obtained. Conclusion Fixed dose combination of emtricitabine/tenofovir/efavirenz (ATRIPLAR which has been approved by Food and Drug Administration shows promising results as far as safety and efficacy is concerned in TB/HIV co-infection patients, hence can be considered effective and safe antiretroviral drug in TB/HIV management for adult and children above 3 years of age.

  19. Relations of pursuance taking drug of HIV patients with the success of Antiretroviral Therapy (ART in Poli Serunai Hospital Dr. Achmad Muchtar Bukittinggi Year 2014

    Directory of Open Access Journals (Sweden)

    YELMI RENI PUTRI

    2016-06-01

    Full Text Available Relations of pursuance taking drug of HIV patients with the success of Antiretroviral Therapy (ART in Poli Serunai Hospital Dr. Achmad Muchtar Bukittinggi Year 2014 Yelmi Reni Putri, AdrianiProgram Studi Ilmu Keperawatan STIKes Fort De Kock BukittinggiEmail : Yelmi.reni@gmail.com ABSTRACT1st of of December is the day each year is celebrated as a day of HIV / AIDS this year themed "prevent HIV / AIDS, protect workers, families and the nation", this is when the right moment for us health workers give a good contribution to overcome or provide suggestions for improving services to patients with HIV / AIDS. The increasing number of patients with HIV / AIDS today is not only to make our health care workers need to be vigilant, even patients and families also need to work together to overcome this proble.The purpose of this study was to identify the level of compliance of patients taking antiretroviral drugs and HIV-positive people do with the success of antiretroviral therapy, the study sample taken in accident sampling with the number of respondents 40 patients idODHA of the month from May to October 2014. The study design using qualitative and quantitative method Mix , measuring instrument used in this research is a questionnaire that contains the characteristics of patients living with HIV, guided interviews to assess the role of the KPA, manager of HIV RSAM, and people living with HIV patients themselves.The result showed 57.5% of patients did not obey, and as much as 52.5% of patients successfully in HIV treatment, but there is no relationship between adherence with therapy success with value value 0.583 and 0.677 OR it is associated with the patient's anxiety and fear to know the results of which he repeated CD4 CD4 is one measure of the success of therapy. The conclusion of this study is important to know the patients' adherence PLWHA still low this will impact on the occurrence of resistance will even increase mortality, it is recommended

  20. Impact of low-level-viremia on HIV-1 drug-resistance evolution among antiretroviral treated-patients.

    Directory of Open Access Journals (Sweden)

    Constance Delaugerre

    Full Text Available BACKGROUND: Drug-resistance mutations (DRAM are frequently selected in patients with virological failure defined as viral load (pVL above 500 copies/ml (c/mL, but few resistance data are available at low-level viremia (LLV. Our objective was to determine the emergence and evolution of DRAM during LLV in HIV-1-infected patients while receiving antiretroviral therapy (ART. METHODS: Retrospective analysis of patients presenting a LLV episode defined as pVL between 40 and 500 c/mL on at least 3 occasions during a 6-month period or longer while on the same ART. Resistance genotypic testing was performed at the onset and at the end of LLV period. Emerging DRAM was defined during LLV if never detected on baseline genotype or before. RESULTS: 48 patients including 4 naive and 44 pretreated (median 9 years presented a LLV episode with a median duration of 11 months. Current ART included 2NRTI (94%, ritonavir-boosted PI (94%, NNRTI (23%, and/or raltegravir (19%. Median pVL during LLV was 134 c/mL. Successful resistance testing at both onset and end of the LLV episode were obtained for 37 patients (77%, among who 11 (30% acquired at least 1 DRAM during the LLV period: for NRTI in 6, for NNRTI in 1, for PI in 4, and for raltegravir in 2. During the LLV period, number of drugs with genotypic resistance increased from a median of 4.5 to 6 drugs. Duration and pVL level of LLV episode, duration of previous ART, current and nadir CD4 count, number of baseline DRAM and GSS were not identified as predictive factors of resistance acquisition during LLV, probably due to limited number of patients. CONCLUSION: Persistent LLV episodes below 500 c/ml while receiving ART is associated with emerging DRAM for all drug classes and a decreasing in further therapeutic options, suggesting to earlier consider resistance monitoring and ART optimization in this setting.

  1. Use of antiretroviral therapy and risk of end-stage liver disease and hepatocellular carcinoma in HIV-positive persons

    DEFF Research Database (Denmark)

    Nielsen, Lene Ryom; Lundgren, Jens Dilling; De Wit, Stéphane

    2016-01-01

    OBJECTIVES: Although several antiretroviral drugs, including the d-drugs stavudine (d4T) and didanosine (ddI), may cause biomarker-defined hepatotoxicity, their association with clinically defined end-stage liver disease (ESLD) and hepatocellular carcinoma (HCC) remains unknown. DESIGN: Prospective...

  2. Use of antiretroviral therapy and risk of end-stage liver disease and hepatocellular carcinoma in HIV-positive persons

    NARCIS (Netherlands)

    Ryom, Lene; Lundgren, Jens Dilling; de Wit, Stéphane; Kovari, Helen; Reiss, Peter; Law, Matthew; El-Sadr, Wafa; Monforte, Antonella D.'Arminio; Mocroft, Amanda; Smith, Colette; Fontas, Eric; Dabis, Francois; Phillips, Andrew; Sabin, Caroline

    2016-01-01

    Although several antiretroviral drugs, including the d-drugs stavudine (d4T) and didanosine (ddI), may cause biomarker-defined hepatotoxicity, their association with clinically defined end-stage liver disease (ESLD) and hepatocellular carcinoma (HCC) remains unknown. Prospective cohort study. Data

  3. Recent developments in counterfeits and imitations of Viagra, Cialis and Levitra. A 2005-2006 update

    NARCIS (Netherlands)

    Venhuis BJ; Barends DM; Zwaagstra ME; Kaste D de; Douane Laboratorium; KCF

    2007-01-01

    A strong trend is observed towards increasingly professional counterfeits and imitations of Viagra, Cialis and Levitra, with regard to the appearance of tablets, capsules and packaging. The professional presentation will deceive potential consumers into assuming these products are legal, efficacious

  4. Genotypic Characterization of Human Immunodeficiency Virus Type 1 Derived from Antiretroviral Drug-Treated Individuals Residing in Earthquake-Affected Areas in Nepal.

    Science.gov (United States)

    Negi, Bharat Singh; Kotaki, Tomohiro; Joshi, Sunil Kumar; Bastola, Anup; Nakazawa, Minato; Kameoka, Masanori

    2017-09-01

    Molecular epidemiological data on human immunodeficiency virus type 1 (HIV-1) are limited in Nepal and have not been available in areas affected by the April 2015 earthquake. Therefore, we conducted a genotypic study on HIV-1 genes derived from individuals on antiretroviral therapy residing in 14 districts in Nepal highly affected by the earthquake. HIV-1 genomic fragments were amplified from 40 blood samples of HIV treatment-failure individuals, and a sequencing analysis was performed on these genes. In the 40 samples, 29 protease, 32 reverse transcriptase, 25 gag, and 21 env genes were sequenced. HIV-1 subtyping revealed that subtype C (84.2%, 32/38) was the major subtype prevalent in the region, while CRF01_AE (7.9%, 3/38) and other recombinant forms (7.9%, 3/38) were also detected. In addition, major drug resistance mutations were identified in 21.9% (7/32) of samples, indicating the possible emergence of HIV-1 drug resistance in earthquake-affected areas in Nepal.

  5. Artemether-Lumefantrine Combination Therapy for Treatment of Uncomplicated Malaria: The Potential for Complex Interactions with Antiretroviral Drugs in HIV-Infected Individuals

    Directory of Open Access Journals (Sweden)

    Pauline Byakika-Kibwika

    2011-01-01

    Full Text Available Treatment of malaria in HIV-infected individuals receiving antiretroviral therapy (ART poses significant challenges. Artemether-lumefantrine (AL is one of the artemisisnin-based combination therapies recommended for treatment of malaria. The drug combination is highly efficacious against sensitive and multidrug resistant falciparum malaria. Both artemether and lumefantrine are metabolized by hepatic cytochrome P450 (CYP450 enzymes which metabolize the protease inhibitors (PIs and nonnucleoside reverse transcriptase inhibitors (NNRTIs used for HIV treatment. Coadministration of NNRTIs and PIs with AL could potentially cause complex pharmacokinetic drug interactions. NNRTI by inducing CYP450 3A4 enzyme and PIs by inhibiting CYP450 3A4 enzymes could influence both artemether and lumefantrine concentrations and their active metabolites dihydroartemisinin and desbutyl-lumefantrine, predisposing patients to poor treatment response, toxicity, and risk for development of resistance. There are scanty data on these interactions and their consequences. Pharmacokinetic studies to evaluate these interactions in the target populations are urgently needed.

  6. Identification of 1-Aryl-1H-1,2,3-triazoles as Potential New Antiretroviral Agents.

    Science.gov (United States)

    Gonzaga, Daniel T G; Souza, Thiago M L; Andrade, Viviane M M; Ferreira, Vitor F; de C da Silva, Fernando

    2018-01-01

    Low molecular weight 1-Aryl-1H-1,2,3-triazoles are endowed with various types of biological activities, such as against cancer, HIV and bacteria. Despite the existence of six different classes of antiretroviral drugs in clinical use, HIV/AIDS continue to be an on growing public health problem. In the present study, we synthesized and evaluated thirty 1-Aryl-1H-1,2,3-triazoles against HIV replication. The compounds were prepared by Huisgen 1,3-dipolar cycloaddition protocol catalyzed by Cu(I) between aryl azides and propargylic alcohol followed by further esterification and etherification from a nucleophilic substitution with acid chlorides or alkyl bromides in good yields. The compounds were submitted to the inhibition of HIV replication and evaluation of their cytotoxicity. Initially, the compounds were screened at 10 µM and the most active were further evaluated in order to obtain some pharmacological parameters. Thirty molecules were evaluated, six were selected - because they inhibited more than 80% HIV replication. We further showed that two of these compounds are 8-times more potent, and less cytotoxic, than nevirapine, an antiretroviral drug in clinical use. We identified very simple triazoles with promissing antiretroviral activities that led to the development of new drugs against AIDS. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  7. 31 CFR 100.18 - Counterfeit notes to be marked; “redemption” of notes wrongfully so marked.

    Science.gov (United States)

    2010-07-01

    ... moneys, and all officers of national banks, shall stamp or write in plain letters the word “counterfeit... money, which shall be presented at their places of business; and if such officers shall wrongfully stamp...

  8. Pharmacokinetic, Pharmacogenetic, and Other Factors Influencing CNS Penetration of Antiretrovirals

    Directory of Open Access Journals (Sweden)

    Jacinta Nwamaka Nwogu

    2016-01-01

    Full Text Available Neurological complications associated with the human immunodeficiency virus (HIV are a matter of great concern. While antiretroviral (ARV drugs are the cornerstone of HIV treatment and typically produce neurological benefit, some ARV drugs have limited CNS penetration while others have been associated with neurotoxicity. CNS penetration is a function of several factors including sieving role of blood-brain and blood-CSF barriers and activity of innate drug transporters. Other factors are related to pharmacokinetics and pharmacogenetics of the specific ARV agent or mediated by drug interactions, local inflammation, and blood flow. In this review, we provide an overview of the various factors influencing CNS penetration of ARV drugs with an emphasis on those commonly used in sub-Saharan Africa. We also summarize some key associations between ARV drug penetration, CNS efficacy, and neurotoxicity.

  9. In Silico and in Vitro Screening for P-Glycoprotein Interaction with Tenofovir, Darunavir, and Dapivirine: An Antiretroviral Drug Combination for Topical Prevention of Colorectal HIV Transmission.

    Science.gov (United States)

    Swedrowska, Magda; Jamshidi, Shirin; Kumar, Abhinav; Kelly, Charles; Rahman, Khondaker Miraz; Forbes, Ben

    2017-08-07

    The aim of the study was to use in silico and in vitro techniques to evaluate whether a triple formulation of antiretroviral drugs (tenofovir, darunavir, and dapivirine) interacted with P-glycoprotein (P-gp) or exhibited any other permeability-altering drug-drug interactions in the colorectal mucosa. Potential drug interactions with P-gp were screened initially using molecular docking, followed by molecular dynamics simulations to analyze the identified drug-transporter interaction more mechanistically. The transport of tenofovir, darunavir, and dapivirine was investigated in the Caco-2 cell models and colorectal tissue, and their apparent permeability coefficient (P app ), efflux ratio (ER), and the effect of transporter inhibitors were evaluated. In silico, dapivirine and darunavir showed strong affinity for P-gp with similar free energy of binding; dapivirine exhibiting a ΔG PB value -38.24 kcal/mol, darunavir a ΔG PB value -36.84 kcal/mol. The rank order of permeability of the compounds in vitro was tenofovir dapivirine. The P app for tenofovir in Caco-2 cell monolayers was 0.10 ± 0.02 × 10 -6 cm/s, ER = 1. For dapivirine, P app was 32.2 ± 3.7 × 10 -6 cm/s, but the ER = 1.3 was lower than anticipated based on the in silico findings. Neither tenofovir nor dapivirine transport was influenced by P-gp inhibitors. The absorptive permeability of darunavir (P app = 6.4 ± 0.9 × 10 -6 cm/s) was concentration dependent with ER = 6.3, which was reduced by verapamil to 1.2. Administration of the drugs in combination did not alter their permeability compared to administration as single agents. In conclusion, in silico modeling, cell culture, and tissue-based assays showed that tenofovir does not interact with P-gp and is poorly permeable, consistent with a paracellular transport mechanism. In silico modeling predicted that darunavir and dapivirine were P-gp substrates, but only darunavir showed P-gp-dependent permeability in the biological models, illustrating that

  10. AIDS Diarrhea and Antiretroviral Drug Concentrations: A Matched-Pair Cohort Study in Port au Prince, Haiti

    Science.gov (United States)

    Dillingham, Rebecca; Leger, Paul; Beauharnais, Carole-Anne; Miller, Erica; Kashuba, Angela; Jennings, Steven; Dupnik, Kathryn; Samie, Amidou; Eyma, Etna; Guerrant, Richard; Pape, Jean; Fitzgerald, Daniel

    2011-01-01

    Diarrhea in patients with acquired immunodeficiency syndrome (AIDS) may cause malabsorption of medications and failure of antiretroviral therapy (ART). We prospectively evaluated human immunodeficiency virus-1 (HIV-1)-infected patients with and without chronic diarrhea initiating ART in Haiti. We report mean plasma antiretroviral concentrations at 2 and 4 weeks. We measured plasma HIV-1 RNA levels at four points. Fifty-two HIV-1-infected patients (26 matched pairs) were enrolled. No differences in antiretroviral concentrations were detected. At week 24, 18/25 (72%) cases and 16/24 (68%) controls had undetectable plasma HIV-1 RNA levels (P = 0.69). Patients with plasma HIV-1 RNA levels > 50 copies/mL at week 24 had lower early efavirenz concentrations than patients with undetectable HIV-1 RNA (2,621 ng/mL versus 5,278 ng/mL; P = 0.02). Diarrhea at ART initiation does not influence plasma concentrations of the medications evaluated. Virologic outcome at Week 24 does correlate with efavirenz concentrations early in therapy but not with the presence of chronic diarrhea. PMID:21633022

  11. Discrimination of whisky brands and counterfeit identification by UV-Vis spectroscopy and multivariate data analysis.

    Science.gov (United States)

    Martins, Angélica Rocha; Talhavini, Márcio; Vieira, Maurício Leite; Zacca, Jorge Jardim; Braga, Jez Willian Batista

    2017-08-15

    The discrimination of whisky brands and counterfeit identification were performed by UV-Vis spectroscopy combined with partial least squares for discriminant analysis (PLS-DA). In the proposed method all spectra were obtained with no sample preparation. The discrimination models were built with the employment of seven whisky brands: Red Label, Black Label, White Horse, Chivas Regal (12years), Ballantine's Finest, Old Parr and Natu Nobilis. The method was validated with an independent test set of authentic samples belonging to the seven selected brands and another eleven brands not included in the training samples. Furthermore, seventy-three counterfeit samples were also used to validate the method. Results showed correct classification rates for genuine and false samples over 98.6% and 93.1%, respectively, indicating that the method can be helpful for the forensic analysis of whisky samples. Copyright © 2017 Elsevier Ltd. All rights reserved.

  12. Roman sophisticated surface modification methods to manufacture silver counterfeited coins

    Science.gov (United States)

    Ingo, G. M.; Riccucci, C.; Faraldi, F.; Pascucci, M.; Messina, E.; Fierro, G.; Di Carlo, G.

    2017-11-01

    By means of the combined use of X-ray photoelectron spectroscopy (XPS), optical microscopy (OM) and scanning electron microscopy (SEM) coupled with energy dispersive X-ray spectroscopy (EDS) the surface and subsurface chemical and metallurgical features of silver counterfeited Roman Republican coins are investigated to decipher some aspects of the manufacturing methods and to evaluate the technological ability of the Roman metallurgists to produce thin silver coatings. The results demonstrate that over 2000 ago important advances in the technology of thin layer deposition on metal substrates were attained by Romans. The ancient metallurgists produced counterfeited coins by combining sophisticated micro-plating methods and tailored surface chemical modification based on the mercury-silvering process. The results reveal that Romans were able systematically to chemically and metallurgically manipulate alloys at a micro scale to produce adherent precious metal layers with a uniform thickness up to few micrometers. The results converge to reveal that the production of forgeries was aimed firstly to save expensive metals as much as possible allowing profitable large-scale production at a lower cost. The driving forces could have been a lack of precious metals, an unexpected need to circulate coins for trade and/or a combinations of social, political and economic factors that requested a change in money supply. Finally, some information on corrosion products have been achieved useful to select materials and methods for the conservation of these important witnesses of technology and economy.

  13. Tenofovir-based regimens associated with less drug resistance in HIV-1-infected Nigerians failing first-line antiretroviral therapy.

    Science.gov (United States)

    Etiebet, Mary-Ann A; Shepherd, James; Nowak, Rebecca G; Charurat, Man; Chang, Harry; Ajayi, Samuel; Elegba, Olufunmilayo; Ndembi, Nicaise; Abimiku, Alashle; Carr, Jean K; Eyzaguirre, Lindsay M; Blattner, William A

    2013-02-20

    In resource-limited settings, HIV-1 drug resistance testing to guide antiretroviral therapy (ART) selection is unavailable. We retrospectively conducted genotypic analysis on archived samples from Nigerian patients who received targeted viral load testing to confirm treatment failure and report their drug resistance mutation patterns. Stored plasma from 349 adult patients on non-nucleoside reverse transcriptase inhibitor (NNRTI) regimens was assayed for HIV-1 RNA viral load, and samples with more than 1000 copies/ml were sequenced in the pol gene. Analysis for resistance mutations utilized the IAS-US 2011 Drug Resistance Mutation list. One hundred and seventy-five samples were genotyped; the majority of the subtypes were G (42.9%) and CRF02_AG (33.7%). Patients were on ART for a median of 27 months. 90% had the M184V/I mutation, 62% had at least one thymidine analog mutation, and 14% had the K65R mutation. 97% had an NNRTI resistance mutation and 47% had at least two etravirine-associated mutations. In multivariate analysis tenofovir-based regimens were less likely to have at least three nucleoside reverse transcriptase inhibitor (NRTI) mutations after adjusting for subtype, previous ART, CD4, and HIV viral load [P < 0.001, odds ratio (OR) 0.04]. 70% of patients on tenofovir-based regimens had at least two susceptible NRTIs to include in a second-line regimen compared with 40% on zidovudine-based regimens (P = 0.04, OR = 3.4). At recognition of treatment failure, patients on tenofovir-based first-line regimens had fewer NRTI drug-resistant mutations and more active NRTI drugs available for second-line regimens. These findings can inform strategies for ART regimen sequencing to optimize long-term HIV treatment outcomes in low-resource settings.

  14. When to start antiretroviral therapy and what to start with - A european perspective

    NARCIS (Netherlands)

    Wit, Ferdinand W. N. M.; Reiss, Peter

    2003-01-01

    Although antiretroviral combination therapy has greatly improved the life expectancy of HIV-infected individuals, its use is hampered by considerable toxicity, the need for life-long near-perfect adherence to strict dosing regimens in order to avoid the emergence of drug resistance, and high cost.

  15. Magnetic resonance imaging of folic acid-coated magnetite nanoparticles reflects tissue biodistribution of long-acting antiretroviral therapy

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    Li T

    2015-06-01

    Full Text Available Tianyuzi Li,1 Howard E Gendelman,1,2 Gang Zhang,1 Pavan Puligujja,1 JoEllyn M McMillan,1 Tatiana K Bronich,2 Benson Edagwa,1 Xin-Ming Liu,1,2 Michael D Boska3 1Department of Pharmacology and Experimental Neuroscience, 2Department of Pharmaceutical Sciences, 3Department of Radiology, University of Nebraska Medical Center, Omaha, NE, USA Abstract: Regimen adherence, systemic toxicities, and limited drug penetrance to viral reservoirs are obstacles limiting the effectiveness of antiretroviral therapy (ART. Our laboratory’s development of the monocyte-macrophage-targeted long-acting nanoformulated ART (nanoART carriage provides a novel opportunity to simplify drug-dosing regimens. Progress has nonetheless been slowed by cumbersome, but required, pharmacokinetic (PK, pharmacodynamics, and biodistribution testing. To this end, we developed a small magnetite ART (SMART nanoparticle platform to assess antiretroviral drug tissue biodistribution and PK using magnetic resonance imaging (MRI scans. Herein, we have taken this technique a significant step further by determining nanoART PK with folic acid (FA decorated magnetite (ultrasmall superparamagnetic iron oxide [USPIO] particles and by using SMART particles. FA nanoparticles enhanced the entry and particle retention to the reticuloendothelial system over nondecorated polymers after systemic administration into mice. These data were seen by MRI testing and validated by comparison with SMART particles and direct evaluation of tissue drug levels after nanoART. The development of alendronate (ALN-coated magnetite thus serves as a rapid initial screen for the ability of targeting ligands to enhance nanoparticle-antiretroviral drug biodistribution, underscoring the value of decorated magnetite particles as a theranostic tool for improved drug delivery. Keywords: folic acid, decorated nanoparticles, magnetite, theranostics, magnetic resonance imaging

  16. Social, Cultural, and Environmental Challenges Faced by Children on Antiretroviral Therapy in Zimbabwe: a Mixed-Method Study

    Science.gov (United States)

    Macherera, Margaret; Moyo, Lindani; Ncube, Mkhanyiseli; Gumbi, Angella

    2012-01-01

    Objectives Despite the advent of antiretroviral therapy (ART), many children, particularly in the rural communities of Zimbabwe, remain vulnerable. The purpose of this study was to determine the factors and challenges facing children on antiretroviral therapy (ART) in Brunapeg area of Mangwe District, Zimbabwe. Methods A mixed-method approach involving interviewer-guided focus group discussions and piloted semi-structured questionnaires was utilized to collect data from different key population groups. The data obtained were analyzed through content coding procedures based on a set of predetermined themes of interest. Results A number of challenges emerged as barriers to the success of antiretroviral therapy for children. Primary care givers were less informed about HIV and AIDS issues for people having direct impact on the success of antiretroviral therapy in children whilst some were found to be taking the antiretroviral drugs meant for the children. It also emerged that some primary care givers were either too young or too old to care for the children while others had failed to disclose to the children why they frequently visited the Opportunistic Infections (OI) clinic. Most primary care givers were not the biological parents of the affected children. Other challenges included inadequate access to health services, inadequate food and nutrition and lack of access to clean water, good hygiene and sanitation. The lack of community support and stigma and discrimination affected their school attendance and hospital visits. All these factors contributed to non-adherence to antiretroviral drugs. Conclusions and Public Health Implications Children on ART in rural communities in Zimbabwe remain severely compromised and have unique problems that need multi-intervention strategies both at policy and programmatic levels. Effective mitigating measures must be fully established and implemented in rural communities of developing countries in the fight for universal

  17. Social, Cultural, and Environmental Challenges Faced by Children on Antiretroviral Therapy in Zimbabwe: a Mixed Method Study

    Directory of Open Access Journals (Sweden)

    Margaret Macherera, MSc

    2012-11-01

    Full Text Available Objectives:Despite the advent of antiretroviral therapy (ART, many children, particularly in the rural communities of Zimbabwe, remain vulnerable. The purpose of this study was to determine the factors and challenges facing children on antiretroviral therapy (ART in Brunapeg area of Mangwe District, Zimbabwe.Methods:A mixed-method approach involving interviewer-guided focus group discussions and piloted semi-structured questionnaires was utilized to collect data from different key population groups. The data obtained were analyzed through content coding procedures based on a set of predetermined themes of interest.Results:A number of challenges emerged as barriers to the success of antiretroviral therapy for children. Primary care givers were less informed about HIV and AIDS issues for people having direct impact on the success of antiretroviral therapy in children whilst some were found to be taking the antiretroviral drugs meant for the children. It also emerged that some primary care givers were either too young or too old to care for the children while others had failed to disclose to the children why they frequently visited the Opportunistic Infections (OI clinic. Most primary care givers were not the biological parents of the affected children. Other challenges included inadequate access to health services, inadequate food and nutrition and lack of access to clean water, good hygiene and sanitation. The lack of community support and stigma and discrimination affected their school attendance and hospital visits. All these factors contributed to non-adherence to antiretroviral drugs.Conclusions and Public Health Implications:Children on ART in rural communities in Zimbabwe remain severely compromised and have unique problems that need multi-intervention strategies both at policy and programmatic levels. Effective mitigating measures must be fully established and implemented in rural communities of developing countries in the fight for

  18. The Demand for Antiretroviral Drugs in the Illicit Marketplace: Implications for HIV Disease Management Among Vulnerable Populations.

    Science.gov (United States)

    Tsuyuki, Kiyomi; Surratt, Hilary L; Levi-Minzi, Maria A; O'Grady, Catherine L; Kurtz, Steven P

    2015-05-01

    The diversion of antiretroviral medications (ARVs) has implications for the integrity and success of HIV care, however little is known about the ARV illicit market. This paper aimed to identify the motivations for buying illicit ARVs and to describe market dynamics. Semi-structured interviews (n = 44) were conducted with substance-involved individuals living with HIV who have a history of purchasing ARVs on the street. Grounded theory was used to code and analyze interviews. Motivations for buying ARVs on the illicit market were: to repurchase ARVs after having diverted them for money or drugs; having limited access or low quality health care; to replace lost or ruined ARVs; and to buy a back-up stock of ARVs. This study identified various structural barriers to HIV treatment and ARV adherence that incentivized ARV diversion. Findings highlight the need to improve patient-provider relationships, ensure continuity of care, and integrate services to engage and retain high-needs populations.

  19. Antiretroviral Resistance and Pregnancy Characteristics of Women with Perinatal and Nonperinatal HIV Infection.

    Science.gov (United States)

    Lazenby, Gweneth B; Mmeje, Okeoma; Fisher, Barbra M; Weinberg, Adriana; Aaron, Erika K; Keating, Maria; Luque, Amneris E; Willers, Denise; Cohan, Deborah; Money, Deborah

    2016-01-01

    Objective. To compare HIV drug resistance in pregnant women with perinatal HIV (PHIV) and those with nonperinatal HIV (NPHIV) infection. Methods. We conducted a multisite cohort study of PHIV and NPHIV women from 2000 to 2014. Sample size was calculated to identify a fourfold increase in antiretroviral (ARV) drug resistance in PHIV women. Continuous variables were compared using Student's t-test and Wilcoxon rank-sum tests. Categorical variables were compared using χ (2) and Fisher's exact tests. Univariate analysis was used to determine factors associated with antiretroviral drug resistance. Results. Forty-one PHIV and 41 NPHIV participants were included. Women with PHIV were more likely to have drug resistance than those with NPHIV ((55% versus 17%, p = 0.03), OR 6.0 (95% CI 1.0-34.8), p = 0.05), including multiclass resistance (15% versus 0, p = 0.03), and they were more likely to receive nonstandard ARVs during pregnancy (27% versus 5%, p = 0.01). PHIV and NPHIV women had similar rates of preterm birth (11% versus 28%, p = 0.08) and cesarean delivery (47% versus 46%, p = 0.9). Two infants born to a single NPHIV woman acquired HIV infection. Conclusions. PHIV women have a high frequency of HIV drug resistance mutations, leading to nonstandard ARVs use during pregnancy. Despite nonstandard ARV use during pregnancy, PHIV women did not experience increased rates of adverse pregnancy outcomes.

  20. Through-container, extremely low concentration detection of multiple chemical markers of counterfeit alcohol using a handheld SORS device.

    Science.gov (United States)

    Ellis, David I; Eccles, Rebecca; Xu, Yun; Griffen, Julia; Muhamadali, Howbeer; Matousek, Pavel; Goodall, Ian; Goodacre, Royston

    2017-09-21

    Major food adulteration incidents occur with alarming frequency and are episodic, with the latest incident, involving the adulteration of meat from 21 producers in Brazil supplied to 60 other countries, reinforcing this view. Food fraud and counterfeiting involves all types of foods, feed, beverages, and packaging, with the potential for serious health, as well as significant economic and social impacts. In the spirit drinks sector, counterfeiters often 'recycle' used genuine packaging, or employ good quality simulants. To prove that suspect products are non-authentic ideally requires accurate, sensitive, analysis of the complex chemical composition while still in its packaging. This has yet to be achieved. Here, we have developed handheld spatially offset Raman spectroscopy (SORS) for the first time in a food or beverage product, and demonstrate the potential for rapid in situ through-container analysis; achieving unequivocal detection of multiple chemical markers known for their use in the adulteration and counterfeiting of Scotch whisky, and other spirit drinks. We demonstrate that it is possible to detect a total of 10 denaturants/additives in extremely low concentrations without any contact with the sample; discriminate between and within multiple well-known Scotch whisky brands, and detect methanol concentrations well below the maximum human tolerable level.

  1. Activity of antiretroviral drugs in human infections by opportunistic agents

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    Izabel Galhardo Demarchi

    2012-03-01

    Full Text Available Highly active antiretroviral therapy (HAART is used in patients infected with HIV. This treatment has been shown to significantly decrease opportunist infections such as those caused by viruses, fungi and particularly, protozoa. The use of HAART in HIV-positive persons is associated with immune reconstitution as well as decreased prevalence of oral candidiasis and candidal carriage. Antiretroviral therapy benefits patients who are co-infected by the human immunodeficiency virus (HIV, human herpes virus 8 (HHV-8, Epstein-Barr virus, hepatitis B virus (HBV, parvovirus B19 and cytomegalovirus (CMV. HAART has also led to a significant reduction in the incidence, and the modification of characteristics, of bacteremia by etiological agents such as Staphylococcus aureus, coagulase negative staphylococcus, non-typhoid species of Salmonella, Streptococcus pneumoniae, Pseudomonas aeruginosa, and Mycobacterium tuberculosis. HAART can modify the natural history of cryptosporidiosis and microsporidiosis, and restore mucosal immunity, leading to the eradication of Cryptosporidium parvum. A similar restoration of immune response occurs in infections by Toxoplasma gondii. The decline in the incidence of visceral leishmaniasis/HIV co-infection can be observed after the introduction of protease inhibitor therapy. Current findings are highly relevant for clinical medicine and may serve to reduce the number of prescribed drugs thereby improving the quality of life of patients with opportunistic diseases.A terapia HAART (terapia antirretroviral altamente ativa é usada em pacientes infectados pelo vírus da imunodeficiência humana (HIV e demonstrou diminuição significativa de infecções oportunistas, tais como as causadas por vírus, fungos, protozoários e bactérias. O uso da HAART está associado com a reconstituição imunológica e diminuição na prevalência de candidíase oral. A terapia antirretroviral beneficia pacientes co-infectados pelo HIV, v

  2. Adherence to antiretroviral therapy and its determinants in AIDS patients: review article

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    Hajiabdolbaghi M

    2008-10-01

    known to overestimate adherence. Some determinants are associated with adherence include: age, gender, addiction specially injection drug users, alcohol consumption, depression, social support, level of education, work situation, adverse antiretroviral effects, pregnancy, type of antiretroviral drug regimen, number of pills and daily doses received, severe traumas, social and psychological factors, and relationship between clinician and patient.0 "nKeywords: Adherence, antiretroviral therapy, AIDS, treatment.

  3. Prevalence of possible drug-drug interactions between antiretroviral agents in different age groups in a section of the private health care sector setting in South Africa.

    Science.gov (United States)

    Katende-Kyenda, N L; Lubbe, M S; Serfontein, J H P; Truter, I

    2008-08-01

    The chronic nature of human immunodeficiency virus (HIV) infection requires lifelong highly active antiretroviral (ARV) therapy (HAART) to continuously suppress HIV-1 viral replication, thus reducing morbidity and mortality. HAART is restricted by complex dosing, drug-drug interactions (DDIs) and toxicities. To determine the prevalence of possible DDIs between ARV drugs in different age groups in a section of the private primary health care sector in South Africa. A quantitative, retrospective drug utilization review was performed on 47 085 ARV prescriptions claimed through a national medicine claims database during 2006. Possible DDIs identified were classified according to a clinical significance rating as described by Tatro [Drug Interaction Facts 2005. St Louis, MO: Facts and Comparisons (2005)]. The total number of patients who received prescriptions that were claimed through the medicine claims database was 275 424, of whom 25.11% were males, 28.28% were females and the gender of 46.61% patients was unknown. Of the total number of patients, 3.27% were HIV patients of which an average of 5.23 +/- 3.86 ARV prescriptions (n = 47 085) per patient were claimed for representing 4.73% of the total number of prescriptions claimed during the study period (N = 993 804). HIV patients received an average of 2.36 +/- 0.61 ARVs per prescription. Only 4.95% of the prescriptions had one ARV medicine item, 56.04% two, 37.10% three, 1.75% four and 6 years and 12 and 60 years with patients <40 years and < or =60 years having the highest number of DDIs and patients older than 60 years the lowest. The majority of DDIs between the ARVs presented in significance levels 2 and 4. The most important interactions were between: indinavir (IDV) and ritonavir (n = 199); efavirenz (EFV) and lopinavir/ritonavir (n = 65) and EFV and IDV (n = 60) all interacting at level 2. The importance of using drug utilization study as an identification tool to provide insight into the prescribing and

  4. Counterfeit and their museums: observation of the aesthetic categories of the pirate consumption

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    Eneus Trindade Barreto

    2013-09-01

    Full Text Available This paper arises from discussions about consumption and piracy,analyzing the role of counterfeit museums, and their paradoxes in the way they communicating the ambivalences of meaning e types of commercial piracy; based on Lipovetsky’s thought (2004; 2007, the articles illustrates the debate about consumption and piracy with 3 museum cases in Thailand, Italy and France.

  5. Dose-to-dose variations with single packages of counterfeit medicines and adulterated dietary supplements as a potential source of false negatives and inaccurate health risk assessments.

    Science.gov (United States)

    Venhuis, B J; Zwaagstra, M E; Keizers, P H J; de Kaste, D

    2014-02-01

    In this report, we show three examples of how the variability in dose units in single packages of counterfeit medicines and adulterated dietary supplements may contribute to a false negative screening result and inaccurate health risk assessments. We describe a counterfeit Viagra 100mg blister pack and a box of an instant coffee both containing dose units with and without an active pharmaceutical ingredient (API). We also describe a purportedly herbal slimming product with capsules that mutually differed in API and impurities. The adulterated dietary supplements contained sibutramine, benzyl-sibutramine, N-desmethyl-sibutramine (DMS), N,N-didesmethyl-sibutramine (DDMS) and several other related impurities. Counterfeit medicines and adulterated dietary supplements are a health risk because their quality is unreliable. Health risks are even greater when such unreliability extends to fundamental differences between dose units in one package. Because dose-to-dose variability for these products is unpredictable, the confidence interval of a sample size is unknown. Consequently, the analyses of a selection of dose units may not be representative for the package. In the worst case, counterfeit or unauthorised medicines are not recognised as such or a health risk is not identified. In order to reduce erroneous results particular care should be taken when analysing a composite of dose units, when finding no API in a dietary supplement and when finding conformity in a suspect counterfeit medicine. Copyright © 2013 Elsevier B.V. All rights reserved.

  6. Manifestações otoneurológicas associadas à terapia anti-retroviral Otoneurological manifestations associated with antiretroviral therapy

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    Andrêza Batista Cheloni Vieira

    2008-02-01

    Full Text Available Ototoxicidade e terapia anti-retroviral parecem estar associadas. O objetivo desse estudo foi avaliar essa possível correlação. Foram avaliados 779 prontuários médicos de pacientes infectados pelo HIV e regularmente acompanhados, sendo 162 tratados com terapia anti-retroviral e 122 não tratados (controle. Pacientes em tratamento eram mais velhos (média 42 anos, com maior tempo de confirmação sorológica (80 meses e com menor carga viral (p=0,00. CD4+ foi semelhante entre os grupos (P=0,60. No grupo tratado, três (1,8% casos de perda auditiva idiopática e dois (1,3% de perda auditiva relacionada a otosclerose foram observadas e ambas iniciadas após terapia anti-retroviral. Nenhuma diferença estatística relacionada à perda auditiva idiopática foi encontrada entre os grupos. Enquanto estudos descritivos consideram possível ototoxidade associada à terapia anti-retroviral, esse possível efeito adverso não foi relacionado à terapia anti-retroviral neste estudo. Contrariamente, otosclerose poderia estar correlacionada à terapia anti-retroviral. Este assunto merece ser estudado.Ototoxicity and antiretroviral therapy seem to be associated. The aim of this study was to evaluate this possible correlation. Evaluations were carried out on 779 medical records from HIV-infected patients who were being regularly followed up, of whom 162 were being treated with antiretroviral therapy and 122 were untreated (controls. The patients undergoing treatment were older (mean: 42 years, had had serological confirmation for longer times (80 months and had smaller viral loads (P = 0.00. CD4+ was similar between the groups (P = 0.60. In the treated group, three cases (1.8% of idiopathic hearing loss and two (1.3% of otosclerosis-related hearing loss were observed, which both started after antiretroviral therapy. No statistical difference relating to idiopathic hearing loss was found between the groups. While descriptive studies consider possible

  7. [Antiretroviral drug supply in Argentina: National Program to Combat Human Retroviruses, AIDS, and STDs].

    Science.gov (United States)

    Colautti, Marisel; Luppi, Irene; Salamano, Mercedes; Traverso, María Luz; Botta, Carina; Palchik, Valeria

    2009-01-01

    To evaluate the supply cycle of antiretroviral (ARV) drugs, overseen by the National Program to Combat Human Retroviruses, AIDS, and STDs, through its order fulfillment indicators, and to obtain input from supply chain stakeholders. A study was carried out from April-September 2005 in the pharmacies of two hospitals in Rosario, Argentina, involving both a quantitative analysis of indicators and secondary sources and a qualitative evaluation using semistructured interviews. The indicators reveal the impact that interruptions in ARV supply stream from the Program (central level) have and the overstocking that takes place at the pharmacies (local level) to manage the shortages. Changes in ARV treatment account for over 50% of the prescriptions. Fulfillments fall short of the reference value. The interviewees shared possible strategies for overcoming the communication gaps between levels, for building-up stock, for guaranteeing availability, and for shortening waiting times; reached informal agreements to deal with the lack of policies and the shortage of staff; acknowledged the challenges facing the jurisdictions (central, intermediate, and local/community); and recognized local efforts to improve management. These challenges could be the starting point for building teams to work on effectively decentralizing the entire supply chain and allowing the Program to fulfill its much-needed oversight role.

  8. [High activity antiretroviral therapy change associated to adverse drug reactions in a specialized center in Venezuela].

    Science.gov (United States)

    Subiela, José D; Dapena, Elida

    2016-03-01

    Adverse drug reactions (ADRs) represent the first cause of change of the first-line highly active antiretroviral therapy (HAART) regimen, therefore, they constitute the main limiting factor in the long-term follow up of HIV patients in treatment. A retrospective study was carried out in a specialized center in Lara State, Venezuela, including 99 patients over 18 years of age who had change of first-line HAART regimen due to ADRs, between 2010 and 2013. The aims of this research were to describe the sociodemographic and clinical variables, frequency of ADRs related to change of HAART, duration of the first-line HAART regimen, to determine the drugs associated with ARVs and to identify the risk factors. The ADRs constituted 47.5% of all causes of change of first-line HAART regimen, the median duration was 1.08±0.28 years. The most frequent ADRs were anemia (34.3%), hypersensitivity reactions (20.2%) and gastrointestinal intolerance (13.1%). The most frequent ARV regimen type was the protease inhibitors-based regimen (59.6%), but zidovudine was the ARV most linked to ADRs (41.4%). The regression analysis showed increased risk of ADRs in singles and students in the univariate analysis and heterosexuals and homosexuals in multivariate analysis; and decreased risk in active workers. The present work shows the high prevalence of ADRs in the studied population and represents the first case-based study that describes the pharmacoepidemiology of a cohort of HIV-positive patients treated in Venezuela.

  9. COUNTERFEITING ROMAN COINS IN THE ROMAN EMPIRE I – III A.D. STUDY ON THE ROMAN PROVINCES OF DACIA AND PANNONIA

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    Razvan Bogdan Gaspar

    2015-12-01

    Full Text Available This paper is based on the study of Roman silver coins, from archaeological sites located in Roman Dacia and Pannonia. Initially centred on the record of hybrid silver coins, the paper expanded its analysis on counterfeit pieces as well in order to fully understand all problems of roman silver coinage from the 1stto the 3rd centuries AD.The new and larger area of research had more than one implications, coin distribution on the studied sites, influx of coin in the province, quantity of recorded counterfeited pieces being just some of them. Thus every situation was discussed in different chapters, first presenting the coins and the laws that protected them, the studied sites and the analyse of the silver coins on these sites, the general and compared situation between the provinces, interpretation of the counterfeited and hybrid pieces and finally, conclusions on the subject.All these tasks have been achieved one step at a time, each archaeological site providing precious data which piled up and was finally pressed in order to present the correct historical situation.

  10. Acute Liver Failure among Patients on Efavirenz-Based Antiretroviral Therapy

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    Innocent Lule Segamwenge

    2018-01-01

    Full Text Available Objectives. To describe the clinical characteristics of patients presenting with fulminant liver failure after varying periods of exposure to Efavirenz containing antiretroviral medications. Methods. We report a series of 4 patients with human immunodeficiency virus (HIV infection who were admitted with acute liver failure (ALF over a 6-month period. All these patients had been treated with a range of Efavirenz containing antiretroviral regimens and were negative for hepatitis A, B, and C infections as well as other opportunistic infections, all were negative for autoimmune hepatitis, and none had evidence of chronic liver disease or use of alcohol or herbal medications. Information on patient clinical characteristics, current antiretroviral regimen, CD4 count, HIV-1 RNA levels, and clinical chemistry parameters was collected. Informed consent was provided. Results. During a 6-month period, four patients without other known risk factors for acute hepatitis presented with symptomatic drug-induced liver injury with varying symptoms and outcomes. The pattern of liver injury was hepatocellular for all the 4 cases. Liver biopsies were done for all the four cases and the results showed a heavy mixed inflammatory cell infiltrate with eosinophils. For three patients withdrawal of Efavirenz from their antiretroviral regimen was sufficient to restore transaminase levels to normal and led to improvement of clinical symptoms. For one patient his clinical course was characterized by fulminant liver failure and fluctuating episodes of hepatic encephalopathy which ultimately resulted in his death. Conclusion. Hepatotoxicity of Efavirenz is not as rare as previously described in the literature and does actually present with fatal outcomes. The key message to note is that frequent monitoring of liver enzymes should be done at initiation of antiretroviral therapy and should continue throughout the treatment period.

  11. Screen-printed nanoparticles as anti-counterfeiting tags

    Science.gov (United States)

    Campos-Cuerva, Carlos; Zieba, Maciej; Sebastian, Victor; Martínez, Gema; Sese, Javier; Irusta, Silvia; Contamina, Vicente; Arruebo, Manuel; Santamaria, Jesus

    2016-03-01

    Metallic nanoparticles with different physical properties have been screen printed as authentication tags on different types of paper. Gold and silver nanoparticles show unique optical signatures, including sharp emission bandwidths and long lifetimes of the printed label, even under accelerated weathering conditions. Magnetic nanoparticles show distinct physical signals that depend on the size of the nanoparticle itself. They were also screen printed on different substrates and their magnetic signals read out using a magnetic pattern recognition sensor and a vibrating sample magnetometer. The novelty of our work lies in the demonstration that the combination of nanomaterials with optical and magnetic properties on the same printed support is possible, and the resulting combined signals can be used to obtain a user-configurable label, providing a high degree of security in anti-counterfeiting applications using simple commercially-available sensors.

  12. Guidelines for using antiretroviral agents among HIV-infected adults and adolescents. Recommendations of the Panel on Clinical Practices for Treatment of HIV.

    Science.gov (United States)

    Dybul, Mark; Fauci, Anthony S; Bartlett, John G; Kaplan, Jonathan E; Pau, Alice K

    2002-05-17

    The availability of an increasing number of antiretroviral agents and the rapid evolution of new information has introduced substantial complexity into treatment regimens for persons infected with human immunodeficiency virus (HIV). In 1996, the Department of Health and Human Services and the Henry J. Kaiser Family Foundation convened the Panel on Clinical Practices for the Treatment of HIV to develop guidelines for clinical management of HIV-infected adults and adolescents (CDC. Report of the NIH Panel To Define Principles of Therapy of HIV Infection and Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. MMWR 1998;47[RR-5]:1-41). This report, which updates the 1998 guidelines, addresses 1) using testing for plasma HIV ribonucleic acid levels (i.e., viral load) and CD4+ T cell count; 2) using testing for antiretroviral drug resistance; 3) considerations for when to initiate therapy; 4) adherence to antiretroviral therapy; 5) considerations for therapy among patients with advanced disease; 6) therapy-related adverse events; 7) interruption of therapy; 8) considerations for changing therapy and available therapeutic options; 9) treatment for acute HIV infection; 10) considerations for antiretroviral therapy among adolescents; 11) considerations for antiretroviral therapy among pregnant women; and 12) concerns related to transmission of HIV to others. Antiretroviral regimens are complex, have serious side effects, pose difficulty with adherence, and carry serious potential consequences from the development of viral resistance because of nonadherence to the drug regimen or suboptimal levels of antiretroviral agents. Patient education and involvement in therapeutic decisions is critical. Treatment should usually be offered to all patients with symptoms ascribed to HIV infection. Recommendations for offering antiretroviral therapy among asymptomatic patients require analysis of real and potential risks and benefits. Treatment should

  13. "Every drug goes to treat its own disease…" - a qualitative study of perceptions and experiences of taking anti-retrovirals concomitantly with anti-malarials among those affected by HIV and malaria in Tanzania

    DEFF Research Database (Denmark)

    Mangesho, Peter E; Reynolds, Joanna; Lemnge, Martha

    2014-01-01

    BACKGROUND: Little is known about how people living with human immunodeficiency virus (HIV) experience malaria and the concomitant use of anti-malarial treatments with anti-retrovirals (ARVs). An understanding of how patients make sense of these experiences is important to consider in planning......, perceptions of drug strength appeared to compel some people not enrolled in the clinical study to take the drugs at separate times to avoid anticipated harm to the body. CONCLUSIONS: Management of HIV and malaria concurrently often requires individuals to cross the domains of different disease programmes...

  14. The temperature-sensitive luminescence of (Y,Gd)VO{sub 4}:Bi{sup 3+},Eu{sup 3+} and its application for stealth anti-counterfeiting

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Lei; Zhang, Yao; Luo, Anqi; Liu, Fayong; Jiang, Yang; Hu, Qingzhuo [School of Materials Science and Engineering, Hefei University of Technology (China); Chen, Shifu [Department of Chemistry, Huaibei Normal University (China); Liu, Ru-Shi [Department of Chemistry, National Taiwan University, Taipei (China)

    2012-07-15

    Anti-counterfeiting technologies are desired to protect products far away from the violation of dummy, fake and shoddy goods. The phosphor of (Y,Gd)VO{sub 4}:Bi{sup 3+},Eu{sup 3+} was synthesized for the application of this purpose. Its photoluminescence was investigated by exciting with different wavelengths at variant temperatures. Wide emission color ranged from green through yellow to orange was tuned up by tailor-ing Bi{sup 3+} and Eu{sup 3+} concentrations. The temperature dependent luminescence and wavelength selective excitation of (Y,Gd)VO{sub 4}:Bi{sup 3+},Eu{sup 3+} were observed, which provide different encryptions in anti-counterfeiting. To verify the feasibility in application, two anti-counterfeiting patterns were fabricated practically and excellent performance was obtained. Moreover, the physical mechanisms for the different phenomena of luminescence were elucidated from excitation spectra combining with the configuration coordinate model. (copyright 2012 WILEY-VCH Verlag GmbH and Co. KGaA, Weinheim) (orig.)

  15. Transmitted antiretroviral drug resistance in New York State, 2006-2008: results from a new surveillance system.

    Directory of Open Access Journals (Sweden)

    Adam C Readhead

    Full Text Available HIV transmitted drug resistance (TDR is a public health concern because it has the potential to compromise antiretroviral therapy (ART at the population level. In New York State, high prevalence of TDR in a local cohort and a multiclass resistant case cluster led to the development and implementation of a statewide resistance surveillance system.We conducted a cross-sectional analysis of the 13,109 cases of HIV infection that were newly diagnosed and reported in New York State between 2006 and 2008, including 4,155 with HIV genotypes drawn within 3 months of initial diagnosis and electronically reported to the new resistance surveillance system. We assessed compliance with DHHS recommendations for genotypic resistance testing and estimated TDR among new HIV diagnoses.Of 13,109 new HIV diagnoses, 9,785 (75% had laboratory evidence of utilization of HIV-related medical care, and 4,155 (43% had a genotype performed within 3 months of initial diagnosis. Of these, 11.2% (95% confidence interval [CI], 10.2%-12.1% had any evidence of TDR. The proportion with mutations associated with any antiretroviral agent in the NNRTI, NRTI or PI class was 6.3% (5.5%-7.0%, 4.3% (3.6%-4.9% and 2.9% (2.4%-3.4%, respectively. Multiclass resistance was observed in <1%. TDR did not increase significantly over time (p for trend = 0.204. Men who have sex with men were not more likely to have TDR than persons with heterosexual risk factor (OR 1.0 (0.77-1.30. TDR to EFV+TDF+FTC and LPV/r+TDF+FTC regimens was 7.1% (6.3%-7.9% and 1.4% (1.0%-1.8%, respectively.TDR appears to be evenly distributed and stable among new HIV diagnoses in New York State; multiclass TDR is rare. Less than half of new diagnoses initiating care received a genotype per DHHS guidelines.

  16. Antiretroviral chemoprophylaxis in children and adolescents victims of rape in Abidjan.

    Science.gov (United States)

    Ehui, E; Couitchéré, L S; Kouakou, G A; Doumbia, A; Kassi, A N; Mossou, C M; Guié, P Y; Eholié, S

    2015-08-01

    We described the use of antiretroviral drugs to prevent HIV transmission among children and adolescents victims of rape in Abidjan (Ivory Coast). We conducted a retrospective and descriptive study on children (0-9 years) and adolescents (10-19 years) victims of rape between 2000 and 2013. We analyzed the patients' socio-demographic characteristics and the modality of the chemoprophylaxis. We included 10 children and 89 adolescents in the study. The median age was 16 years old (3-19 years). The median time to consultation was 23.5 hours (5-152 hours). The antiretroviral chemoprophylaxis was administered to 92 patients (93%). No HIV and HBV seroconversion was observed after a 3-month follow-up. A better management of rape victims is required in Abidjan. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  17. Patent Pooling for Promoting Access to Antiretroviral Drugs (ARVs) - A Strategic Option for India.

    Science.gov (United States)

    Satyanarayana, Kanikaram; Srivastava, Sadhana

    2010-01-19

    The current HIV/AIDS scenario in India is quite grim with an estimated 2.4 million people living with HIV/AIDS (PLHA) in 2008, just behind South Africa and Nigeria. The anti-retroviral drugs (ARVs) remain the main stay of global HIV/AIDS treatment. Over 30 ARVs (single and FDCs) available under six categories viz., NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), Protease inhibitors, the new Fusion inhibitors, Entry inhibitors-CCR5 co-receptor antagonists and HIV integrase strand transfer inhibitors. The major originator companies for these ARVs are: Abbott, Boehringer Ingelheim (BI), Bristol-Myers Squibb (BMS), Gilead, GlaxoSmithKline (GSK), Merck, Pfizer, Roche, and Tibotec. Beginning with zidovidine in 1987, all the drugs are available in the developed countries. In India, about 30 ARVs are available as generics manufactured by Aurobindo, Hyderabad, Andhra Pradesh; Cipla Limited, Goa; Emcure Pharmaceuticals, Pune, Maharashtra; Hetero Drugs, Hyderabad, Andhra Pradesh; Macleods Pharmaceuticals, Daman; Matrix Laboratories, Nashik, Maharashtra; Ranbaxy, Sirmour, Himachal Pradesh; and Strides Arcolab, Bangalore, Karnataka. The National AIDS Control Organization (NACO) set up in 1992 by the Govt. of India provides free ARVs to HIV positive patients in India since 2004. The drugs available in India include both single drugs and FDCs covering both first line and second line ARVs. Even while there are claims of stabilization of the disease load, there is still huge gap of those who require ARVs as only about 150,000 PLHA receive the ARVs from the Govt. and other sources. Access to ARVs therefore is still a cause of serious concern ever since India became fully Trade Related Aspects of Intellectual Property Rights (TRIPS)-complaint in 2005. Therefore, the Indian pharmaceutical companies cannot make generics for those for drugs introduced post-2005 due to product patent regime. Other concerns include heat stable

  18. ADHERENCE TO ANTIRETROVIRAL THERAPY IN A TERTIARY CARE HOSPITAL

    Directory of Open Access Journals (Sweden)

    Muralidhara Panigrahi

    2017-03-01

    Full Text Available BACKGROUND The Million Death Study Collaborators in the British Medical Journal have estimated that the people living with HIV/AIDS population to be between 1.4-1.6 million. Development of Antiretroviral Therapy (ART has been one of the dramatic advances in the history of medicine. Among several factors that can affect the ART outcome, adherence to the ART has been cited as a major factor associated with poor outcomes. For ART to have maximum effect greater than 95%, adherence has been suggested. Additionally, non adherence to ART is a major cause of HIV drug resistance. Especially, in the Indian context, adherence to ART is very important due to the sheer number of HIV/AIDS cases, the socioeconomic status, diversity of the population and regions. That is, the socioeconomic challenges faced by patients contribute to nonadherence to ART in India. With this background, this study was done with the primary objective of assessing the level of adherence to the given regimen of ART as per the NACO guidelines and factors influencing adherence. MATERIALS AND METHODS This is a prospective patient record-based study conducted in the Antiretroviral Therapy Centre at MKCG Medical College, Berhampur, from January 2016 to June 2016. Simple random sampling technique was used to select 150 patients’ records from the ART Centre of the medical college. The data was collected in a predesigned case record form from the patient card available at antiretroviral therapy centre. The patients were followed up through the patient card for six months from their recruitment. The adherence to treatment was evaluated using the adherence score adopted by NACO where a score of 1, 2 and 3 implied that 95%, 80-95% and 95% medication taken. Persons with primary education, married individuals and persons without employment had better improvement in adherence score than other groups. Anaemia was the predominant adverse drug reaction encountered. CONCLUSION The findings of this

  19. Antiretroviral Resistance and Pregnancy Characteristics of Women with Perinatal and Nonperinatal HIV Infection

    Directory of Open Access Journals (Sweden)

    Gweneth B. Lazenby

    2016-01-01

    Full Text Available Objective. To compare HIV drug resistance in pregnant women with perinatal HIV (PHIV and those with nonperinatal HIV (NPHIV infection. Methods. We conducted a multisite cohort study of PHIV and NPHIV women from 2000 to 2014. Sample size was calculated to identify a fourfold increase in antiretroviral (ARV drug resistance in PHIV women. Continuous variables were compared using Student’s t-test and Wilcoxon rank-sum tests. Categorical variables were compared using χ2 and Fisher’s exact tests. Univariate analysis was used to determine factors associated with antiretroviral drug resistance. Results. Forty-one PHIV and 41 NPHIV participants were included. Women with PHIV were more likely to have drug resistance than those with NPHIV ((55% versus 17%, p=0.03, OR 6.0 (95% CI 1.0–34.8, p=0.05, including multiclass resistance (15% versus 0, p=0.03, and they were more likely to receive nonstandard ARVs during pregnancy (27% versus 5%, p=0.01. PHIV and NPHIV women had similar rates of preterm birth (11% versus 28%, p=0.08 and cesarean delivery (47% versus 46%, p=0.9. Two infants born to a single NPHIV woman acquired HIV infection. Conclusions. PHIV women have a high frequency of HIV drug resistance mutations, leading to nonstandard ARVs use during pregnancy. Despite nonstandard ARV use during pregnancy, PHIV women did not experience increased rates of adverse pregnancy outcomes.

  20. Regional changes over time in initial virological response rates to combination antiretroviral therapy across Europe

    DEFF Research Database (Denmark)

    Bannister, W; Kirk, O; Gatell, J

    2006-01-01

    BACKGROUND: Changes in virologic response to initial combination antiretroviral therapy (cART) over calendar time may indicate improvements in cART or emergence of primary resistance. Regional variations may identify differences in available antiretroviral drugs or patient management. METHODS.......026) and time (P changes were observed (south, P = 0.061; central west, P ....001; north: P = 0.070; east, P = 0.001). CONCLUSIONS: There was some evidence of regional differences in initial virologic response to cART. Improvements over time were observed, suggesting that so far, the effect of primary resistance has not been of sufficient magnitude to prevent increasing suppression...

  1. Antiretroviral therapy for adults infected with HIV: Guidelines for health care professionals from the Quebec HIV care committee.

    Science.gov (United States)

    Rouleau, Danielle; Fortin, Claude; Trottier, Benoît; Lalonde, Richard; Lapointe, Normand; Côté, Pierre; Routy, Jean-Pierre; Matte, Marie-France; Tsarevsky, Irina; Baril, Jean-Guy

    2011-01-01

    The appropriate use of antiretrovirals reduces morbidity and mortality caused by HIV infection. The present article provides health care professionals with a practical guide for the use of antiretrovirals. Therapy should be initiated based predominantly on clinical presentation and CD4 count, and should consist of three active drugs or at least two active drugs when this is not possible, as in cases of some treatment-experienced patients. This is the most effective way to achieve long-term suppression of viral replication. Selection of individual drugs in the regimen should consider the weight of the evidence supporting these choices, as well as their tolerability profiles and ease of use, the patients' comorbidities and treatment history. Treatment interruption is not recommended, either in aviremic patients or in those who have experienced virological failure. Instead, the therapeutic regimen should be adjusted to minimize side effects, promote adherence and suppress viral replication.

  2. Antiretroviral therapy for adults infected with HIV: Guidelines for health care professionals from the Quebec HIV care committee

    Science.gov (United States)

    Rouleau, Danielle; Fortin, Claude; Trottier, Benoît; Lalonde, Richard; Lapointe, Normand; Côté, Pierre; Routy, Jean-Pierre; Matte, Marie-France; Tsarevsky, Irina; Baril, Jean-Guy

    2011-01-01

    The appropriate use of antiretrovirals reduces morbidity and mortality caused by HIV infection. The present article provides health care professionals with a practical guide for the use of antiretrovirals. Therapy should be initiated based predominantly on clinical presentation and CD4 count, and should consist of three active drugs or at least two active drugs when this is not possible, as in cases of some treatment-experienced patients. This is the most effective way to achieve long-term suppression of viral replication. Selection of individual drugs in the regimen should consider the weight of the evidence supporting these choices, as well as their tolerability profiles and ease of use, the patients’ comorbidities and treatment history. Treatment interruption is not recommended, either in aviremic patients or in those who have experienced virological failure. Instead, the therapeutic regimen should be adjusted to minimize side effects, promote adherence and suppress viral replication. PMID:22654926

  3. Therapeutic drug monitoring of atazanavir/ritonavir in pregnancy.

    LENUS (Irish Health Repository)

    Else, L J

    2014-11-01

    Pregnant women experience physiological changes during pregnancy that can have a significant impact on antiretroviral pharmacokinetics. Ensuring optimal plasma concentrations of antiretrovirals is essential for maternal health and to minimize the risk of vertical transmission. Here we describe atazanavir\\/ritonavir (ATV\\/r) plasma concentrations in a cohort of pregnant women undergoing routine therapeutic drug monitoring (TDM).

  4. Differences in Lipid Measurements by Antiretroviral Regimen Exposure in Cohorts from Asia and Australia

    Directory of Open Access Journals (Sweden)

    Amit C. Achhra

    2012-01-01

    Full Text Available We explored the mean differences in routinely measured lipids (total cholesterol, triglycerides, and high-density lipoprotein cholesterol according to exposure to different combination antiretroviral regimens in Asian (n=2051 and Australian (predominantly Caucasian, n=794 cohorts. The regimen was defined as at least 3 antiretroviral drugs with at least 2 nucleoside-reverse transcriptases (NRTIs and either of at least one protease inhibitor (PI or non-nucleoside-reverse transcriptases (NNRTIs. We categorised cART regimens as: NRTIs as tenofovir based or not; NNRTIs as nevirapine or efavirenz (but not both; and PI as atazanavir based or not. We found that the impact of various antiretroviral regimens on lipids in Asian and Australian cohorts was only different by cohort for total cholesterol (P for interaction between regimen and cohort: 0.05. The differences in total cholesterol were however small and unlikely to be of clinical significance. Overall, tenofovir with nevirapine or atazanavir was associated with the most favorable lipids, while the PI regimens without tenofovir and atazanavir were associated with least favorable lipids. We conclude that the impact of various ART regimens on lipids is largely similar in Asian and Australian cohorts and that the newer drugs such as tenofovir and atazanavir are likely to provide similar benefit in terms of lipid profiles in both populations.

  5. A Script Analysis of the Distribution of Counterfeit Alcohol Across Two European Jurisdictions

    OpenAIRE

    Lord, Nicholas; Spencer, Jonathan; Bellotti, Elisa; Benson, Katie

    2017-01-01

    This article presents a script analysis of the distribution of counterfeit alcohols across two European jurisdictions. Based on an analysis of case file data from a European regulator and interviews with investigators, the article deconstructs the organisation of the distribution of the alcohol across jurisdictions into five scenes (collection, logistics, delivery, disposal, proceeds/finance) and analyses the actual (or likely permutations of) behaviours within each scene. The analysis also i...

  6. Caenorhabditis elegans as a Model System for Studying Drug Induced Mitochondrial Toxicity.

    Directory of Open Access Journals (Sweden)

    Richard de Boer

    Full Text Available Today HIV-1 infection is recognized as a chronic disease with obligatory lifelong treatment to keep viral titers below detectable levels. The continuous intake of antiretroviral drugs however, leads to severe and even life-threatening side effects, supposedly by the deleterious impact of nucleoside-analogue type compounds on the functioning of the mitochondrial DNA polymerase. For detailed investigation of the yet partially understood underlying mechanisms, the availability of a versatile model system is crucial. We therefore set out to develop the use of Caenorhabditis elegans to study drug induced mitochondrial toxicity. Using a combination of molecular-biological and functional assays, combined with a quantitative analysis of mitochondrial network morphology, we conclude that anti-retroviral drugs with similar working mechanisms can be classified into distinct groups based on their effects on mitochondrial morphology and biochemistry. Additionally we show that mitochondrial toxicity of antiretroviral drugs cannot be exclusively attributed to interference with the mitochondrial DNA polymerase.

  7. Budget impact analysis of antiretroviral less drug regimen simplification in HIV-positive patients on the Italian National Health Service

    Directory of Open Access Journals (Sweden)

    Restelli U

    2014-09-01

    Full Text Available Umberto Restelli,1,2 Massimo Andreoni,3 Andrea Antinori,4 Marzia Bonfanti,2 Giovanni Di Perri,5 Massimo Galli,6 Adriano Lazzarin,7 Giuliano Rizzardini,8,9 Davide Croce1,2 1Department of Community Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 2Centro di Ricerca in Economia e Management in Sanità e nel Sociale (CREMS, Università Carlo Cattaneo – LIUC, Castellanza (VA, Italy; 3Clinical Infectious Diseases, Tor Vergata University (PTV, Rome, Italy; 4Clinical Department, National Institute for Infectious Diseases "L. Spallanzani," Rome, Italy; 5Department of Medical Sciences, Infectious Diseases, Amedeo di Savoia Hospital, Turin, Italy; 6Third Division of Infectious Diseases, "Luigi Sacco" Hospital, Milan, Italy; 7Department of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy; 8First and Second Divisions of Infectious Diseases, "Luigi Sacco" Hospital, Milan, Italy; 9School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Background: Deintensification and less drug regimen (LDR antiretroviral therapy (ART strategies have proved to be effective in terms of maintaining viral suppression in human immunodeficiency virus (HIV-positive patients, increasing tolerability, and reducing toxicity of antiretroviral drugs administered to patients. However, the economic impact of these strategies have not been widely investigated. The aim of the study is to evaluate the economic impact that ART LDR could have on the Italian National Health Service (INHS budget. Methods: A budget impact model was structured to assess the potential savings for the INHS by the use of ART LDR for HIV-positive patients with a 3 year perspective. Data concerning ART cost, patient distribution within different ARTs, and probabilities for patients to change ART on a yearly basis were collected within four Italian infectious diseases departments, providing

  8. LC-MS/MS determination of antiretroviral drugs in influents and effluents from wastewater treatment plants in KwaZulu-Natal, South Africa.

    Science.gov (United States)

    Abafe, Ovokeroye A; Späth, Jana; Fick, Jerker; Jansson, Stina; Buckley, Chris; Stark, Annegret; Pietruschka, Bjoern; Martincigh, Bice S

    2018-06-01

    South Africa has the largest occurrence of the human immune deficiency virus (HIV) in the world but has also implemented the largest antiretroviral (ARV) treatment programme. It was therefore of interest to determine the presence and concentrations of commonly used antiretroviral drugs (ARVDs) and, also, to determine the capabilities of wastewater treatment plants (WWTPs) for removing ARVDs. To this end, a surrogate standard based LC-MS/MS method was optimized and applied for the detection of thirteen ARVDs used in the treatment and management of HIV/acquired immune deficiency syndrome (HIV/AIDS) in two major and one modular WWTP in the eThekwini Municipality in KwaZulu-Natal, South Africa. The method was validated and the detection limits fell within the range of 2-20 ng L -1 . The analytical recoveries for the ARVDs were mainly greater than 50% with acceptable relative standard deviations. The concentration values ranged from effluent) in a decentralized wastewater treatment facility (DEWATS); effluent) in Northern WWTP and 61-34000 ng L -1 (influent), effluent) in Phoenix WWTP. Whilst abacavir, lamivudine and zidovudine were almost completely removed from the effluents, atazanavir, efavirenz, lopinavir and nevirapine persisted in the effluents from all three WWTPs. To estimate the ecotoxicological risks associated with the discharge of ARVDs, a countrywide survey focussing on the occurrence of ARVDs in WWTPs, surface and fresh water bodies, and aquatic organisms, is necessary. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. The internet trade of counterfeit spirits in Russia – an emerging problem undermining alcohol, public health and youth protection policies? [version 2; referees: 2 approved

    OpenAIRE

    Maria Neufeld; Dirk W. Lachenmeier; Stephan G. Walch; Jürgen Rehm

    2017-01-01

    Counterfeit alcohol belongs to the category of unrecorded alcohol not reflected in official statistics. The internet trade of alcoholic beverages has been prohibited by the Russian Federation since 2007, but various sellers still offer counterfeit spirits (i.e., forged brand spirits) over the internet to Russian consumers, mostly in a non-deceptive fashion at prices up to 15 times lower than in regular sale. The public health issues arising from this unregulated trade include potential harm t...

  10. The internet trade of counterfeit spirits in Russia – an emerging problem undermining alcohol, public health and youth protection policies? [version 1; referees: 2 approved

    OpenAIRE

    Maria Neufeld; Dirk W. Lachenmeier; Stephan G. Walch; Jürgen Rehm

    2017-01-01

    Counterfeit alcohol belongs to the category of unrecorded alcohol not reflected in official statistics. The internet trade of alcoholic beverages has been prohibited by the Russian Federation since 2007, but various sellers still offer counterfeit spirits (i.e., forged brand spirits) over the internet to Russian consumers, mostly in a non-deceptive fashion at prices up to 15 times lower than in regular sale. The public health issues arising from this unregulated trade include potential harm t...

  11. Systemic administration of antiretrovirals prior to exposure prevents rectal and intravenous HIV-1 transmission in humanized BLT mice.

    Directory of Open Access Journals (Sweden)

    Paul W Denton

    2010-01-01

    Full Text Available Successful antiretroviral pre-exposure prophylaxis (PrEP for mucosal and intravenous HIV-1 transmission could reduce new infections among targeted high-risk populations including discordant couples, injection drug users, high-risk women and men who have sex with men. Targeted antiretroviral PrEP could be particularly effective at slowing the spread of HIV-1 if a single antiretroviral combination were found to be broadly protective across multiple routes of transmission. Therefore, we designed our in vivo preclinical study to systematically investigate whether rectal and intravenous HIV-1 transmission can be blocked by antiretrovirals administered systemically prior to HIV-1 exposure. We performed these studies using a highly relevant in vivo model of mucosal HIV-1 transmission, humanized Bone marrow/Liver/Thymus mice (BLT. BLT mice are susceptible to HIV-1 infection via three major physiological routes of viral transmission: vaginal, rectal and intravenous. Our results show that BLT mice given systemic antiretroviral PrEP are efficiently protected from HIV-1 infection regardless of the route of exposure. Specifically, systemic antiretroviral PrEP with emtricitabine and tenofovir disoproxil fumarate prevented both rectal (Chi square = 8.6, df = 1, p = 0.003 and intravenous (Chi square = 13, df = 1, p = 0.0003 HIV-1 transmission. Our results indicate that antiretroviral PrEP has the potential to be broadly effective at preventing new rectal or intravenous HIV transmissions in targeted high risk individuals. These in vivo preclinical findings provide strong experimental evidence supporting the potential clinical implementation of antiretroviral based pre-exposure prophylactic measures to prevent the spread of HIV/AIDS.

  12. The novel approach to enhance seed security: dual anti-counterfeiting methods applied on tobacco pelleted seeds.

    Science.gov (United States)

    Guan, Yajing; Wang, Jianchen; Tian, Yixin; Hu, Weimin; Zhu, Liwei; Zhu, Shuijin; Hu, Jin

    2013-01-01

    Seed security is of prime importance for agriculture. To protect true seeds from being faked, more secure dual anti-counterfeiting technologies for tobacco (Nicotiana tabacum L.) pelleted seed were developed in this paper. Fluorescein (FR), rhodamine B (RB), and magnetic powder (MP) were used as anti-counterfeiting labels. According to their different properties and the special seed pelleting process, four dual-labeling treatments were conducted for two tobacco varieties, MS Yunyan85 (MSYY85) and Honghua Dajinyuan (HHDJY). Then the seed germination and seedling growth status were investigated, and the fluorescence in cracked pellets and developing seedlings was observed under different excitation lights. The results showed that FR, RB, and MP had no negative effects on the germination, seedling growth, and MDA content of the pelleted seeds, and even some treatments significantly enhanced seedling dry weight, vigor index, and shoot height in MS YY85, and increased SOD activity and chlorophyll content in HHDJY as compared to the control. In addition, the cotyledon tip of seedlings treated with FR and MP together represented bright green fluorescence under illumination of blue light (478 nm). And the seedling cotyledon vein treated with RB and MP together showed red fluorescence under green light (546 nm). All seeds pelleted with magnetic powder of proper concentration could be attracted by a magnet. Thus, it indicated that those new dual-labeling methods that fluorescent compound and magnetic powder simultaneously applied in the same seed pellets definitely improved anti-counterfeiting technology and enhanced the seed security. This technology will ensure that high quality seed will be used in the crop production.

  13. The novel approach to enhance seed security: dual anti-counterfeiting methods applied on tobacco pelleted seeds.

    Directory of Open Access Journals (Sweden)

    Yajing Guan

    Full Text Available Seed security is of prime importance for agriculture. To protect true seeds from being faked, more secure dual anti-counterfeiting technologies for tobacco (Nicotiana tabacum L. pelleted seed were developed in this paper. Fluorescein (FR, rhodamine B (RB, and magnetic powder (MP were used as anti-counterfeiting labels. According to their different properties and the special seed pelleting process, four dual-labeling treatments were conducted for two tobacco varieties, MS Yunyan85 (MSYY85 and Honghua Dajinyuan (HHDJY. Then the seed germination and seedling growth status were investigated, and the fluorescence in cracked pellets and developing seedlings was observed under different excitation lights. The results showed that FR, RB, and MP had no negative effects on the germination, seedling growth, and MDA content of the pelleted seeds, and even some treatments significantly enhanced seedling dry weight, vigor index, and shoot height in MS YY85, and increased SOD activity and chlorophyll content in HHDJY as compared to the control. In addition, the cotyledon tip of seedlings treated with FR and MP together represented bright green fluorescence under illumination of blue light (478 nm. And the seedling cotyledon vein treated with RB and MP together showed red fluorescence under green light (546 nm. All seeds pelleted with magnetic powder of proper concentration could be attracted by a magnet. Thus, it indicated that those new dual-labeling methods that fluorescent compound and magnetic powder simultaneously applied in the same seed pellets definitely improved anti-counterfeiting technology and enhanced the seed security. This technology will ensure that high quality seed will be used in the crop production.

  14. New and investigational antiretroviral drugs for HIV infection: mechanisms of action and early research findings.

    Science.gov (United States)

    Saag, Michael S

    2012-12-01

    Numerous investigational antiretroviral agents are in clinical development. Among them are festinavir (BMS986001), a thymidine analogue similar to stavudine with reduced potential for toxicity; GS-7340, a prodrug of tenofovir that achieves greater intracellular concentrations; MK-1439, a nonnucleoside analogue reverse transcriptase inhibitor (NNRTI) that retains activity against common NNRTI-associated resistance mutations; and albuvirtide, a long-acting parenteral fusion inhibitor. Investigational integrase strand transfer inhibitors (InSTIs) include elvitegravir, recently approved by the US Food and Drug Administration (FDA) as part of a once-daily, single-tablet formulation with cobicistat/tenofovir/emtricitabine; dolutegravir, which maintains some activity against raltegravir- and elvitegravir-resistant mutants; and S/GSK1265744, which also maintains some activity against resistance mutations in the integrase gene and is being developed as a long-lasting parenteral agent. Novel 2-(quinolin-3-yl)acetic acid derivatives (LEDGINs), agents that were originally thought to inhibit the interaction of integrase with its cofactor lens epithelium-derived growth factor p75 (LEDGF/p75), be active against InSTI-resistant mutants and to have additive activity when combined with InSTIs. This article summarizes a presentation by Michael S. Saag, MD, at the IAS-USA live Improving the Management of HCV Disease continuing medical education program held in New York in October 2012.

  15. Rationale and uses of a public HIV drug-resistance database.

    Science.gov (United States)

    Shafer, Robert W

    2006-09-15

    Knowledge regarding the drug resistance of human immunodeficiency virus (HIV) is critical for surveillance of drug resistance, development of antiretroviral drugs, and management of infections with drug-resistant viruses. Such knowledge is derived from studies that correlate genetic variation in the targets of therapy with the antiretroviral treatments received by persons from whom the variant was obtained (genotype-treatment), with drug-susceptibility data on genetic variants (genotype-phenotype), and with virological and clinical response to a new treatment regimen (genotype-outcome). An HIV drug-resistance database is required to represent, store, and analyze the diverse forms of data underlying our knowledge of drug resistance and to make these data available to the broad community of researchers studying drug resistance in HIV and clinicians using HIV drug-resistance tests. Such genotype-treatment, genotype-phenotype, and genotype-outcome correlations are contained in the Stanford HIV RT and Protease Sequence Database and have specific usefulness.

  16. Antiretroviral therapy for adults infected with HIV: Guidelines for health care professionals from the Quebec HIV care committee

    Directory of Open Access Journals (Sweden)

    Danielle Rouleau

    2011-01-01

    Full Text Available The appropriate use of antiretrovirals reduces morbidity and mortality caused by HIV infection. The present article provides health care professionals with a practical guide for the use of antiretrovirals. Therapy should be initiated based predominantly on clinical presentation and CD4 count, and should consist of three active drugs or at least two active drugs when this is not possible, as in cases of some treatment-experienced patients. This is the most effective way to achieve long-term suppression of viral replication. Selection of individual drugs in the regimen should consider the weight of the evidence supporting these choices, as well as their tolerability profiles and ease of use, the patients’ comorbidities and treatment history. Treatment interruption is not recommended, either in aviremic patients or in those who have experienced virological failure. Instead, the therapeutic regimen should be adjusted to minimize side effects, promote adherence and suppress viral replication.

  17. Hospitalization due to Adverse Drug Reactions and Drug Interactions before and after HAART

    Directory of Open Access Journals (Sweden)

    Michelle M Foisy

    2000-01-01

    Full Text Available OBJECTIVE: To characterize and compare the rates of adverse drug reactions (ADRs and interactions on admission in two, one-year periods: pre-highly active antiretroviral therapy (HAART (phase 1 and post-HAART (phase 2.

  18. HIV-1 evolution, drug resistance, and host genetics: The Indian scenario

    Directory of Open Access Journals (Sweden)

    U Shankarkumar

    2009-03-01

    Full Text Available U Shankarkumar, A Pawar, K GhoshNational Institute of Immunohaematology (ICMR, KEM Hospital, Parel, Mumbai, Maharashtra, IndiaAbstract: A regimen with varied side effects and compliance is of paramount importance to prevent viral drug resistance. Most of the drug-resistance studies, as well as interpretation algorithms, are based on sequence data from HIV-1 subtype B viruses. Increased resistance to antiretroviral drugs leads to poor prognosis by restricting treatment options. Due to suboptimal adherence to antiretroviral therapy there is an emergence of drug-resistant HIV-1 strains. The other factors responsible for this viral evolution are antiretroviral drug types and host genetics, especially major histocompatibility complex (MHC. Both primary and secondary drug resistances occur due to mutations in specific epitopes of viral protein regions which may influence the T cell recognition by immune system through MHC Class I and class II alleles. Mutations in viral epitopes enable the virus to escape the immune system. New drugs under clinical trials are being added but their exorbitant costs limit their access in developing countries. Thus the environmental consequences and, the impact of both viral and host genetic variations on the therapy in persons infected with HIV-1 clade C from India need to be determined.Keywords: HIV-1 C drug resistance, virus adaptation, HARRT, India

  19. Control of Suspect/Counterfeit and Defective Items

    Energy Technology Data Exchange (ETDEWEB)

    Sheriff, Marnelle L.

    2013-09-03

    This procedure implements portions of the requirements of MSC-MP-599, Quality Assurance Program Description. It establishes the Mission Support Alliance (MSA) practices for minimizing the introduction of and identifying, documenting, dispositioning, reporting, controlling, and disposing of suspect/counterfeit and defective items (S/CIs). employees whose work scope relates to Safety Systems (i.e., Safety Class [SC] or Safety Significant [SS] items), non-safety systems and other applications (i.e., General Service [GS]) where engineering has determined that their use could result in a potential safety hazard. MSA implements an effective Quality Assurance (QA) Program providing a comprehensive network of controls and verification providing defense-in-depth by preventing the introduction of S/CIs through the design, procurement, construction, operation, maintenance, and modification of processes. This procedure focuses on those safety systems, and other systems, including critical load paths of lifting equipment, where the introduction of S/CIs would have the greatest potential for creating unsafe conditions.

  20. Prevalence and effect of pre-treatment drug resistance on the virological response to antiretroviral treatment initiated in HIV-infected children - a EuroCoord-CHAIN-EPPICC joint project

    DEFF Research Database (Denmark)

    Ngo-Giang-Huong, Nicole; Wittkop, Linda; Judd, Ali

    2016-01-01

    BACKGROUND: Few studies have evaluated the impact of pre-treatment drug resistance (PDR) on response to combination antiretroviral treatment (cART) in children. The objective of this joint EuroCoord-CHAIN-EPPICC/PENTA project was to assess the prevalence of PDR mutations and their association...... algorithm to infer resistance to prescribed drugs. Time to virological failure (VF) was defined as the first of two consecutive HIV-RNA > 500 copies/mL after 6 months cART and was assessed by Cox proportional hazards models. All models were adjusted for baseline demographic, clinical, immunology.......7-5.7). Of 37 children (7.8 %, 95 % confidence interval (CI), 5.5-10.6) harboring a virus with ≥1 PDR mutations, 30 children had a virus resistant to ≥1 of the prescribed drugs. Overall, the cumulative Kaplan-Meier estimate for virological failure was 19.8 % (95 %CI, 16.4-23.9). Cumulative risk for VF tended...

  1. Determinants of durability of first-line antiretroviral therapy regimen and time from first-line failure to second-line antiretroviral therapy initiation

    DEFF Research Database (Denmark)

    Desmonde, Sophie; Eboua, François T; Malateste, Karen

    2015-01-01

    BACKGROUND: We described reasons for switching to second-line antiretroviral treatment (ART) and time to switch in HIV-infected children failing first-line ART in West Africa. METHODS: We included all children aged 15 years or less, starting ART (at least three drugs) in the paediatric Ie...... post-ART initiation, 188 (7%) had switched to second-line. The most frequent reasons were drug stock outs (20%), toxicity (18%), treatment failure (16%) and poor adherence (8%). Over the 24-month follow-up period, 322 (12%) children failed first-line ART after a median time of 7 months...... rare and switches after an immunological failure were insufficient. These gaps reveal that it is crucial to advocate for both sustainable access to first-line and alternative regimens to provide adequate roll-out of paediatric ART programmes....

  2. Antiretroviral Drug Activity in Macaques Infected during Pre-Exposure Prophylaxis Has a Transient Effect on Cell-Associated SHIV DNA Reservoirs.

    Directory of Open Access Journals (Sweden)

    Mian-Er Cong

    Full Text Available Pre-exposure prophylaxis (PrEP with emtricitabine and tenofovir disoproxil fumarate (FTC/TDF is a novel HIV prevention strategy. Suboptimal PrEP adherence and HIV infection creates an opportunity for continued antiretroviral drug activity during undiagnosed infection. We previously showed that macaques infected with SHIV during PrEP with FTC/TDF display reduced acute plasma viremias and limited virus diversity. We investigated the effect of PrEP on acute SHIV DNA dynamics and on the size of the persistent virus reservoir in lymphoid tissues.Cell-associated SHIV DNA levels in PBMCs were measured in 8 macaques infected during PrEP with FTC/TDF or single-agent TAF and was compared to those seen in untreated infections (n = 10. PrEP breakthrough infections continued treatment with 1-2 weekly drug doses to model suboptimal drug exposure during undiagnosed HIV infection in humans. SHIV DNA was also measured in lymphoid tissues collected from FTC/TDF PrEP breakthroughs after 1 year of infection.Compared to untreated controls, PrEP infections had reduced plasma RNA viremias both at peak and throughout weeks 1-12 (p<0.005. SHIV DNA levels were also reduced at peak and during the first 12 weeks of infection (p<0.043 but not throughout weeks 12-20. At 1 year, SHIV DNA reservoirs in lymphoid tissues were similar in size among macaques that received PrEP or placebo.Antiviral drug activity due to PrEP limits acute SHIV replication but has only a transient effect on cell-associated SHIV DNA levels. Our model suggests that suboptimal drug exposure in persons that are taking PrEP and become infected with HIV may not be sufficient to reduce the pool of HIV-infected cells, and that treatment intensification may be needed to sustain potential virological benefits from the PrEP regimen.

  3. Triple Active Antiretroviral Regimen Including Enfuvirtide Via the Biojector is Effective and Safe

    Directory of Open Access Journals (Sweden)

    Mona Loutfy

    2007-01-01

    Full Text Available For full HIV virological suppression, three fully active antiretroviral agents are required. New drug classes should be included to ensure that agents are fully active. The addition of enfuvirtide and efavirenz to the present patient’s new antiretroviral regimen ensured that two fully active agents were in use in the setting of a moderate degree of nucleoside resistance and a high level of protease resistance, and where non-nucleoside reverse transcriptase inhibitors were still fully active. Both viral load and CD4 count responded favourably to this regimen. The patient received support from physicians and clinic staff in the introduction and use of enfuvirtide. To reduce injection site reactions, a needle-free injection system (Biojector proved effective.

  4. HIV genotype resistance testing in antiretroviral (ART) exposed Indian children--a need of the hour.

    Science.gov (United States)

    Shah, Ira; Parikh, Shefali

    2013-04-01

    Development of drug resistance in HIV infected children with treatment failure is a major impediment to selection of appropriate therapy. HIV genotype resistance assays predict drug resistance on the basis of mutations in the viral genome. However, their clinical utility, especially in a resource limited setting is still a subject of debate. The authors report two cases in which both the children suffered from treatment failure of various antiretroviral therapy regimes. In both the cases, Genotype Resistance Testing (GRT) prompted a radical change from proposed failure therapy as per existing guidelines. GRT was specifically important for the selection of a new dual Nucleoside reverse transcriptase inhibitors (NRTI) component of failure regimen by identifying TAMS and M184V mutations in the HIV genome. These case reports highlight the importance of GRT in children failing multiple antiretroviral regimes; and emphasizes the need to recognize situations where GRT is absolutely essential to guide appropriate therapy, even in a resource limited setting.

  5. Relationship between hunger, adherence to antiretroviral therapy and plasma HIV RNA suppression among HIV-positive illicit drug users in a Canadian setting.

    Science.gov (United States)

    Anema, Aranka; Kerr, Thomas; Milloy, M-J; Feng, Cindy; Montaner, Julio S G; Wood, Evan

    2014-04-01

    Food insecurity may be a barrier to achieving optimal HIV treatment-related outcomes among illicit drug users. This study therefore, aimed to assess the impact of severe food insecurity, or hunger, on plasma HIV RNA suppression among illicit drug users receiving antiretroviral therapy (ART). A cross-sectional Multivariate logistic regression model was used to assess the potential relationship between hunger and plasma HIV RNA suppression. A sample of n = 406 adults was derived from a community-recruited open prospective cohort of HIV-positive illicit drug users, in Vancouver, British Columbia (BC), Canada. A total of 235 (63.7%) reported "being hungry and unable to afford enough food," and 241 (59.4%) had plasma HIV RNA hunger was associated with lower odds of plasma HIV RNA suppression (Odds Ratio = 0.59, 95% confidence interval [CI]: 0.39-0.90, p = 0.015). In multivariate analyses, this association was no longer significant after controlling for socio-demographic, behavioral, and clinical characteristics, including 95% adherence (Adjusted Odds Ratio [AOR] = 0.65, 95% CI: 0.37-1.10, p = 0.105). Multivariate models stratified by 95% adherence found that the direction and magnitude of this association was not significantly altered by the adherence level. Hunger was common among illicit drug users in this setting. Although, there was an association between hunger and lower likelihood of plasma HIV RNA suppression, this did not persist in adjusted analyses. Further research is warranted to understand the social-structural, policy, and physical factors shaping the HIV outcomes of illicit drug users.

  6. Impact of injecting drug use on mortality in Danish HIV-infected patients: a nation-wide population-based cohort study

    DEFF Research Database (Denmark)

    Larsen, Mette V; Omland, Lars H; Gerstoft, Jan

    2010-01-01

    To estimate the impact of injecting drug use (IDU) on mortality in HIV-infected patients in the highly active antiretroviral therapy (HAART) era.......To estimate the impact of injecting drug use (IDU) on mortality in HIV-infected patients in the highly active antiretroviral therapy (HAART) era....

  7. Growth of Scytalidium sp. in a counterfeit bevacizumab bottle

    Directory of Open Access Journals (Sweden)

    Gerardo Garcia-Aguirre

    2013-01-01

    Full Text Available After drawing a dose from an closed bevacizumab (Avastin bottle, a fungus-like foreign body was observed inside. Samples from the vial were cultured in Sabouraud Emmons media. Growth of multiple light brown colonies with dark pigment was observed after 10 days. The species was identified as Scytalidium sp.Vial, analysis reported that the seal was lacking proper identification measures and that the label, batch number and expiry date did not correspond to a genuine product. Chemical analysis showed no protein, but 3% of polyethylene glycol, citrate and ethanol. Counterfeit bevacizumab is a real situation that poses a significant risk for ophthalmology and oncology patients. The medical community should be aware of this situation in order to enforce adequate preventive measures.

  8. Antiretroviral changes during the first year of therapy

    Directory of Open Access Journals (Sweden)

    Antonio Carlos Policarpo Carmo Sá Bandeira

    Full Text Available Summary Introduction: The Brazilian HIV/AIDS management and treatment guideline (PCDT, published in 2013, recommends and standardizes the use of highly active antiretroviral therapy (HAART in all adult patients, in spite of LTCD4 count. This study aimed to analyze the first year of HAART use in patients from a reference center on HIV/AIDS management in Fortaleza, Ceará. Method: This descriptive study reviewed all prescription forms of antiretroviral regimens initiation and changes from January to July 2014. All antiretroviral regimen changes that occurred during the first year of therapy were evaluated. Data were analyzed with SPSS version 20. Mean, standard deviation and frequency, Student’s t and Mann-Whitney tests calculations were used, with significance at p<0.05. Results: From 527 patients initiating HAART, 16.5% (n=87 had a regimen change in the first year. These patients were mostly male (59.8%; n=52, aged 20 to 39 years, with only one HAART change (72.4%; n=63. Efavirenz was the most often changed drug, followed by tenofovir, zidovudine and lopinavir/ritonavir. Mean time of HAART changes was 120 days, with adverse reactions as the most prevalent cause. HAART was effective in decreasing viral load since second month of treatment (p=0.003 and increasing LTCD4 lymphocytes since fifth month (p<0.001. Conclusion: The main cause of initial HAART changes was adverse reaction and most patients had only one change in the HAART regimen. HAART prescription was in accordance to the PCDT from 2013.

  9. In vivo mitochondrial function in HIV-infected persons treated with contemporary anti-retroviral therapy: a magnetic resonance spectroscopy study.

    Directory of Open Access Journals (Sweden)

    Brendan A I Payne

    Full Text Available Modern anti-retroviral therapy is highly effective at suppressing viral replication and restoring immune function in HIV-infected persons. However, such individuals show reduced physiological performance and increased frailty compared with age-matched uninfected persons. Contemporary anti-retroviral therapy is thought to be largely free from neuromuscular complications, whereas several anti-retroviral drugs previously in common usage have been associated with mitochondrial toxicity. It has recently been established that patients with prior exposure to such drugs exhibit irreversible cellular and molecular mitochondrial defects. However the functional significance of such damage remains unknown. Here we use phosphorus magnetic resonance spectroscopy ((31P-MRS to measure in vivo muscle mitochondrial oxidative function, in patients treated with contemporary anti-retroviral therapy, and compare with biopsy findings (cytochrome c oxidase (COX histochemistry. We show that dynamic oxidative function (post-exertional ATP (adenosine triphosphate resynthesis was largely maintained in the face of mild to moderate COX defects (affecting up to ∼10% of fibers: τ½ ADP (half-life of adenosine diphosphate clearance, HIV-infected 22.1±9.9 s, HIV-uninfected 18.8±4.4 s, p = 0.09. In contrast, HIV-infected patients had a significant derangement of resting state ATP metabolism compared with controls: ADP/ATP ratio, HIV-infected 1.24±0.08×10(-3, HIV-uninfected 1.16±0.05×10(-3, p = 0.001. These observations are broadly reassuring in that they suggest that in vivo mitochondrial function in patients on contemporary anti-retroviral therapy is largely maintained at the whole organ level, despite histochemical (COX defects within individual cells. Basal energy requirements may nevertheless be increased.

  10. Association Between the Occurrence of Adverse Drug Events and Modification of First-Line Highly Active Antiretroviral Therapy in Ghanaian HIV Patients.

    Science.gov (United States)

    Tetteh, Raymond A; Nartey, Edmund T; Lartey, Margaret; Mantel-Teeuwisse, Aukje K; Leufkens, Hubert G M; Yankey, Barbara A; Dodoo, Alexander N O

    2016-11-01

    Patients initiated on highly active antiretroviral therapy (HAART) generally remain on medication indefinitely. A modification in the HAART regimen may become necessary because of possible acute or chronic toxicities, concomitant clinical conditions, development of virological failure or the advent of adverse drug events. The study documents adverse drug events of HIV-positive Ghanaian patients with HAART modifications. It also investigates the association between documented adverse drug events and HAART modification using an unmatched case-control study design. The study was conducted in the Fevers Unit of the Korle Bu Teaching Hospital and involved patients who attended the HIV Care Clinic between January 2004 and December 2009. Data from 298 modified therapy patients (cases) were compared with 298 continuing therapy patients (controls) who had been on treatment for at least 1 month before the end of study. Controls were sampled from the same database of a cohort of HIV-positive patients on HAART, at the time a case occurred, in terms of treatment initiation ±1 month. Data were obtained from patients' clinical folders and the HIV clinic database linked to the pharmacy database. The nature of the documented adverse drug events of the cases was described and the association between the documented adverse drug events and HAART modification was determined by logistic regression with reported odds ratios (ORs) and their 95 % confidence interval (CI). Among the 298 modified therapy patients sampled in this study, 52.7 % of them had at least one documented adverse drug event. The most documented adverse drug event was anaemia, recorded in 18.5 % of modified therapy patients, all of whom were on a zidovudine-based regimen. The presence of documented adverse drug events was significantly associated with HAART modification [adjusted OR = 2.71 (95 % CI 2.11-3.48), p < 0.001]. Among HIV patients on HAART, adverse drug events play a major role in treatment

  11. Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study: a phase-II randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Montoya Carlos J

    2009-06-01

    Full Text Available Abstract Background Highly active antiretroviral therapy produces a significant decrease in HIV-1 replication and allows an increase in the CD4 T-cell count, leading to a decrease in the incidence of opportunistic infections and mortality. However, the cost, side effects and complexity of antiretroviral regimens have underscored the immediate need for additional therapeutic approaches. Statins exert pleiotropic effects through a variety of mechanisms, among which there are several immunoregulatory effects, related and unrelated to their cholesterol-lowering activity that can be useful to control HIV-1 infection. Methods/design Randomized, double-blinded, placebo controlled, single-center, phase-II clinical trial. One hundred and ten chronically HIV-1-infected patients, older than 18 years and naïve for antirretroviral therapy (i.e., without prior or current management with antiretroviral drugs will be enrolled at the outpatient services from the most important centres for health insurance care in Medellin-Colombia. The interventions will be lovastatin (40 mg/day, orally, for 12 months; 55 patients or placebo (55 patients. Our primary aim will be to determine the effect of lovastatin on viral replication. The secondary aim will be to determine the effect of lovastatin on CD4+ T-cell count in peripheral blood. As tertiary aims we will explore differences in CD8+ T-cell count, expression of activation markers (CD38 and HLA-DR on CD4 and CD8 T cells, cholesterol metabolism, LFA-1/ICAM-1 function, Rho GTPases function and clinical evolution between treated and not treated HIV-1-infected individuals. Discussion Preliminary descriptive studies have suggested that statins (lovastatin may have anti HIV-1 activity and that their administration is safe, with the potential effect of controlling HIV-1 replication in chronically infected individuals who had not received antiretroviral medications. Considering that there is limited clinical data available on

  12. Traceability of synthetic drugs by position-specific deuterium isotope ratio analysis

    Energy Technology Data Exchange (ETDEWEB)

    Brenna, Elisabetta [Dipartimento di Chimica, Materiali e di Ingegneria Chimica del Politecnico di Milano and Istituto CNR per la Chimica del Riconoscimento Molecolare, Via Mancinelli 7, Milan I-20131 (Italy)], E-mail: elisabetta.brenna@polimi.it; Fronza, Giovanni [Dipartimento di Chimica, Materiali e di Ingegneria Chimica del Politecnico di Milano (Italy) and Instituto CNR per la Chimica del Riconoscimento Molecolare, Via Mancinelli 7, Milan I-20131 (Italy)], E-mail: giovanni.fronza@polimi.it; Fuganti, Claudio [Dipartimento di Chimica, Materiali e di Ingegneria Chimica del Politecnico di Milano (Italy) and Istituto CNR per la Chimica del Riconoscimento Molecolare, Via Mancinelli 7, Milan I-20131 (Italy)

    2007-10-10

    Samples of fluoxetine of different origin were submitted to natural abundance {sup 2}H NMR spectroscopy. The deuterium content at the various sites of the molecule was found to depend on its synthetic history. Hints on the synthetic procedure can be obtained by comparison with standard compounds, whose synthesis is known. These preliminary results give an idea of the potential of site-specific isotope ratio analysis in the fight against patent infringement and drug counterfeiting.

  13. Traceability of synthetic drugs by position-specific deuterium isotope ratio analysis

    International Nuclear Information System (INIS)

    Brenna, Elisabetta; Fronza, Giovanni; Fuganti, Claudio

    2007-01-01

    Samples of fluoxetine of different origin were submitted to natural abundance 2 H NMR spectroscopy. The deuterium content at the various sites of the molecule was found to depend on its synthetic history. Hints on the synthetic procedure can be obtained by comparison with standard compounds, whose synthesis is known. These preliminary results give an idea of the potential of site-specific isotope ratio analysis in the fight against patent infringement and drug counterfeiting

  14. HIV antiretroviral medication stock-outs in Ghana: contributors and consequences.

    Science.gov (United States)

    Poku, Rebecca A; Owusu, Adobea Yaa; Mullen, Patricia Dolan; Markham, Christine; McCurdy, Sheryl A

    2017-09-01

    Drug stock-outs are an unfortunate yet common reality for patients living in low and middle income countries, particularly in sub-Saharan Africa where trouble with consistent stock of antiretroviral medications (ARVs) continues. Our study takes a snapshot of this problem in Ghana. Although the country launched its antiretroviral therapy (ART) programme in 2003, progress toward realising the full benefit of ART for treated individuals has been limited, in part, because of stock-outs. In Ghana's Greater Accra region, we conducted semi-structured interviews with 40 women living with HIV (WLHIV) and 15 individuals with a history of HIV-related work in government or non-governmental organisations, or healthcare facilities. We used repeated review with coding and mapping techniques to analyse the transcripts and identify common themes. Stock-outs of ARVs result in inconsistent administration of therapy, increased indirect medical costs for WLHIV, and negative labelling of patients. Inefficiencies in drug supply, poor coordination with port authorities, inadequate government funding and dependence on international aid contribute to the stock-outs experienced in Ghana. Although using ARVs produced in-country could reduce supply problems, the domestically-manufactured product currently does not meet World Health Organization (WHO) standards. We recommend focused efforts to produce WHO standard ARVs in Ghana, and a review of current supply chain management to identify and mend pitfalls in the system.

  15. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... people on HAART (highly active antiretroviral therapy), for example, who continue to misuse drugs. The Learn the Link public service campaign is just one example of how NIDA continues to respond to the ...

  16. Increased incidence of antiretroviral drug discontinuation among patients with viremic hepatitis C virus coinfection and high hyaluronic acid, a marker of liver fibrosis

    DEFF Research Database (Denmark)

    Grint, D.; Peters, L.; Rockstroh, J. K.

    2014-01-01

    HCV/HIV coinfected patients. Methods: EuroSIDA patients taking combination antiretroviral therapy were included. Poisson regression identified factors associated with antiretroviral treatment discontinuation. Results: A total of 9535 HIV-positive patients with known HCV status were included (6939...

  17. Antiretroviral purchasing and prescription practices in Mexico: constraints, challenges and opportunities

    OpenAIRE

    Chaumont, Claire; Bautista-Arredondo, Sergio; Calva, Juan José; Bahena-González, Roberto Isaac; Sánchez-Juárez, Gerda Hitz; González de Araujo-Muriel, Arturo; Magis-Rodríguez, Carlos; Hernández-Ávila, Mauricio

    2015-01-01

    Objective. This study examines the antiretroviral (ARV) market characteristics for drugs procured and prescribed to Mexico's Social Protection System in Health beneficiaries between 2008 and 2013, and compares them with international data. Materials and methods. Procurement information from the National Center for the Prevention and the Control of HIV/AIDS was analyzed to estimate volumes and prices of key ARV. Annual costs were compared with data from the World Health Organization's Global P...

  18. Risk-factors for non-adherence to antiretroviral therapy Fatores preditivos de não-adesão à terapia antiretroviral

    Directory of Open Access Journals (Sweden)

    Márcia Cristina Fraga Silva

    2009-06-01

    Full Text Available Cross-sectional study analyzed as case-control to identify risk factors for non-adherence to antiretroviral therapy. We studied 412 out-clinics HIV infected subjects of three public hospitals of Recife, Pernambuco. The objective was to examine the association between non-adherence to the antiretroviral therapy and biological, social-behavior and demographics and economic factors, factors related to the disease and/or treatment, factors related to life habits and depression symptoms. Variables significantly associated with non-adherence to antiretroviral therapy were: time elapsed since HIV diagnosis (p = 0.002, daily dose (p = 0.046, use of alcohol (p = 0.030 and past drug use (p = 0.048, and borderline p-values were found for educational level (p = 0.093 and family monthly income (p = 0.08. In the multivariable analysis, the factors that remained in the final model were family monthly income, time period with HIV infection and use of alcohol. No association was observed between non-adherence to antiretroviral therapy and gender, age, sexual orientation, marital status, educational level and place of residence. Based on our results and the local situation we suggest: assessment of social needs; training of partners and/or families on supporting adherence, creation of "adherence groups" to motivate and to reassure patients on the benefits of treatment; counseling and/or psychotherapy for alcohol drinkers.Estudo transversal com análise tipo caso-controle, que avaliou 412 pacientes de hospitais públicos do Recife - PE, com o objetivo de identificar fatores preditivos de não adesão à terapia antiretroviral. Verificou-se associação entre não adesão à terapia antiretroviral e aspectos biológicos, sócio-comportamentais e demográficos, econômicos, relacionados à doença e ao tratamento, aos hábitos de vida e aos distúrbios do humor. Variáveis com associação estatisticamente significante com não adesão na análise univariada foram

  19. Incidence of adverse drug reactions in human immune deficiency virus-positive patients using highly active antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    B Akshaya Srikanth

    2012-01-01

    Full Text Available To estimate the incidence of adverse drug reactions (ADRs in Human immune deficiency virus (HIV patients on highly active antiretroviral therapy (HAART. To identify the risk factors associated with ADRs in HIV patients. To analyze reported ADRs based on various parameters like causality, severity, predictability, and preventability. Retrospective case-control study. An 18-month retrospective case-control study of 208 patients newly registered in ART center, RIMS hospital, Kadapa, were intensively monitored for ADRs to HAART. Predictability was calculated based on the history of previous exposure to drug. Multivariate logistic regressions were used to identify the risk factors for ADRs. Data were analyzed using the chi-square test for estimating the correlation between ADRs and different variables. All statistical calculations were performed using EpiInfo version 3.5.3. Monitoring of 208 retrospective patients by active Pharmacovigilance identified 105 ADRs that were identified in 71 patients. Skin rash and anemia were the most commonly observed ADRs. The organ system commonly affected by ADR was skin and appendages (31.57%. The ADRs that were moderate were 90.14% of cases. The incidence of ADRs (53.52% was higher with Zidovudine + Lamivudine + Nevirapine combination. CD4 cell count less than <250 cells/μl were 80.28%, male gender were observed to be the risk factors for ADRs. Our study finding showed that there is a need of active pharmaceutical care with intensive monitoring for ADRs in Indian HIV-positive patients who are illiterate, of male and female gender, with CD4 count ≤250 cells/mm 3 with comorbid conditions.

  20. Photoluminescence of patterned CdSe quantum dot for anti-counterfeiting label on paper

    International Nuclear Information System (INIS)

    Isnaeni,; Yulianto, Nursidik; Suliyanti, Maria Margaretha

    2016-01-01

    We successfully developed a method utilizing colloidal CdSe nanocrystalline quantum dot for anti-counterfeiting label on a piece of glossy paper. We deposited numbers and lines patterns of toluene soluble CdSe quantum dot using rubber stamper on a glossy paper. The width of line pattern was about 1-2 mm with 1-2 mm separation between lines. It required less than one minute for deposited CdSe quantum dot on glossy paper to dry and become invisible by naked eyes. However, patterned quantum dot become visible using long-pass filter glasses upon excitation of UV lamp or blue laser. We characterized photoluminescence of line patterns of quantum dot, and we found that emission boundaries of line patterns were clearly observed. The error of line size and shape were mainly due to defect of the original stamper. The emission peak wavelength of CdSe quantum dot was 629 nm. The emission spectrum of deposited quantum dot has full width at half maximum (FWHM) of 30-40 nm. The spectra similarity between deposited quantum dot and the original quantum dot in solution proved that our stamping method can be simply applied on glossy paper without changing basic optical property of the quantum dot. Further development of this technique is potential for anti-counterfeiting label on very important documents or objects.

  1. Photoluminescence of patterned CdSe quantum dot for anti-counterfeiting label on paper

    Energy Technology Data Exchange (ETDEWEB)

    Isnaeni,, E-mail: isnaeni@lipi.go.id; Yulianto, Nursidik; Suliyanti, Maria Margaretha [Research Center for Physics, Indonesian Institute of Sciences, Building 442, Kawasan Puspiptek, South Tangerang,Banten 15314 Indonesia (Indonesia)

    2016-03-11

    We successfully developed a method utilizing colloidal CdSe nanocrystalline quantum dot for anti-counterfeiting label on a piece of glossy paper. We deposited numbers and lines patterns of toluene soluble CdSe quantum dot using rubber stamper on a glossy paper. The width of line pattern was about 1-2 mm with 1-2 mm separation between lines. It required less than one minute for deposited CdSe quantum dot on glossy paper to dry and become invisible by naked eyes. However, patterned quantum dot become visible using long-pass filter glasses upon excitation of UV lamp or blue laser. We characterized photoluminescence of line patterns of quantum dot, and we found that emission boundaries of line patterns were clearly observed. The error of line size and shape were mainly due to defect of the original stamper. The emission peak wavelength of CdSe quantum dot was 629 nm. The emission spectrum of deposited quantum dot has full width at half maximum (FWHM) of 30-40 nm. The spectra similarity between deposited quantum dot and the original quantum dot in solution proved that our stamping method can be simply applied on glossy paper without changing basic optical property of the quantum dot. Further development of this technique is potential for anti-counterfeiting label on very important documents or objects.

  2. Human resources needs for universal access to antiretroviral therapy in South Africa: a time and motion study

    NARCIS (Netherlands)

    Hontelez, J.A.C.; Newell, M.L.; Bland, R.M.; Munnelly, K.; Lessells, R.J.; Barnighausen, T.

    2012-01-01

    ABSTRACT: BACKGROUND: Although access to life-saving treatment for patients infected with HIV patients in South Africa has improved substantially since 2004, treating all eligible patients (universal access) remains elusive. As the prices of antiretroviral drugs have dropped over the past years,

  3. Improving adherence to antiretroviral therapy

    Directory of Open Access Journals (Sweden)

    Nischal K

    2005-01-01

    Full Text Available Antiretroviral therapy (ART has transformed HIV infection into a treatable, chronic condition. However, the need to continue treatment for decades rather than years, calls for a long-term perspective of ART. Adherence to the regimen is essential for successful treatment and sustained viral control. Studies have indicated that at least 95% adherence to ART regimens is optimal. It has been demonstrated that a 10% higher level of adherence results in a 21% reduction in disease progression. The various factors affecting success of ART are social aspects like motivation to begin therapy, ability to adhere to therapy, lifestyle pattern, financial support, family support, pros and cons of starting therapy and pharmacological aspects like tolerability of the regimen, availability of the drugs. Also, the regimen′s pill burden, dosing frequency, food requirements, convenience, toxicity and drug interaction profile compared with other regimens are to be considered before starting ART. The lack of trust between clinician and patient, active drug and alcohol use, active mental illness (e.g. depression, lack of patient education and inability of patients to identify their medications, lack of reliable access to primary medical care or medication are considered to be predictors of inadequate adherence. Interventions at various levels, viz. patient level, medication level, healthcare level and community level, boost adherence and overall outcome of ART.

  4. Tissue Pharmacologic and Virologic Determinants of Duodenal and Rectal Gastrointestinal-Associated Lymphoid Tissue Immune Reconstitution in HIV-Infected Patients Initiating Antiretroviral Therapy.

    Science.gov (United States)

    Asmuth, David M; Thompson, Corbin G; Chun, Tae-Wook; Ma, Zhong-Min; Mann, Surinder; Sainz, Talia; Serrano-Villar, Sergio; Utay, Netanya S; Garcia, Juan Carlos; Troia-Cancio, Paolo; Pollard, Richard B; Miller, Christopher J; Landay, Alan; Kashuba, Angela D

    2017-10-17

    Plasma, duodenal, and rectal tissue antiretroviral therapy (ART) drug concentrations, human immunodeficiency virus (HIV) RNA and HIV DNA copy numbers, and recovery of mucosal immunity were measured before and 9 months after initiation of 3 different ART regimens in 26 subjects. Plasma and tissue HIV RNA correlated at baseline and when 9-month declines were compared, suggesting that these compartments are tightly associated. Antiretroviral tissue:blood penetration ratios were above the 50% inhibitory concentration values in almost 100% of cases. There were no correlations between drug concentrations and HIV DNA/RNA. Importantly, no evidence was found for residual viral replication or deficient tissue drug penetration to account for delayed gastrointestinal-associated lymphoid tissue immune recovery. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  5. Health and federal budgetary effects of increasing access to antiretroviral medications for HIV by expanding Medicaid.

    Science.gov (United States)

    Kahn, J G; Haile, B; Kates, J; Chang, S

    2001-09-01

    OBJECTIVES. This study modeled the health and federal fiscal effects of expanding Medicaid for HIV-infected people to improve access to highly active antiretroviral therapy. A disease state model of the US HIV epidemic, with and without Medicaid expansion, was used. Eligibility required a CD4 cell count less than 500/mm3 or viral load greater than 10,000, absent or inadequate medication insurance, and annual income less than $10,000. Two benefits were modeled, "full" and "limited" (medications, outpatient care). Federal spending for Medicaid, Medicare, AIDS Drug Assistance Program, Supplemental Security Income, and Social Security Disability Insurance were assessed. An estimated 38,000 individuals would enroll in a Medicaid HIV expansion. Over 5 years, expansion would prevent an estimated 13,000 AIDS diagnoses and 2600 deaths and add 5,816 years of life. Net federal costs for all programs are $739 million (full benefits) and $480 million (limited benefits); for Medicaid alone, the costs are $1.43 and $1.17 billion, respectively. Results were sensitive to awareness of serostatus, highly active antiretroviral therapy cost, and participation rate. Strategies for federal cost neutrality include Medicaid HIV drug price reductions as low as 9% and private insurance buy-ins. Expansion of the Medicaid eligibility to increase access to antiretroviral therapy would have substantial health benefits at affordable costs.

  6. Drugs + HIV, Learn the Link

    Medline Plus

    Full Text Available ... Search Publications Orderable DrugFacts Research Reports Mind Over Matter Science of Addiction Funding Funding Opportunities Clinical Research ... is largely because of treatment with HAART (highly active antiretroviral therapy), a combination of three or more ...

  7. Characterization of HIV-1 antiretroviral drug resistance after second-line treatment failure in Mali, a limited-resources setting

    Science.gov (United States)

    Maiga, Almoustapha Issiaka; Fofana, Djeneba Bocar; Cisse, Mamadou; Diallo, Fodié; Maiga, Moussa Youssoufa; Traore, Hamar Alassane; Maiga, Issouf Alassane; Sylla, Aliou; Fofana, Dionke; Taiwo, Babafemi; Murphy, Robert; Katlama, Christine; Tounkara, Anatole; Calvez, Vincent; Marcelin, Anne-Geneviève

    2012-01-01

    Objectives We describe the outcomes of second-line drug resistance profiles and predict the efficacy of drugs for third-line therapy in patients monitored without the benefit of plasma HIV-1 RNA viral load (VL) or resistance testing. Methods We recruited 106 HIV-1-infected patients after second-line treatment failure in Mali. VL was determined by the Abbott RealTime system and the resistance by the ViroSeq HIV-1 genotyping system. The resistance testing was interpreted using the latest version of the Stanford algorithm. Results Among the 106 patients, 93 had isolates successfully sequenced. The median age, VL and CD4 cells were respectively 35 years, 72 000 copies/mL and 146 cells/mm3. Patients were exposed to a median of 4 years of treatment and to six antiretrovirals. We found 20% of wild-type viruses. Resistance to etravirine was noted in 38%, to lopinavir in 25% and to darunavir in 12%. The duration of prior nucleos(t)ide reverse transcriptase inhibitor exposure was associated with resistance to abacavir (P < 0.0001) and tenofovir (P = 0.0001), and duration of prior protease inhibitor treatment with resistance to lopinavir (P < 0.0001) and darunavir (P = 0.06). Conclusion Long duration of therapy prior to failure was associated with high levels of resistance and is directly related to limited access to VL monitoring and delayed switches to second-line treatment, precluding efficacy of drugs for third-line therapy. This study underlines the need for governments and public health organizations to recommend the use of VL monitoring and also the availability of darunavir and raltegravir for third-line therapies in the context of limited-resource settings. PMID:22888273

  8. Determinants of adherence to antiretroviral therapy among HIV-positive adults in sub-Saharan Africa: a systematic review

    NARCIS (Netherlands)

    Heestermans, Tessa; Browne, Joyce L; Aitken, Susan C; Vervoort, Sigrid C; Klipstein-Grobusch, Kerstin

    2016-01-01

    Objective The rapid scale up of antiretroviral treatment (ART) in sub-Saharan Africa (SSA) has resulted in an increased focus on patient adherence. Non-adherence can lead to drug-resistant HIV caused by failure to achieve maximal viral suppression. Optimal treatment requires the identification of

  9. Cholelithiasis and Nephrolithiasis in HIV-Positive Patients in the Era of Combination Antiretroviral Therapy.

    Directory of Open Access Journals (Sweden)

    Kuan-Yin Lin

    Full Text Available This study aimed to describe the epidemiology and risk factors of cholelithiasis and nephrolithiasis among HIV-positive patients in the era of combination antiretroviral therapy.We retrospectively reviewed the medical records of HIV-positive patients who underwent routine abdominal sonography for chronic viral hepatitis, fatty liver, or elevated aminotransferases between January 2004 and January 2015. Therapeutic drug monitoring of plasma concentrations of atazanavir was performed and genetic polymorphisms, including UDP-glucuronosyltransferase (UGT 1A1*28 and multidrug resistance gene 1 (MDR1 G2677T/A, were determined in a subgroup of patients who received ritonavir-boosted or unboosted atazanavir-containing combination antiretroviral therapy. Information on demographics, clinical characteristics, and laboratory testing were collected and analyzed.During the 11-year study period, 910 patients who underwent routine abdominal sonography were included for analysis. The patients were mostly male (96.9% with a mean age of 42.2 years and mean body-mass index of 22.9 kg/m2 and 85.8% being on antiretroviral therapy. The anchor antiretroviral agents included non-nucleoside reverse-transcriptase inhibitors (49.3%, unboosted atazanavir (34.4%, ritonavir-boosted lopinavir (20.4%, and ritonavir-boosted atazanavir (5.5%. The overall prevalence of cholelithiasis and nephrolithiasis was 12.5% and 8.2%, respectively. Among 680 antiretroviral-experienced patients with both baseline and follow-up sonography, the crude incidence of cholelithiasis and nephrolithiasis was 4.3% and 3.7%, respectively. In multivariate analysis, the independent factors associated with incident cholelithiasis were exposure to ritonavir-boosted atazanavir for >2 years (adjusted odds ratio [AOR], 6.29; 95% confidence interval [CI], 1.12-35.16 and older age (AOR, 1.04; 95% CI, 1.00-1.09. The positive association between duration of exposure to ritonavir-boosted atazanavir and incident

  10. The internet trade of counterfeit spirits in Russia – an emerging problem undermining alcohol, public health and youth protection policies? [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Maria Neufeld

    2017-06-01

    Full Text Available Counterfeit alcohol belongs to the category of unrecorded alcohol not reflected in official statistics. The internet trade of alcoholic beverages has been prohibited by the Russian Federation since 2007, but various sellers still offer counterfeit spirits (i.e., forged brand spirits over the internet to Russian consumers, mostly in a non-deceptive fashion at prices up to 15 times lower than in regular sale. The public health issues arising from this unregulated trade include potential harm to underage drinkers, hazards due to toxic ingredients such as methanol, but most importantly alcohol harms due to potentially increased drinking volumes due to low prices and high availability on the internet. The internet sale also undermines existing alcohol policies such as restrictions of sale locations, sale times and minimum pricing. The need to enforce measures against counterfeiting of spirits, but specifically their internet trade should be implemented as key elements of alcohol policies to reduce unrecorded alcohol consumption, which is currently about 33 % of total consumption in Russia.

  11. The internet trade of counterfeit spirits in Russia – an emerging problem undermining alcohol, public health and youth protection policies? [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Maria Neufeld

    2017-04-01

    Full Text Available Counterfeit alcohol belongs to the category of unrecorded alcohol not reflected in official statistics. The internet trade of alcoholic beverages has been prohibited by the Russian Federation since 2007, but various sellers still offer counterfeit spirits (i.e., forged brand spirits over the internet to Russian consumers, mostly in a non-deceptive fashion at prices up to 15 times lower than in regular sale. The public health issues arising from this unregulated trade include potential harm to underage drinkers, hazards due to toxic ingredients such as methanol, but most importantly alcohol harms due to potentially increased drinking volumes due to low prices and high availability on the internet. The internet sale also undermines existing alcohol policies such as restrictions of sale locations, sale times and minimum pricing. The need to enforce measures against counterfeiting of spirits, but specifically their internet trade should be implemented as key elements of alcohol policies to reduce unrecorded alcohol consumption, which is currently about 33 % of total consumption in Russia.

  12. The cost of antiretroviral therapy in Haiti

    Directory of Open Access Journals (Sweden)

    Fitzgerald Daniel W

    2008-02-01

    Full Text Available Abstract Background We determined direct medical costs, overhead costs, societal costs, and personnel requirements for the provision of antiretroviral therapy (ART to patients with AIDS in Haiti. Methods We examined data from 218 treatment-naïve adults who were consecutively initiated on ART at the GHESKIO Center in Port-au-Prince, Haiti between December 23, 2003 and May 20, 2004 and calculated costs and personnel requirements for the first year of ART. Results The mean total cost of treatment per patient was $US 982 including $US 846 in direct costs, $US 114 for overhead, and $US 22 for societal costs. The direct cost per patient included generic ART medications $US 355, lab tests $US 130, nutrition $US 117, hospitalizations $US 62, pre-ART evaluation $US 58, labor $US 51, non-ART medications $US 39, outside referrals $US 31, and telephone cards for patient retention $US 3. Higher treatment costs were associated with hospitalization, change in ART regimen, TB treatment, and survival for one year. We estimate that 1.5 doctors and 2.5 nurses are required to treat 1000 patients in the first year after initiating ART. Conclusion Initial ART treatment in Haiti costs approximately $US 1,000 per patient per year. With generic first-line antiretroviral drugs, only 36% of the cost is for medications. Patients who change regimens are significantly more expensive to treat, highlighting the need for less-expensive second-line drugs. There may be sufficient health care personnel to treat all HIV-infected patients in urban areas of Haiti, but not in rural areas. New models of HIV care are needed for rural areas using assistant medical officers and community health workers.

  13. Pharmacokinetics of antiretroviral drugs in infancy | McIlleron ...

    African Journals Online (AJOL)

    Dosing in infancy is complicated by inadequate characterisation of pharmacokinetics, unpredictable drug concentrations and a lack of suitable dosage forms. Additional challenges are presented by the concomitant administration of interacting drugs (e.g. rifampicin in antituberculosis treatment) and disease conditions that ...

  14. QUALITATIVE DRUG: WHAT SHOULD IT LOOK LIKE?

    Directory of Open Access Journals (Sweden)

    V. V. Iakusevich

    2006-01-01

    Full Text Available Drug quality in modern market is discussed. There is an increase of a number of drugs that don’t meet to the quality requirements.Most of them are produced by Russian manufacturers, which number has also increased recently. According to official data 6-10%of all medicines are counterfeit. Quality reduction is also connected with a huge number (80% of reproduced drugs (generics. Considerable part among generics doesn’t pass required evaluation of equivalence with original product. Approved deviations (according to Russian regulative rules in pharmacological equivalence may reach 5%, and in pharmacokinetic equivalence -25%. Evidences of pharmacodynamic (therapeutic equivalence are not required at all. At the same time, author advocates the production of qualitative generics that can providemodern and accessible treatment. Generic quality should be confirmed by randomized studies with cross-over designed comparison with original drug in parallel groups. The examples of the generics with such evidences are demonstrated. The requirements to the data about drugs are given to help the physician to make a right independent estimation of its quality.

  15. Brazil may stop HIV drug access; problems also reported from Argentina.

    Science.gov (United States)

    1999-09-03

    Brazil's financial crisis is threatening its HIV treatment programs, as well as programs for other diseases such as hemophilia, tuberculosis, diabetes, and malaria. The government is expected to stop providing antiretroviral therapy through the public health system in October. Meanwhile, the Argentine government stopped providing antiretroviral medications in August. Drug recycling programs are also discussed. Contact information is provided.

  16. Occurrence of transmitted HIV-1 drug resistance among Drug-naïve pregnant women in selected HIV-care centres in Ghana.

    Science.gov (United States)

    Martin-Odoom, Alexander; Adiku, Theophilus; Delgado, Elena; Lartey, Margaret; Ampofo, William K

    2017-03-01

    Access to antiretroviral therapy in Ghana has been scaled up across the country over the last decade. This study sought to determine the occurrence of transmitted HIV-1 drug resistance in pregnant HIV-1 positive women yet to initiate antiretroviral therapy at selected HIV Care Centres in Ghana. Plasma specimens from twenty-six (26) HIV seropositive pregnant women who were less than 28weeks pregnant with their first pregnancy and ART naïve were collected from selected HIV care centres in three (3) regions in Ghana. Genotypic testing was done for the reverse transcriptase gene and the sequences generated were analyzed for HIV-1 drug resistance mutations using the Stanford University HIV Drug Resistance Database. Resistance mutations associated with the reverse transcriptase gene were detected in 4 (15.4%) of the participants. At least one major drug resistance mutation in the reverse transcriptase gene was found in 3 (11.5%) of the women. The detection of transmitted HIV-1 drug resistance in this drug-naïve group in two regional HIV care sites is an indication of the need for renewed action in monitoring the emergence of transmitted HIV-1 drug resistance in Ghana. None declared.

  17. Comparative analysis of drug resistance mutations in the human immunodeficiency virus reverse transcriptase gene in patients who are non-responsive, responsive and naive to antiretroviral therapy.

    Science.gov (United States)

    Misbah, Mohammad; Roy, Gaurav; Shahid, Mudassar; Nag, Nalin; Kumar, Suresh; Husain, Mohammad

    2016-05-01

    Drug resistance mutations in the Pol gene of human immunodeficiency virus 1 (HIV-1) are one of the critical factors associated with antiretroviral therapy (ART) failure in HIV-1 patients. The issue of resistance to reverse transcriptase inhibitors (RTIs) in HIV infection has not been adequately addressed in the Indian subcontinent. We compared HIV-1 reverse transcriptase (RT) gene sequences to identify mutations present in HIV-1 patients who were ART non-responders, ART responders and drug naive. Genotypic drug resistance testing was performed by sequencing a 655-bp region of the RT gene from 102 HIV-1 patients, consisting of 30 ART-non-responding, 35 ART-responding and 37 drug-naive patients. The Stanford HIV Resistance Database (HIVDBv 6.2), IAS-USA mutation list, ANRS_09/2012 algorithm, and Rega v8.02 algorithm were used to interpret the pattern of drug resistance. The majority of the sequences (96 %) belonged to subtype C, and a few of them (3.9 %) to subtype A1. The frequency of drug resistance mutations observed in ART-non-responding, ART-responding and drug-naive patients was 40.1 %, 10.7 % and 20.58 %, respectively. It was observed that in non-responders, multiple mutations were present in the same patient, while in responders, a single mutation was found. Some of the drug-naive patients had more than one mutation. Thymidine analogue mutations (TAMs), however, were found in non-responders and naive patients but not in responders. Although drug resistance mutations were widely distributed among ART non-responders, the presence of resistance mutations in the viruses of drug-naive patients poses a big concern in the absence of a genotyping resistance test.

  18. Protecting the fetus against HIV infection: a systematic review of placental transfer of antiretrovirals.

    Science.gov (United States)

    McCormack, Shelley A; Best, Brookie M

    2014-11-01

    Maternal-to-fetal transfer of antiretroviral drugs contributes to prevention of vertical transmission of HIV. This systematic review discusses published studies containing data pertaining to the pharmacokinetics of placental transfer of antiretrovirals in humans, including paired cord and maternal plasma samples collected at the time of delivery as well as ex vivo placental perfusion models. Articles pertaining to placental transfer of antiretrovirals were identified from PubMed, from references of included articles, and from US Department of Health and Human Services Panel on Treatment of HIV-infected Pregnant Women and Prevention of Perinatal Transmission guidelines. Articles from non-human animal models or that had no original maternal-to-fetal transfer data were excluded. PRISMA guidelines were followed. A total of 103 published studies were identified. Data across studies appeared relatively consistent for the nucleoside reverse transcriptase inhibitors (NRTIs) and the non-nucleotide reverse transcriptase inhibitors (NNRTIs), with cord to maternal ratios approaching 1 for many of these agents. The protease inhibitors atazanavir and lopinavir exhibited consistent maternal-to-fetal transfer across studies, although the transfer may be influenced by variations in drug-binding proteins. The protease inhibitors indinavir, nelfinavir, and saquinavir exhibited unreliable placental transport, with cord blood concentrations that were frequently undetectable. Limited data, primarily from case reports, indicate that darunavir and raltegravir provide detectable placental transfer. These findings appear consistent with current guidelines of using two NRTIs plus an NNRTI, atazanavir/ritonavir, or lopinavir/ritonavir to maximize placental transfer as well as to optimally suppress maternal viral load. Darunavir/ritonavir and raltegravir may reasonably serve as second-line agents.

  19. [Illicit drug use by pregnant women infected with HIV].

    Science.gov (United States)

    Melo, Victor Hugo; Botelho, Ana Paula Machado; Maia, Marcelle Marie Martins; Correa, Mário Dias; Pinto, Jorge Andrade

    2014-12-01

    To determine if illicit drug use increases the vertical transmission of HIV, to identify the risk factors involved in mother and child health and the prevalence of illicit drug use among these pregnant women. Sixty-four (7.6%) of 845 pregnant women from the metropolitan region of Belo Horizonte, Minas Gerais, Brazil, attended in the service between October 1997 and February 2012 reported the use of illicit drugs. Cases were HIV-positive drug users (n=64) and controls were women who did not use drugs (n=192). Three controls were selected for each case. Several conditions of exposure were considered in the control group such as tobacco use, alcohol use, alcohol and tobacco use, maternal age, educational level, ethnicity, and marital status. Problems during the prenatal period, delivery and postpartum, vertical HIV transmission and neonatal outcomes were also investigated. Univariate analysis showed as significant variables: maternal age, tobacco use, number of prenatal care visits, antiretroviral therapy, mode of infection, and viral load at delivery. Logistic regression revealed as significant variables: maternal age (less than 25 years); tobacco use, and number of prenatal care visits (less than 6). The vertical transmission of HIV was 4,8% (95%CI 1.7-13.3) among drug users and 2,1% (95%CI 0.8-5.2) in the control group, with no statistically significant difference between groups. Neonatal complications were more frequent among drug users, but also with no statistically significant difference between groups. The use of illicit drug is frequent during pregnancy among HIV-infected women. The approach to illicit drug use should be routine during prenatal care visits. These women are more discriminated against and tend to deny their habits or do not seek prenatal care. There was no difference in vertical virus transmission between groups, probably indicating adherence to antiretroviral use for antiretroviral therapies during pregnancy.

  20. From Drug Safety to Drug Security: A Contemporary Shift in the Policing of Health.

    Science.gov (United States)

    Hornberger, Julia

    2018-01-29

    The counterfeiting of medication is increasingly seen as a major threat to health, especially in the light of both the everyday reliance on and a broadening of world-wide access to pharmaceuticals. Exaggerated or real, this threat has inaugurated, this article argues, a shift from a drug safety regime to a drug security regime that governs the flow of pharmaceuticals and brings together markets, police, and health actors in new ways. This entails a shift from soft disciplinary means aimed at incremental and continued inclusion of defaulters, to one of drastically sovereign measures of exclusion and banishment aimed at fake goods and the people associated with them, in the name of health. Through a multi-sited ethnographic study, this article shows how such new drug security efforts play themselves out especially in (South) Africa, highlighting a modus operandi of spectacular performativity and of working through suspicion and association rather than factuality, producing value less so for those in need of health than for a petty security industry itself. © 2018 by the American Anthropological Association.

  1. Contracepção hormonal e anti-retrovirais em mulheres infectadas pelo HIV Hormonal contraception and antiretroviral therapy among HIV-infected women

    Directory of Open Access Journals (Sweden)

    Eliana Amaral

    2006-11-01

    Full Text Available Há controvérsia sobre a relação entre o uso de contraceptivos hormonais e o risco de adquirir o vírus da imunodeficiência humana (HIV, e pouco se sabe sobre os efeitos da contracepção hormonal em mulheres infectadas (efeitos colaterais, distúrbios menstruais, progressão da doença, interações com terapias anti-retrovirais. O objetivo deste artigo foi revisar os dados disponíveis quanto à vulnerabilidade ao HIV e à sua transmissibilidade na vigência do uso de contraceptivos hormonais bem como as conseqüências potenciais do uso desses contraceptivos por mulheres HIV-positivas sob terapia anti-retroviral (TARV, com ênfase nas interações medicamentosas. Concluiu-se que ainda não é possível elaborar recomendações, baseadas em evidências, sobre a contracepção hormonal em mulheres portadoras do HIV sob TARV. Assim, os infectologistas e os ginecologistas devem estar atentos às interações potenciais que possam representar aumento de efeitos adversos, individualizando a orientação sobre os esteróides contraceptivos, suas doses e vias de administração, considerando a TARV em uso.There is much controversy regarding the realtionship between the use of hormonal contraceptives and the risk of acquiring human immunodeficiency virus (HIV, and little is known about the effects of hormonal contraception in HIV-infected women (adverse events, menstrual disorders, disease progression, antiretroviral therapy interactions. The aim of the present study was to review available data regarding HIV vulnerability and transmission associated with hormonal contraceptives and the use of these contraceptives by women on antiretroviral therapy, with emphasis on drug interactions. In conclusion, it was not possible to offer evidence-based recommendations for the use of hormonal contraceptives among HIV-infected women under antiretroviral therapy. Infectious disease specialists and gynecologists providing care should be cautious about potential

  2. Identifying the composition of street drug Nyaope using two different ...

    African Journals Online (AJOL)

    The constituents consistently detected in all samples were caffeine, drugs of abuse such as opiates, codeine, morphine, methyl-dioxy amphetamine (MDA) and heroin. Some samples contained antibiotics (citroflex) and antiretroviral drugs (zidovudine). Central nervous system (CNS) depressants such as phenobarbitone ...

  3. Detection and Management of Adverse Drug Reactions Related to ...

    African Journals Online (AJOL)

    The objective of this study was to establish the detection, prevalence and management of various adverse drug reactions associated with antiretroviral drugs occurring in patients attending Comprehensive Care Centre (CCC) of Kiambu District Hospital. The study was a cross sectional survey where the patients included ...

  4. Antiretroviral therapy programme on control of HIV transmission in ...

    African Journals Online (AJOL)

    Antiretroviral therapy programme on control of HIV transmission in Morogoro municipality, Tanzania: A challenge for development. ... The government and partners should improve access to ART services to enable many PLHIV to access the services. Key words: Antiretroviral Therapy, Highly Active Antiretroviral Treatment, ...

  5. Self-perception of knowledge and adherence reflecting the effectiveness of antiretroviral therapy.

    Science.gov (United States)

    Dagli-Hernandez, Carolina; Lucchetta, Rosa Camila; de Nadai, Tales Rubens; Galduróz, José Carlos Fernandez; Mastroianni, Patricia de Carvalho

    2016-01-01

    To evaluate which indirect method for assessing adherence best reflects highly active antiretroviral therapy (HAART) effectiveness and the factors related to adherence. This descriptive, cross-sectional study was performed in 2012 at a reference center of the state of São Paulo. Self-report (simplified medication adherence questionnaire [SMAQ]) and drug refill parameters were compared to the viral load (clinical parameter of the effectiveness of pharmacotherapy [EP]) to evaluate the EP. The "Cuestionario para la Evaluación de la Adhesión al Tratamiento Antiretroviral" (CEAT-VIH) was used to evaluate factors related to adherence and the EP and, complementarily, patient self-perception of adherence was compared to the clinical parameter of the EP. Seventy-five patients were interviewed, 60 of whom were considered as adherent from the clinical parameter of the EP and ten were considered as adherent from all parameters. Patient self-perception about adherence was the instrument that best reflected the EP when compared to the standardized self-report questionnaire (SMAQ) and drug refill parameter. The level of education and the level of knowledge on HAART were positively correlated to the EP. Forgetfulness, alcohol use, and lack of knowledge about the medications were the factors most frequently reported as a cause of nonadherence. A new parameter of patient self-perception of adherence, which is a noninvasive, inexpensive instrument, could be applied and assessed as easily as self-report (SMAQ) during monthly drug refill, since it allows monitoring adherence through pharmaceutical assistance. Therefore, patient adherence to HAART could be evaluated using self-perception (CEAT-VIH) and the viral load test.

  6. Terahertz absorption spectra of commonly used antimalarial drugs

    Science.gov (United States)

    Bawuah, Prince; Zeitler, J. Axel; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2018-06-01

    Terahertz (THz) spectra from the pure forms [i.e. the active pharmaceutical ingredients (APIs)] of four commonly used antimalarial drugs are reported. The well-defined spectral fingerprints obtained for these APIs in the spectral range of 0.1 THz-3 THz show the sensitivity of the THz time-domain spectroscopic (THz-TDS) method for screening antimalarial drugs. For identification purpose, two commercially available antimalarial tablets were detected. Clear spectral fingerprints of the APIs in the antimalarial tablets were obtained even amidst the several types of excipients present in the tablets. This observation further proves the high sensitivity of the THz techniques in tracking the presence or absence of API in a pharmaceutical tablet. We envisage that the spectral data obtained for these drugs can contribute to a spectroscopic database in the far infrared spectral region and hence support the modelling of THz sensing to differentiate between genuine and counterfeit antimalarial tablets.

  7. Terahertz absorption spectra of commonly used antimalarial drugs

    Science.gov (United States)

    Bawuah, Prince; Zeitler, J. Axel; Ketolainen, Jarkko; Peiponen, Kai-Erik

    2018-03-01

    Terahertz (THz) spectra from the pure forms [i.e. the active pharmaceutical ingredients (APIs)] of four commonly used antimalarial drugs are reported. The well-defined spectral fingerprints obtained for these APIs in the spectral range of 0.1 THz-3 THz show the sensitivity of the THz time-domain spectroscopic (THz-TDS) method for screening antimalarial drugs. For identification purpose, two commercially available antimalarial tablets were detected. Clear spectral fingerprints of the APIs in the antimalarial tablets were obtained even amidst the several types of excipients present in the tablets. This observation further proves the high sensitivity of the THz techniques in tracking the presence or absence of API in a pharmaceutical tablet. We envisage that the spectral data obtained for these drugs can contribute to a spectroscopic database in the far infrared spectral region and hence support the modelling of THz sensing to differentiate between genuine and counterfeit antimalarial tablets.

  8. Delivery of antiretroviral treatment services in India: Estimated costs incurred under the National AIDS Control Programme.

    Science.gov (United States)

    Agarwal, Reshu; Rewari, Bharat Bhushan; Shastri, Suresh; Nagaraja, Sharath Burugina; Rathore, Abhilakh Singh

    2017-04-01

    Competing domestic health priorities and shrinking financial support from external agencies necessitates that India's National AIDS Control Programme (NACP) brings in cost efficiencies to sustain the programme. In addition, current plans to expand the criteria for eligibility for antiretroviral therapy (ART) in India will have significant financial implications in the near future. ART centres in India provide comprehensive services to people living with HIV (PLHIV): those fulfilling national eligibility criteria and receiving ART and those on pre-ART care, i.e. not on ART. ART centres are financially supported (i) directly by the NACP; and (ii) indirectly by general health systems. This study was conducted to determine (i) the cost incurred per patient per year of pre-ART and ART services at ART centres; and (ii) the proportion of this cost incurred by the NACP and by general health systems. The study used national data from April 2013 to March 2014, on ART costs and non-ART costs (human resources, laboratory tests, training, prophylaxis and management of opportunistic infections, hospitalization, operational, and programme management). Data were extracted from procurement records and reports, statements of expenditure at national and state level, records and reports from ART centres, databases of the National AIDS Control Organisation, and reports on use of antiretroviral drugs. The analysis estimates the cost for ART services as US$ 133.89 (?8032) per patient per year, of which 66% (US$ 88.66, ?5320) is for antiretroviral drugs and 34% (US$ 45.23, ?2712) is for non-ART recurrent expenditure, while the cost for pre-ART care is US$ 33.05 (?1983) per patient per year. The low costs incurred for patients in ART and pre-ART care services can be attributed mainly to the low costs of generic drugs. However, further integration with general health systems may facilitate additional cost saving, such as in human resources.

  9. Aspect of the Characters from The Counterfeiters of André Gide

    Directory of Open Access Journals (Sweden)

    Hülya Kol

    2017-07-01

    Full Text Available As a pastry chef, the writer André Gide kneads his dough differently with the intention of putting an end to imitation in the world of the novel. He has the courage to treat the subject of the novel on the contrary to his contemporaries. He succeeds by introducing the reader into the novel. The reader finds fantastic stories and interesting characters in The Counterfeiters. Themes such as the hypocrisy and falsity of these characters are a reflection of the title that evokes them. Gide transmits this problematic period to the reader with surprising skill. The contrast in the words and behaviors of people are the evil traces of war.

  10. Antiretroviral therapy drug adherence in Rwanda: perspectives from patients and healthcare workers using a mixed-methods approach

    NARCIS (Netherlands)

    Vyankandondera, Joseph; Mitchell, Kirstin; Asiimwe-Kateera, Brenda; Boer, Kimberly; Mutwa, Philippe; Balinda, Jean-Paul; van Straten, Masja; Reiss, Peter; van de Wijgert, Janneke

    2013-01-01

    Rwanda has achieved high enrollment into antiretroviral therapy (ART) programs but data on adherence after enrollment are not routinely collected. We used a mixed-methods approach (standardized questionnaires, pill counts, focus group discussions, and in-depth interviews) to determine levels of and

  11. Biomedicine, public health, and citizenship in the advent of antiretrovirals in Botswana.

    Science.gov (United States)

    Chabrol, Fanny

    2014-08-01

    Often celebrated as a model of development in Africa, Botswana nonetheless endured a severe HIV epidemic. This article describes the singularity of the Botswana experience in facing AIDS and creating the widest possible access to antiretroviral medications for its citizens. Through exploration of different sets of actors and the construction of their ethics of treatment, it is possible to examine how free and universal access was created within the national antiretroviral program. This article underscores the importance of the site and the local dynamics in the advent of an ethics of access to treatment for Botswana citizens. At the intersection of national citizenship, pharmaceutical philanthropy, and biomedical collaborations, Botswana is an exemplary case (one of the first and unique in its kind) of global health programs for access to drugs in which patients' rights are tied to science and pharmaceutical development. As such it also bears some limitations and concerns over its sustainability. © 2014 John Wiley & Sons Ltd.

  12. Potential Impact of a Free Online HIV Treatment Response Prediction System for Reducing Virological Failures and Drug Costs after Antiretroviral Therapy Failure in a Resource-Limited Setting

    Directory of Open Access Journals (Sweden)

    Andrew D. Revell

    2013-01-01

    Full Text Available Objective. Antiretroviral drug selection in resource-limited settings is often dictated by strict protocols as part of a public health strategy. The objective of this retrospective study was to examine if the HIV-TRePS online treatment prediction tool could help reduce treatment failure and drug costs in such settings. Methods. The HIV-TRePS computational models were used to predict the probability of response to therapy for 206 cases of treatment change following failure in India. The models were used to identify alternative locally available 3-drug regimens, which were predicted to be effective. The costs of these regimens were compared to those actually used in the clinic. Results. The models predicted the responses to treatment of the cases with an accuracy of 0.64. The models identified alternative drug regimens that were predicted to result in improved virological response and lower costs than those used in the clinic in 85% of the cases. The average annual cost saving was $364 USD per year (41%. Conclusions. Computational models that do not require a genotype can predict and potentially avoid treatment failure and may reduce therapy costs. The use of such a system to guide therapeutic decision-making could confer health economic benefits in resource-limited settings.

  13. Regional differences in use of antiretroviral agents and primary prophylaxis in 3122 European HIV-infected patients. EuroSIDA Study Group

    DEFF Research Database (Denmark)

    Lundgren, Jens Dilling; Phillips, A N; Vella, S

    1997-01-01

    Little is known about how widely HIV-related drugs are used outside controlled clinical trials. We therefore assessed factors associated with use of antiretroviral (ARV) therapy and primary prophylactic regimens to prevent HIV-associated opportunistic infections. Baseline data from a prospective ...

  14. The Prescription Drug Marketing Act of 1987.

    Science.gov (United States)

    Greenberg, R B

    1988-10-01

    The Prescription Drug Marketing Act of 1987 is described, and its implications for hospitals and other health-care entities are discussed. The act, which became effective on July 21, 1988, is intended to reduce public health risks from adulterated, misbranded, and counterfeit drug products that enter the marketplace through drug diversion. The law provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product's manufacturer. It also establishes restrictions on sales of prescription drug products and samples. Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Other distribution channels for samples specified in the law are permissible, provided records are maintained. Under the law, wholesale distributors must be licensed by the state and meet uniform standards. Penalties for violations of the law are also identified. According to FDA's advisory guidelines on the statute, the law will permit hospitals to return drug products, provided the return is made to the manufacturer or wholesaler and provided written notice is secured that the goods were received (for manufacturers) or the goods were destroyed or returned to the manufacturer (for wholesalers). The final chapter on drug diversion must await issuance of final FDA regulations.

  15. Mutations Related to Antiretroviral Resistance Identified by Ultra-Deep Sequencing in HIV-1 Infected Children under Structured Interruptions of HAART.

    Directory of Open Access Journals (Sweden)

    Jose Manuel Vazquez-Guillen

    Full Text Available Although Structured Treatment Interruptions (STI are currently not considered an alternative strategy for antiretroviral treatment, their true benefits and limitations have not been fully established. Some studies suggest the possibility of improving the quality of life of patients with this strategy; however, the information that has been obtained corresponds mostly to studies conducted in adults, with a lack of knowledge about its impact on children. Furthermore, mutations associated with antiretroviral resistance could be selected due to sub-therapeutic levels of HAART at each interruption period. Genotyping methods to determine the resistance profiles of the infecting viruses have become increasingly important for the management of patients under STI, thus low-abundance antiretroviral drug-resistant mutations (DRM's at levels under limit of detection of conventional genotyping (<20% of quasispecies could increase the risk of virologic failure. In this work, we analyzed the protease and reverse transcriptase regions of the pol gene by ultra-deep sequencing in pediatric patients under STI with the aim of determining the presence of high- and low-abundance DRM's in the viral rebounds generated by the STI. High-abundance mutations in protease and high- and low-abundance mutations in reverse transcriptase were detected but no one of these are directly associated with resistance to antiretroviral drugs. The results could suggest that the evaluated STI program is virologically safe, but strict and carefully planned studies, with greater numbers of patients and interruption/restart cycles, are still needed to evaluate the selection of DRM's during STI.

  16. Quality of life of people living with HIV and AIDS and antiretroviral therapy.

    Science.gov (United States)

    Oguntibeju, Oluwafemi O

    2012-01-01

    The development of antiretroviral drugs has significantly changed the perception of HIV/AIDS from a very fatal to a chronic and potentially manageable disease, and the availability and administration of antiretroviral therapy (ART) has significantly reduced mortality and morbidity associated with HIV and AIDS. There is a relationship between ART and quality of life of people living with HIV and AIDS, and several studies have reported a strong positive association between ART and improved quality of life in different domains among people living with HIV and AIDS in both developed and developing countries. However, a few studies have reported on the negative effects of ART, which directly or indirectly relate to the quality of life and longevity of HIV-infected persons. In this review, the effects and benefits of ART on people living with HIV and AIDS based on studies done in developed and developing countries is examined.

  17. Quality of life of people living with HIV and AIDS and antiretroviral therapy

    Science.gov (United States)

    Oguntibeju, Oluwafemi O

    2012-01-01

    The development of antiretroviral drugs has significantly changed the perception of HIV/AIDS from a very fatal to a chronic and potentially manageable disease, and the availability and administration of antiretroviral therapy (ART) has significantly reduced mortality and morbidity associated with HIV and AIDS. There is a relationship between ART and quality of life of people living with HIV and AIDS, and several studies have reported a strong positive association between ART and improved quality of life in different domains among people living with HIV and AIDS in both developed and developing countries. However, a few studies have reported on the negative effects of ART, which directly or indirectly relate to the quality of life and longevity of HIV-infected persons. In this review, the effects and benefits of ART on people living with HIV and AIDS based on studies done in developed and developing countries is examined. PMID:22893751

  18. Frequent hepatitis B virus rebound among HIV-hepatitis B virus-coinfected patients following antiretroviral therapy interruption

    DEFF Research Database (Denmark)

    Dore, Gregory J; Soriano, Vicente; Rockstroh, Jürgen

    2010-01-01

    .0002), nondetectable HBV DNA at baseline (P = 0.007), and black race (P = 0.03). Time to ART reinitiation was shorter (7.5, 15.6, and 17.8 months; P hepatitis C virus-positive and non-HBV/hepatitis...... C virus participants in the drug conservation arm. No hepatic decompensation events occurred among HBV-positive participants in either arm. CONCLUSION: HBV DNA rebound following ART interruption is common and may be associated with accelerated immune deficiency in HIV-HBV-coinfected patients.......BACKGROUND: The impact of antiretroviral therapy (ART) interruption in HIV-hepatitis B virus (HBV)-coinfected patients was examined in the Strategic Management of AntiRetroviral Therapy (SMART) study. METHODS: Plasma HBV DNA was measured in all hepatitis B surface antigen-positive (HBV...

  19. HIV multi-drug resistance at first-line antiretroviral failure and subsequent virological response in Asia

    OpenAIRE

    Jiamsakul, Awachana; Sungkanuparph, Somnuek; Law, Matthew; Kantor, Rami; Praparattanapan, Jutarat; Li, Patrick CK; Phanuphak, Praphan; Merati, Tuti; Ratanasuwan, Winai; Lee, Christopher KC; Ditangco, Rossana; Mustafa, Mahiran; Singtoroj, Thida; Kiertiburanakul, Sasisopin

    2014-01-01

    Introduction: First-line antiretroviral therapy (ART) failure often results from the development of resistance-associated mutations (RAMs). Three patterns, including thymidine analogue mutations (TAMs), 69 Insertion (69Ins) and the Q151M complex, are associated with resistance to multiple-nucleoside reverse transcriptase inhibitors (NRTIs) and may compromise treatment options for second-line ART. Methods: We investigated patterns and factors associated with multi-NRTI RAMs at first-line failu...

  20. The incidence and types of medication errors in patients receiving antiretroviral therapy in resource-constrained settings.

    Directory of Open Access Journals (Sweden)

    Kenneth Anene Agu

    Full Text Available This study assessed the incidence and types of medication errors, interventions and outcomes in patients on antiretroviral therapy (ART in selected HIV treatment centres in Nigeria.Of 69 health facilities that had program for active screening of medication errors, 14 were randomly selected for prospective cohort assessment. All patients who filled/refilled their antiretroviral medications between February 2009 and March 2011 were screened for medication errors using study-specific pharmaceutical care daily worksheet (PCDW. All potential or actual medication errors identified, interventions provided and the outcomes were documented in the PCDW. Interventions included pharmaceutical care in HIV training for pharmacists amongst others. Chi-square was used for inferential statistics and P0.05. The major medications errors identified were 26.4% incorrect ART regimens prescribed; 19.8% potential drug-drug interaction or contraindication present; and 16.6% duration and/or frequency of medication inappropriate. Interventions provided included 67.1% cases of prescriber contacted to clarify/resolve errors and 14.7% cases of patient counselling and education; 97.4% of potential/actual medication error(s were resolved.The incidence rate of medication errors was somewhat high; and majority of identified errors were related to prescription of incorrect ART regimens and potential drug-drug interactions; the prescriber was contacted and the errors were resolved in majority of cases. Active screening for medication errors is feasible in resource-limited settings following a capacity building intervention.