Patents and Licences on Antiretrovirals: A Snapshot. Burrone E and Timmermans K. (2014)

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The report provides an overview of the patent landscape with respect to a select number of antiretroviral (ARV) medicines in developing countries as of April 2014. The focus is primarily on those ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.

Part 1 provides a brief introduction to patents and licences and their effect on the market for ARVs. It introduces key concepts that will facilitate an understanding of the report. It also explains which data sources were used for the report and notes a number of disclaimers with regard to the information contained in the report. Part 2 is the core of the report. It outlines the patent status and licensing status of each ARV in the 81 developing countries for which data are available. For each ARV the report indicates whether that ARV is included in fixed-dose combinations for which there may be patents. General conclusions are drawn in light of the data. The key purpose is to provide an overview of the patent landscape for each ARV and, in particular, to show in which countries market competition for a given ARV is possible in view of existing patents and licences.

 

Keywords: HIV, treatment, medicines, ART, ARV

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March 2014 Supplement to the 2013 Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. WHO. (2014)

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WHO guidelines on the use of antiretroviral (ARV) drugs for treating and preventing HIV infection provide a public health approach for scaling up HIV care and treatment programmes and focus on simplified, harmonized and effective antiretroviral therapy (ART) regimens for use in resource-limited settings. In 2013, for the first time, WHO revised and combined guidelines for adults and adolescents, infants and children and pregnant women as well as other ARV-related guidance documents into one set of consolidated guidelines that addressed the use of ARV drugs for HIV treatment and prevention across all age groups and populations, based on the broad continuum of HIV care.

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Antimicrobial Resistance: Global Report on Surveillance. WHO. (2014)

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The report is intended to provide information primarily for public health policy-makers and managers, and for the wider medical and public health community (including pharmaceutical companies), as a support for informing strategic actions and programme planning. It will also be of interest to the other sectors that are directly involved, including veterinary drug and animal husbandry, agriculture and aquaculture.


Keywords: HIV, drug resistance, tuberculosis (TB), medicines

 


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An Ambitious Treatment Target to Help End the AIDS Epidemic. UNAIDS. (2014)

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HIV treatment is a unique tool in the AIDS response, preventing illness and death, averting new infections and saving money. As hopes for ending the AIDS epidemic depend  in large measure on the world’s ability to provide HIV treatment to all who need it, in a rights-based approach, final targets for universal treatment access are critical.

 

Keywords: HIV, coverage, testing, antiretroviral therapy (ART), antiretroviral drugs (ARV), key populations, 90-90-90

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A Review of the Delamanid Patent Landscape: A Scoping Report. Amin T. (2014)

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Delamanid was discovered via a screening programme carried out by Otsuka. The compound belongs to the nitroimidazole class of compounds and is a derivative of compound CGI-17341 whose anti-TB activity was already reported in 1993.4 Indeed, various 5- and 2-nitroimidazoles and 5-nitrofurans were already known to be effective against a variety of protozoan and bacterial infections in humans and animals. For example, the published international patent application WO 97/01562 previously disclosed a 6-nitro- 1,2,3,4-tetrahydro[2,1-b]-imidazopyran compound with bactericidal action in vitro to mycobacterium TB.

 

Keywords: HIV, TB, pediatric, testing, drugs, treatment

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Making Fair Choices on the Path to Universal Health Coverage. WHO. (2014)

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Universal health coverage (UHC) is at the center of current efforts to strengthen health systems and improve the level and distribution of health and health services. This document is the final report of the WHO Consultative Group on Equity and Universal Health Coverage. The report addresses the key issues of fairness and equity that arise on the path to UHC. As such, the report is relevant for every actor that affects that path and governments in particular, as they are in charge of overseeing and guiding the progress toward UHC.

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Surveillance of HIV Drug Resistance in Populations Initiating Antiretroviral Therapy (Pre-treatment HIV Drug Resistance). WHO. (2014)

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Nationally representative surveillance of HIVDR in populations initiating a standard triple-drug ART combination is critical to inform the selection of effective first-line ART combinations, as well as adequate pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) regimens. Detected HIVDR in populations initiating triple-drug ART regimens may have been transmitted at the time of initial infection or acquired due to previous exposure to antiretroviral (ARV) drugs (in the context of prevention of mother-to-child transmission (PMTCT) programmes, PrEP, PEP or previous disclosed or undisclosed ART).

 

Keywords: HIV, drug resistance, infections, epidemiology, therapy, surveillance

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Policy Brief: Consolidated Guidelines on HIV Prevention, Diagnosis, Treatment and Care for Key Populations. WHO (2014)

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This policy brief provides an overview of key findings, data and figures of the new consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. In addition, it offers an overview of the comprehensive package on interventions and a table summarizing WHO recommendations concerning key populations.

 

Keywords: HIV, men who have sex with men (MSM), people who inject drugs (PWID), sex workers, transgender, testing, treatment

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A Review of the PA-824 Patent Landscape: A Scoping Report. Amin T. (2014)

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Like delamanid, PA-824 belongs to the nitroimidazoles class of compounds and is a derivative of compound CGI-17341 whose anti-TB activity was reported as early as 1993.3 PA-824 was discovered by Patho- Genesis Corporation, which was subsequently acquired by Chiron Corporation. Novartis AG acquired Chiron Corporation in 2006.

PA-824 is a pro-drug, which requires reductive activation of an aromatic nitro group before it becomes effective against TB bacteria.4 Pre-clinical studies have demonstrated that PA-824 has potent bactericidal and sterilizing effects against DS-TB and MDR-TB. PA-824 has also been shown to be active against latent TB bacteria.

 

Keywords: TB, bacteria, orphan, drug, access

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Increasing Access to HIV Treatment in Middle-income Countries: Key Data on Prices, Regulatory Status, Tariffs and the Intellectual Property Situation. WHO. (2014)

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The paper provides information on the prices paid by 20 middle-income countries for adult and paediatric formulations of antiretroviral treatments recommended by WHO. It links this information with an analysis of the intellectual property situation of the selected medicines taking into account existing license agreements as well as compulsory licenses, and includes data and general information on a number of other determinants of prices and availability of ARVs, including tariffs, markups and taxes, as well as the regulatory status. 

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