DDT July 08
How developing country concerns need to be part of drug development plans
Although the majority of people infected with HIV/AIDS live in the developing world, there are often long delays between the registration of a new antiretroviral drug in the West and its inclusion in national healthcare systems in developing countries.
For example, the World Health Organization (WHO) included tenofovir in first-line antiretroviral therapy for resource-limited settings in 2006, five years after the FDA registered it. As of May 2008, only three African countries have included tenofovir in their guidelines for first-line regimens (Namibia, Lesotho and Zambia).
Why does it take so long to integrate new life-saving drugs in treatment guidelines of developing countries? Affordability and timely drug registration are recognized issues, but another limiting factor that is much more poorly recognized is the lack of relevant studies providing evidence for added value above existing treatment algorithms.
MSF and others have argued that this is intrinsically linked to the lack of profitability in resource limited settings: HIV-infected populations differ between developed and developing countries, the latter including significant numbers of children, women of child-bearing age and people coinfected with tuberculosis, malaria and other infectious diseases.
This paper focuses on four antiretroviral drugs that are advanced in development or that have been recently approved to provide an analysis of to what extent current research and development of HIV drugs appropriately addresses the needs of developing countries.
Three drugs, maraviroc, raltegravir and etravirine, have been approved by the FDA since mid-2007, while the fourth drug under discussion here – rilpivirine – is currently the most advanced drug in the HIV pipeline.
This is an extract from an article that appeared in Drug Development Today, Volume 13, July 2008
