Medicins Sans Frontieres Announces Results of Study of Generic Fixed-Dose Combination Antiretrovirals in Developing Countries
July 15, 2004
Medicins sans Frontieres on Wednesday at the XV International AIDS Conference presented the results of the first large-scale study of generic fixed-dose combination antiretroviral drugs in developing countries, the New York Times reports. The study, which expanded on a "much smaller" study that was published in the July 3 issue of the Lancet, was conducted in 21 countries using a generic FDC containing lamivudine, nevirapine and stavudine. Indian drug makers Cipla and Ranbaxy Laboratories each make a version of the drug (Altman, New York Times, 7/15). Patients can take the generic FDC as one pill twice a day, and it costs about $140 per person per year. A regimen of the same three drugs purchased separately from patent holders GlaxoSmithKline, Bristol-Myers Squibb and Boehringer-Ingelheim requires six pills a day and costs about $562 per patient per year (Kaiser Daily HIV/AIDS Report, 7/2). MSF since 2002 has treated a total of 12,058 HIV-positive adults with antiretrovirals, and 6,861 of them received FDCs, according to Dr. Alexandra Calmy, an HIV/AIDS adviser for MSF. Of the patients who received FDCs, 51 of them had to change medicines because of side effects from one or more of the drugs contained within the FDC; patients who switched to a new regimen had to take 13 or more pills daily, according to the Times. MSF found that the one-year survival probability was 82.4% among recipients of FDCs, Calmy said, according to the Times. In addition, CD4+ cell counts among FDC recipients increased by an average of 137 cells/mm3 per year. However, FDCs failed to work in 12% of HIV-positive people in a subset of 477 people, according to the study, Times reports. Calmy said that the results offered a "very robust outcome, and the findings are important for the Global Fund [to Fight AIDS, Tuberculosis and Malaria] and other groups that are recommending" FDCs (New York Times, 7/15).
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