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11/1/04
Because AIDS drugs are so expensive and AIDS is a problem in some of the poorest parts of the world, there's been a push to produce more generic drugs. The situation is so dire that generic drugs are recommended in many poorer countries even without information on the generics' safety and effectiveness. A group of researchers in France and Cameroon followed patients taking a generic combination therapy to see how they did.
What the researchers wanted to know: Are generic AIDS drugs safe and effective?
What they did: As part of a project to get antiretroviral drugs out, the researchers followed 60 Cameroonians for 24 weeks. All were patients at one of two hospitals in Yaoundè all were HIV-positive, and all but five had AIDS. Every day, each patient took one tablet twice a day, containing a combination of three generic drugs (nevirapine, stavudine, and lamivudine), a very common treatment in African countries. This sort of drug is considered a particularly important tool for combating AIDS in developing countries because it is inexpensive and requires fewer doses a day than treatment regimens where the different drugs are separate. Patients came in every two weeks for the first eight weeks of the study, then every four weeks, for a physical exam. At some visits, the patients had blood taken for viral load measurements and and immune cell counts, and to test the levels of the drugs in their blood.
What they found: The generic drugs had similar effects and seemed to be tolerated as well as other drugs have been in other trials.
What the study means to you: Generic drugs may indeed be useful for controlling the AIDS epidemic in Africa.
Caveats: This is not a randomized double-blind controlled clinical trial; all the patients took the same drugs, and everyone knew what they were taking. The researchers compared these results with other trials to conclude that the generic drugs seemed to work OK, so the conclusions aren't as powerful as if they'd compared the combination of generics with other treatment regimens in the same trial. Also, 24 weeks is a fairly short time, and patients might have developed resistance to the drugs over a longer study time.
Find out more: HIV InSite is a University of CaliforniaSan Francisco website full of AIDS news and information.
Read the article: Laurent, C., et al. "Effectiveness and Safety of a Generic Fixed-Dose Combination of Nevirapine, Stavudine, and Lamivudine in HIV-1-Infected Adults in Cameroon: Open-Label Multicentre Trial." The Lancet. July 3, 2004, Vol. 364, pp. 29-34.
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