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FDA approves first new class of HIV drugs. Food and Drug Administration.


 The U.S. Food and Drug Administration (FDA) recently approved nevirapine (Viramune), a non-nucleoside reverse transcriptase inhibitor. This is the first approval for a new class of drugs that uses a different mechanism to stop HIV from replicating. The approval was based on several recent studies showing that nevirapine has a strong and lasting antiretroviral effect when used with combination therapy. However, earlier studies with nevirapine alone or in combination with one drug were not promising because of the rapid development of drug resistance. Boehringer Ingelheim Pharmaceuticals of Indianapolis took over the testing of the drug from Merck & Co. of Rahway, NJ. When nevirapine was combined with zidovudine (AZT) and didanosine (ddI), patients' CD4 counts rose significantly and viral load was reduced to below detectable levels. Although the results are impressive, more than 20 percent of the patients dropped out of the study, primarily because of the side effects. Some clinicians are wary of using the drug because of toxicity, since no survival or clinical data are available.
