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News From the Food and Drug Administration
November 4, 1998

New Drug to Treat HIV/AIDS Approved

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JAMA. 1998;280(17):1472. doi:10.1001/jama.280.17.1472-JFD80010-2-1

The FDA has approved efavirenz (Sustiva, DuPont Pharmaceuticals, Wilmington, Del) for use in combination with other antiretroviral agents in the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-RNA levels and CD4 cell counts in controlled studies of up to 24 weeks in duration. At present, there are no results from controlled trials evaluating long-term suppression of HIV-RNA with efavirenz.

Resistant virus emerges rapidly when nonnucleoside reverse-transcriptase inhibitors are administered as monotherapy. The labeling warns, therefore, that efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen. Efavirenz therapy should always be initiated in combination with at least one other new antiretroviral agent to which the patient has not been previously exposed.