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News From the Food and Drug Administration
December 5, 2001

New Drug for HIV-1 Infection

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JAMA. 2001;286(21):2660. doi:10.1001/jama.286.21.2660

The FDA has approved tenofovir disoproxil fumarate tablets (Viread, Gilead Sciences Inc, Foster City, Calif) in combination with other antiretroviral agents for the treatment of HIV-1 infection. Viread is a prodrug of tenofovir (nucleotide analog), which exhibits activity against HIV reverse transcriptase.

The indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in a controlled study of 24 weeks' duration and in a controlled, dose-ranging study of 48 weeks' duration. Treatment-experienced adults with evidence of HIV-1 viral replication despite ongoing antiretroviral therapy were randomized to receive either Viread or placebo in addition to their stable background regimen of antiretroviral agents. In both studies, the mean baseline CD4 cell count was approximately 410/µL, median baseline plasma HIV RNA was approximately 3500 copies/mL, and mean duration of prior HIV treatment was approximately 5 years.