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ARTICLE | Clinical News

Truvada emtricitabine/tenofovir regulatory update

May 14, 2012 7:00 AM UTC

FDA's Antiviral Drugs Advisory Committee concluded the benefit-risk profile for Truvada emtricitabine/tenofovir supports the drug's use as pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection in uninfected adults. The panel voted 19-3 in favor of recommending approval of the drug for high-risk men who have sex with men and 19-2, with 1 abstention, in favor of recommending approval in serodiscordant heterosexual couples. For other individuals at risk of acquiring HIV through sexual activity, the panel voted 12-8, with 2 abstentions, in favor of Truvada as PrEP.

Panel members echoed the concerns of FDA briefing documents about inadequate adherence and the risk of resistance development. The panel recommended HIV testing at baseline and every few months thereafter should be part of Gilead's proposed REMS. ...