12:00 AM
May 14, 2012
 |  BioCentury  |  Regulation

Risky business

Next issue for Gilead's Truvada to prevent HIV: What REMS will FDA require

Last week's positive FDA panel vote sets the stage for approval of the first drug to prevent HIV infection. The onus will now be on the agency and Gilead Sciences Inc. to design and implement a postmarketing education and surveillance program for use of Truvada emtricitabine/tenofovir that will provide high-risk individuals with access to the drug without encouraging risky behavior.

The Antiviral Drugs Advisory Committee voted 19-3 in favor of approval of the Truvada for high-risk men who have sex with men. It voted 19-2, with one abstention, in favor of approval in serodiscordant heterosexual couples.

For other individuals at risk of acquiring HIV through sexual activity, the panel voted 12-8, with two abstentions, in favor of the drug.

The committee stressed the importance of baseline HIV testing to minimize the risks of drug resistance, additional studies to evaluate real-world effectiveness, and the need for aggressive outreach to inform physicians and patients about proper use of the drug.

Truvada is a fixed-dose combination of Viread tenofovir, a nucleotide analog reverse transcriptase inhibitor, and Emtriva emtricitabine, a nucleoside reverse transcriptase inhibitor. FDA approved Truvada in 2004 to treat HIV in combination with at least one other antiretroviral agent.

FDA, members of the panel and even most speakers who came to the meeting to protest approval of the drug agreed Truvada was effective in the two primary studies used to support Gilead's sNDA for prophylactic use.

In the Phase III iPrEx trial, which was sponsored by the National Institutes of Health, once-daily Truvada met the primary endpoint by decreasing the incidence of HIV infection by 42% compared to placebo in 2,499 HIV-seronegative men who have sex with men (95% CI: 22-63%).

In the Phase III Partners PrEP trial, the drug reduced the incidence of HIV...

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