FDA Committee Will Consider Approval of Truvada for HIV PrEP this Thursday

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On May 10, 2012, the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hear evidence regarding the use of the tenofovir/emtricitabine combination pill Truvada for pre-exposure prophylaxis (PrEP) to prevent HIV infection. Gilead Sciences requested approval of the expanded indication in December 2011.

A growing body of evidence shows that tenofovir, with or without emtricitabine, can prevent HIV acquisition if taken every day. The iPrEx study of gay and bisexual men (plus a small number of transgender women) and the Partners PrEP and TDF2 trials of heterosexual men and women showed that once-daily Truvada PrEP dramatically reduced the risk of infection. However, the Fem-PrEP study of heterosexual women was halted early due to lack of efficacy, as was an arm of the VOICE trial testing tenofovir alone. Further data presented at this year's Retrovirus conference (CROI 2012) indicated that adherence and adequate drug levels in the body are keys to PrEP's effectiveness.

While Truvada PrEP appears highly effective -- at least for well-selected, high-risk populations that use it as part of a comprehensive prevention strategy that also includes condoms and risk-reduction counseling -- advocates and public health officials have raised issues regarding difficulty of ensuring good adherence, long-term side effects (especially bone and kidney toxicity), drug resistance, and cost and access. Truvada has demonstrated long-term safety and efficacy as part of antiretroviral therapy for HIV treatment, but the risk/benefit balance is different when considering HIV negative people.

The FDA recently announced updated information about logistics and public participation at the committee hearing. Given the widespread interest and controversy surrounding Truvada for PrEP, the meeting has been extended in order to allow 2 hours for public comment. (The deadline for submitting written comments for advance distribution to committee members is already past.)

The hearing will start at 8:00 am at the FDA White Oak Campus
Building 31. The public comment period will be approximately 1:45 to 3:45 pm, with the meeting ending at 6:30 pm.

Full details about the advisory committee meeting, including the latest updates, is available at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm295927.htm.

Background material is now available online. The FDA plans to provide a free live webcast of the May 10 meeting as well as an archived recording; further information regarding the webcast will be made available at the same website.

5/8/12

Source

Food and Drug Administration (FDA). Updated Time, Agenda and Public Participation Information: May 10, 2012: Antiviral Drugs Advisory Committee Meeting Announcement. April 30, 2012.