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FDA Panel Endorses Truvada for Pre-Exposure Prophylaxis

Author: Mark Mascolini


12 May 2012

Truvada (coformulated tenofovir/emtricitabine) should be licensed for use as once-daily pre-exposure prophylaxis in men and women at high risk of sexually acquired HIV infection. That decision came from the Antiviral Drugs Advisory Committee of the US Food and Drug Administration (FDA) after 8.5 hours of deliberation.

Large majorities of committee members endorsed Truvada PrEP for men who have sex with men (19 versus 3) and for HIV-negative people with a regular HIV-positive partner (19 versus 2 with 1 abstention). A smaller majority (12 versus 8 with 2 abstentions) supported Truvada PrEP for "other individuals at risk for acquiring HIV through sexual activity."

Gilead Sciences, maker of Truvada, based its application on results of two placebo-controlled trials—iPrEx in men who have sex with men and Partners PrEP in HIV-discordant heterosexual African couples In their primary analyses, iPrEx found a 44% lower HIV acquisition risk with Truvada versus placebo, while Partners PrEP found a 75% lower risk with Truvada and a 67% lower risk with tenofovir alone.

Despite near-unanimity in its votes on PrEP for MSM and HIV-discordant couples, the FDA advisors struggled in recommending whether restrictions should apply to Truvada PrEP prescriptions and how closely clinicians should monitor PrEP users for the side effects sometimes seen with tenofovir.

Panelists agreed that everyone prescribed PrEP must have a negative HIV test, but how often they need confirmatory negative tests remains unclear. Likewise, how often and in what manner people taking Truvada PrEP should be monitored for kidney function and bone mineral density seemed hard to reckon. Committee members noted the difficulty in striking a balance between protecting PrEP users with the right tests and not making testing so burdensome that at-risk people turn away from the strategy.

In a premeeting briefing document (available at the link below), the FDA advised that “regular HIV testing, adherence and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP.”

“If physicians prescribe and individuals utilize [Truvada] in the manner described for PrEP, in combination with other strategies to prevent HIV infection,” ” the FDA stated, “the individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment with a three-drug antiretroviral regimen. That regimen, in line with current treatment guidelines for HIV-infected treatment-naive patients, will almost certainly contain [Truvada].”

For the FDA briefing document on Truvada PrEP

For the Gilead Sciences briefing document on Truvada PrEP