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FDA approves Truvada for PrEP
The FDA has approved combination emtricitabine plus tenofovir disproxil fumarate, combined with safer sex practices, to reduce the risk of acquiring HIV infection in adults at high-risk for HIV.
The combination pill (Truvada, Gilead) is the first agent to be approved for pre-exposure prophylaxis, according to a Gilead press release. Gilead will continue to work with the FDA to develop a Risk Evaluation and Mitigation Strategy.
Data from two large placebo-controlled trials, the Pre-Exposure Prophylaxis Initiative (iPrEx) trial and the Partners PrEP trial, were the basis of the FDA’s decision. In the iPrEx trial, the drug reduced the risk of acquiring HIV by 42%, and in the Partners PrEP trial, the drug reduced the risk of acquiring HIV by 75%.
In both studies, the most commonly reported adverse effects included headache, stomach discomfort and weight loss.
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This approval is a milestone in HIV prevention. This opens up an entirely new set of opportunities for preventing new infections. We have a package of proven and effective prevention strategies, including PrEP, that has the potential to turn the tide on the epidemic.
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With 50,000 new HIV infections in the United States each year, additional prevention methods are urgently needed. The CDC applauds the FDA’s decision to approve the use of Truvada (a combination of 300 mg of tenofovir and 200 mg of emtricitabine) to reduce the risk of acquiring HIV. We believe this is an important step that should help ensure that physicians and patients receive the detailed information and educational materials needed to most effectively use this prevention strategy.
If delivered effectively and targeted to those at highest risk, pre-exposure prophylaxis (PrEP) could play an important role in our response to the HIV epidemic. Strong research evidence indicates that PrEP, when used consistently, is safe and effective at reducing the risk of acquiring HIV sexually. Last year, the CDC provided interim guidance for gay and bisexual men who may be considering the use of PrEP, and soon will publish similar guidance for heterosexual men and women.
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The use of antiretroviral drugs to prevent HIV infection gives us an important new tool in an increasingly impressive battery of means of slowing the global epidemic. While this is unlikely to be appropriate for large populations, it almost certainly will have a more specific role in those who are unable to otherwise protect themselves from HIV exposure. Pre-exposure prophylaxis, along with the much larger role of treatment as prevention, is giving us optimism for the first time that the epidemic might someday be brought under control.