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FDA Approves Truvada for PrEP

, by Reilly O'Neal

(Photo: Gilead Sciences, Inc.)

Today the U.S. Food and Drug Administration approved the antiretroviral drug Truvada to be taken by HIV-negative people to prevent HIV infection—a prevention strategy known as pre-exposure prophylaxis, or PrEP. (View the agency’s press release here.)

In clinical trials of PrEP to date, the drug reduced HIV infection risk by up to 92% when taken as directed and as part of a comprehensive HIV-prevention package including condoms, safer sex counseling, and HIV testing.

“Today’s decision by the FDA heralds a new era in HIV prevention—one with great promise for expanded access to HIV testing and prevention counseling and support,” said San Francisco AIDS Foundation CEO Neil Giuliano in a press release. “The approval paves the way for increased work with the federal government and Gilead Sciences to ensure they realize the incredible impact they can now have to get Truvada to the communities that stand to benefit most, especially gay men and people of color.”

With an estimated 50,000 people newly infected with HIV every year in the United States, the development—and delivery—of safe and effective new HIV prevention approaches is vital to ending the HIV/AIDS epidemic. “Now the hard work begins to ensure that health care providers, clinics, and our community know how and when to use Truvada—and to ensure that price and delivery systems are never a barrier to access for anyone who stands to benefit from it,” said James Loduca, the foundation’s vice president of public affairs. (Read the full press release here.)

Studies of PrEP are ongoing and many questions remain about how best to use this new HIV prevention tool: How do we ensure that people use PrEP correctly—and safely—in the real world? How do we get it to the populations that need it most? And who will pay for PrEP? These and other key questions will be discussed at the 19th International AIDS Conference (AIDS 2012), starting July 22 in Washington, D.C.

Stay tuned for BETA’s upcoming in-depth feature on PrEP and our coverage of all things PrEP at AIDS 2012.  

Reilly O’Neal is a freelance writer and former editor of BETA.

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