Gilead's Truvada approved for PrEP


SILVER SPRING, Md. — The Food and Drug Administration has approved a drug used to treat HIV for reducing the risk of HIV infection, the agency said Monday.

The FDA announced the approval of Gilead Sciences Truvada (emtricitabine and tenofovir disoproxil fumarate) in adults who don't have HIV but are at high risk of becoming infected, also known as pre-exposure prophylaxis, or PrEP. For the new indication, the drug is designed to be taken once per day and combined with safer sex practices such as "consistent and correct" condom use, risk-reduction counseling, regular HIV testing and treatment of any other sexually transmitted infections; the drug is not meant as a substitute for safer sex practices.

"In the 80s and early 90s, HIV was viewed as a life-threatening disease; in some parts of the world, it still is," FDA Division of Antiviral Products director Debra Birnkrant said. "Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time. But it is still better to prevent HIV than to treat a life-long infection of HIV."

The approval was based on two clinical trials showing that daily use of Truvada reduced the risk of HIV infection by 42% in gay and bisexual men and transgender women and by 75% in HIV-negative people with opposite-sex partners who were HIV-positive.

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