The FDA has approved a single-pill combination drug to reduce the chance of acquiring HIV among people at high risk for infection with the virus.
In two large clinical trials, the combination of tenofovir and emtricitabine, marketed as Truvada and taken daily, reduced the rate of infection among men who have sex with men and in heterosexuals, the agency noted in announcing the approval.
While anti-HIV drugs have been used for years to prevent infection of infants born to HIV-positive mothers, Truvada is the first indicated specifically for so-called pre-exposure prophylaxis, or PrEP, the agency said.
It was previously approved for treatment of HIV in adults and children 12 or older, and an FDA advisory panel endorsed the new indication in May.
The new indication means the drug combination is “part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing,” the FDA said.
The approval is “an important milestone in our fight against HIV,” said FDA Commissioner Margaret Hamburg, MD.
Hamburg noted in a statement that about 50,000 Americans are diagnosed with HIV infection yearly. “New treatments as well as prevention methods are needed to fight the HIV epidemic in this country,” she added.