WASHINGTON, July 16 (UPI) -- The U.S. Food and Drug Administration said Monday it approved Truvada, the first drug that prevents HIV infection in people who have sex with infected partners.
Dr. Margaret A. Hamburg, commissioner of the FDA, said the administration previously approved Truvada to be used in combination with other anti-retroviral agents for the treatment of HIV-infected adults and children age 12 or older.
Truvada -- emtricitabine/tenofovir disoproxil fumarate -- is to be taken daily by uninfected individuals who are at high risk of being infected by human immunodeficiency virus, which causes AIDS, and who might engage in sexual activity with HIV-infected partners in combination with safer sex practices, Hamburg said.
A pre-exposure prophylaxis indication means Truvada is approved for use as part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling and regular HIV testing.
"Today's approval marks an important milestone in our fight against HIV," Hamburg said. "Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test and care for people living with the disease. New treatments, as well as prevention methods, are needed to fight the HIV epidemic in this country."
The Partners pre-exposure prophylaxis trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not.
The trial showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo, FDA officials said.
