WASHINGTON — The U.S. Food and Drug Administration on Monday approved Truvada, the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection, or who may engage in sexual activity with HIV-infected partners.
Truvada was previously approved by the FDA to be used in combination with other anti-retroviral agents for the treatment of HIV-infected adults and children 12 years or older.
“Today’s approval marks an important milestone in our fight against HIV,” said FDA Commissioner Margaret A. Hamburg, M.D.
“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,” Hamburg said.
In a clinical trial involving 2,499 HIV-negative men or transgender women who have sex with men and with evidence of high risk behavior for HIV infection, Truvada was effective in reducing the risk of HIV infection by 42 percent compared with placebo.
In a second clinical trial of 4,758 heterosexual couples where one partner was HIV-infected and the other was not, Truvada reduced the risk of becoming infected by 75 percent compared with placebo.
The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss.
Full details on Truvada and the clinical trials are available via the FDA.