On Monday, the U.S. Food and Drug Administration (FDA) approved Truvada, the first drug to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection.
Truvada was previously approved by the FDA to be used in combination with other antiretroviral agents for the treatment of HIV-positive 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. "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."
Truvada was found to lower the risk of infection by 42 percent compared with placebo in a clinical trial of 2,499 HIV-negative men or transgender women who are at risk of contracting HIV. In a second trial involving 4,758 heterosexual couples where one partner was HIV-positive and the other was not (serodiscordant couples), Truvada reduced the risk of becoming infected by 75 percent compared with placebo.
The FDA strongly recommends against individuals with unknown or positive HIV status from using Truvada in this capacity.