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