The Food and Drug Administration has approved Truvada, the first drug shown to reduce the risk of HIV infection in people who are at high risk of acquiring HIV, the virus that causes AIDS.
Truvada was already approved as a medication for treatment of people already infected with HIV.
Truvada is to be taken twice a day in what is known as pre-exposure prophylaxis, or PrEP.
From the FDA’s press release:
As part of PrEP, HIV-uninfected individuals who are at high risk will take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus. A PrEP 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,” 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.”
Two large studies (both randomized, double-blind, placebo-controlled) showed Truvada’s efficacy in reducing the risk of HIV infection in uninfected individuals. In one trial, 2,499 HIV-negative men and transgender women who have sex with men and engage in high risk behavior for HIV infection, results showed Truvada reduced the risk of HIV infection by 42 percent.
In a study of 4,758 heterosexual couples where one partner was HIV-positive and the other was not, Truvada reduced the non-infected partner’s risk of becoming infected by 75 percent.
Last summer, KQED’s News Fix editor Jon Brooks interviewed Dr. Paul Volberding, co-director of the Center for AIDS Research at the University of California, San Francisco, about the research into Truvada up to that time. Volberding said results showed “the kind of effect we might expect from a very good vaccine.” They also discussed what populations might consider using Truvada as a prophylactic and whether giving healthy people a preventative drug might induce them to engage in riskier sexual activity.