(Justin Sullivan: Getty Images)

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.

You can read or listen to the interview here.

The FDA panel approved Truvada, an antiretroviral drug for use by healthy people to prevent HIV infection. (Justin Sullivan: Getty Images)

From AP:

A panel of federal health advisers has endorsed the first drug shown to prevent HIV infection in healthy people, clearing the way for a potentially landmark approval in the 30-year-old effort against the virus that causes AIDS.

In a series of votes, the Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-infected person. The FDA is not required to follow the panel’s advice, though it usually does. A final decision is expected by June 15.

Drugmaker Gilead Sciences Inc., of Foster City, already markets Truvada as a treatment for people who are infected with HIV.

Last July, 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.

You can read or listen to the interview here.