A milestone in HIV prevention

17th July 2012

FDA approves first drug for reducing the risk of sexually acquired HIV infection

Yesterday, the U.S. Food and Drug Administration approved Truvada - the first drug to reduce the risk of HIV infection in uninfected individuals at high risk of HIV and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices.

The FDA had previously approved Truvada for people already infected with HIV, to be used in combination with other antiretroviral agents.

"This approval marks an important milestone in our fight against HIV," said FDA Commissioner Margaret 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’s safety and efficacy for PrEP were demonstrated in two large, randomised, double-blind, placebo-controlled clinical trials. The Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not (serodiscordant couples). The trial evaluated the efficacy and safety of Truvada and tenofovir versus placebo in preventing HIV in the uninfected male or female partner. Results showed Truvada reduced the risk of becoming infected by 75 percent compared with placebo.

No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss, but serious adverse events in general were uncommon.

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