FDA approves HIV-prevention drug Truvada in the US

17 Jul 2012

The U.S. Food and Drug Administration (FDA) has approved a drug called Truvada, the first drug that’s ever been approved to reduce the risk of sexually acquired HIV infection.

Taken daily, Truvada is aimed at individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners.

The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children who were aged 12 or older.

However, the FDA emphasised that the drug needs to be taken in combination with overall safer sex practices.

HIV epidemic

“Today’s approval marks an important milestone in our fight against HIV,” said FDA commissioner Margaret A Hamburg, MD, in an official statement.

“Every year, about 50,000 US 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,” she said.

The FDA said 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.

The US organisation said it will also be strengthening Truvada’s boxed warning to alert healthcare professionals and uninfected individuals that Truvada must only be used by those who are confirmed to be HIV negative prior to the drug being prescribed and at least every three months during its usage.

Clinical trials before approving the drug

The FDA said Truvada’s safety and efficacy were demonstrated in two large, randomised, double-blind, placebo-controlled clinical trials.

Firstly, the iPrEx trial evaluated Truvada in 2,499 HIV-negative men or transgender women who have sex with men and who present evidence of high risk behaviour for HIV infection, such as inconsistent or no condom use during sex with a partner of positive or unknown HIV status, a high number of sex partners, and who exchange of sex for commodities.

The FDA said the results showed Truvada was effective in reducing the risk of HIV infection by 42pc compared with placebo in this population.

Meanwhile, the Partners PrEP trial was conducted in 4,758 heterosexual couples where one partner was HIV-infected and the other was not.

The FDA said the trial evaluated the efficacy and safety of Truvada versus the placebo in preventing HIV infection in the uninfected male or female partner.

The results of the study showed Truvada reduced the risk of becoming infected by 75pc compared with placebo.

As a condition of approval, the FDA said Truvada’s manufacturer, Gilead Sciences, will be required to collect viral isolates from individuals who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance.

Additionally, the company will be required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada.

HIV virus image via Shutterstock

Carmel Doyle was a long-time reporter with Silicon Republic