FDA Approves Drug to Reduce Risk of HIV Infection

The U.S. Food and Drug Administration (FDA) has granted approval for a drug intended to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and/or who may engage in sexual activity with HIV-infected partners. The drug, trade name Truvada™ (emtricitabine/tenofovir disoproxil fumarate), was approved on July 16. The same drug was previously approved for use with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.

Truvada™ is designed to be taken daily, and “to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk,” according to an FDA press release. Drug packaging will include a warning that only individuals who are confirmed to be HIV-negative should use Truvada™. The drug is contraindicated for individuals with unknown or positive HIV status.

The most common, serious side effects of Truvada™ include lactic acidosis (a buildup of acid in the blood) and liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat in the liver (steatosis).

As a condition of approval, the drug’s manufacturer, Gilead Sciences, Inc., must collect viral isolates from individuals who acquire HIV while taking Truvada™ and evaluate these isolates for the presence of resistance. The company must also collect data on pregnancy outcomes for women who become pregnant while taking Truvada™.

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