The U.S. Food and Drug Administration has approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection 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 to reduce the risk of sexually-acquired HIV infection in adults at high risk.
The FDA previously approved Truvada to be used in combination with other antiretroviral agents for the treatment of HIV-infected adults and children 12 years or older.
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.
“This 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.”
As a part of this action, the FDA is strengthening Truvada?s Boxed Warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use. The drug is contraindicated for PrEP in individuals with unknown or positive HIV status. The FDA strongly recommends against such use.
No new side effects were identified in the clinical trials evaluating Truvada for the PrEP indication. The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Serious adverse events in general, as well as those specifically related to kidney or bone toxicity, were uncommon.
Source: U.S. Food and Drug Administration, USA