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U.S. Department of Health and Human Services


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Questions and Answers on Emtricitabine 200 mg/Tenofovir Disoproxil (marketed as Truvada)

Q. What is Truvada being approved for?

A. Today FDA approved Truvada (emtricitabine/tenofovir disoproxil fumarate) for use once daily for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk.

Truvada is 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. 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.

In 2004, FDA approved Truvada in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and in 2011 expanded this indication to include the treatment of pediatric patients 12 years of age and older.

Q. What data did FDA review to approve this indication?

A. Clinical trial data to support approval of Truvada for a PrEP indication was derived mainly from the iPrEx trial, sponsored by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAIDS), which studied Truvada for PrEP in men who have sex with men (MSM) and transgender women who have sex with men, and the Partners PrEP trial, sponsored by the University of Washington, which studied Truvada for PrEP in heterosexual couples where one partner is HIV-infected and the other is not (serodiscordant couples). We also reviewed safety data from the CDC 4323 trial conducted in 400 U.S. MSM, as well as top-line summaries and available abstracts from other completed or ongoing trials.

The iPrEx trial results showed taking Truvada daily in combination with other preventive measures reduced the risk of sexually acquiring HIV infection by 42% compared to placebo. In the Partners PrEP trial, Truvada reduced the risk of sexually acquiring HIV infection by 75% compared to placebo.

Q. When will Truvada be available to individuals for use as PrEP?

A. Truvada is currently available on the U.S. market to treat patients already infected with HIV. With today’s approval, Gilead can legally market Truvada for PrEP.

Q. What elements of the product label will help ensure Truvada for PrEP is used appropriately?

A. The revised product label for Truvada contains:

  • Additional language to the BOXED WARNING alerting patients and health care professionals that patients must have a negative HIV test before receiving the drug and throughout use for PrEP.
  • Detailed information in the INDICATIONS AND USAGE section outlining factors that may be considered to determine if an uninfected individual is at high risk.
  • A new CONTRAINDICATION (warning against using) for using Truvada for PrEP in HIV-infected individuals or individuals with unknown HIV status.
  • Added language to the WARNINGS AND PRECAUTIONS section describing how Truvada for PrEP should be used as part of a comprehensive HIV management strategy and the importance of strict adherence to the dosing regimen.

Q. Is FDA certain that the REMS will help ensure the safe and appropriate use of Truvada for PrEP? How does FDA know?

A. The evaluation of the REMS at the specified intervals will help determine its effectiveness and what, if any, changes need to be made to make the REMS more effective.