CDC Statement on FDA Approval of Drug for HIV Prevention

Today the U.S. Food and Drug Administration (FDA) announced it has approved the drug combination of 300 mg tenofovir and 200 mg emtricitabine (TDF/FTC; brand name Truvada) for daily use by uninfected adults to help prevent the sexual acquisition of HIV. TDF/FTC has been commercially available as an HIV treatment since 2004. This is the first time any drugs have been approved for the prevention of sexually acquired HIV infection.

Below is a statement for attribution to Dr. Kevin Fenton, Director, CDC National Center for HIV/AIDS, Viral Hepatitis, STD & TB Prevention:

With 50,000 new HIV infections in the United States each year, additional prevention methods are urgently needed. The Centers for Disease Control and Prevention applauds the U.S. Food and Drug Administration’s decision to approve the use of Truvada (a combination of 300 milligrams of tenofovir and 200 milligrams of emtricitabine) to reduce the risk of acquiring HIV. We believe this is an important step that should help ensure that physicians and patients receive the detailed information and educational materials needed to most effectively use this prevention strategy.

If delivered effectively and targeted to those at highest risk, pre-exposure prophylaxis (PrEP) could play an important role in our response to the HIV epidemic. Strong research evidence indicates that PrEP, when used consistently, is safe and effective at reducing the risk of acquiring HIV sexually. Last year, the Centers for Disease Control and Prevention provided interim guidance for gay and bisexual men who may be considering the use of PrEP, and soon will publish similar guidance for heterosexual men and women. Key considerations for the use of PrEP include:

• PrEP will not be right for everyone, but for some individuals at high risk for HIV infection, it may provide an important additional prevention tool.
• PrEP must be used consistently to be effective, as the level of protection has been shown to be closely related to levels of medication adherence.
• PrEP should not be thought of a stand-alone solution. It should be provided as part of a comprehensive package of prevention services, including counseling regarding risk reduction and the importance of adherence to daily doses of PrEP medication, ready access to condoms, and diagnosis and treatment of sexually transmitted infections.
• Individuals using PrEP must receive initial and regular HIV testing to confirm they do not have HIV infection, and be monitored for potential side effects.

CDC is also leading the development of more detailed U.S. Public Health Service guidelines on the use of PrEP as part of comprehensive HIV prevention programs, which we anticipate will be published later this year.

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U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES