CDC Recommends New Injectable HIV PrEP

Cross-posted from: CDC | NCHHSTP

Twice-a-year injectable lenacapavir is a highly recommended, additional option for HIV prevention and a significant step forward for the 2.2 million Americans that could benefit from PrEP.

Dear Colleague,

Today, CDC published new Clinical Recommendations for twice-a-year injectable lenacapavir as an additional option for HIV prevention in the United States. The U.S. Food and Drug Administration approved injectable lenacapavir, a prescribed medication, for HIV pre-exposure prophylaxis (PrEP) in June 2025. This is a significant step forward in expanding prevention options and reflects decades of research, partnership, and commitment to ending the HIV epidemic.

CDC has reviewed and graded the evidence on lenacapavir as PrEP from two clinical trials, which demonstrated strong efficacy in preventing HIV infection among both females and males and found no serious safety concerns. On the basis of a high certainty of evidence for its efficacy and safety derived from the agency's analysis, CDC strongly recommends lenacapavir, administered every six months as a subcutaneous injection, for HIV PrEP in all people weighing at least 35 kg who would benefit.

The Clinical Recommendations for lenacapavir are an addition to CDC's current Clinical Guidance for PrEP which also recommends daily oral pills or injectable cabotegravir, which is administered every two months. All FDA-approved PrEP options are highly effective in preventing HIV when taken as prescribed.

CDC recommends health care providers inform all sexually active adults and adolescents about proven options for PrEP and prescribe PrEP to anyone who requests it. The addition of lenacapavir provides another powerful option in HIV prevention. Because lenacapavir only needs to be administered every six months, it may help some people overcome challenges with adherence or more regular health care visits associated with other existing PrEP options.

This milestone would not have been possible without the tireless efforts of our partners -- federal, academic, community-based, and clinical -- who lead and help generate the evidence-based research and programs.

According to the most recent CDC estimates, more than 31,000 people acquire HIV in the United States each year. The FDA approved the first HIV PrEP in 2012, and PrEP has become a vital part of U.S. HIV prevention efforts. Combined with HIV testing and effective treatment, PrEP has contributed to significant reductions in new HIV infections. Reaching people with more options for PrEP, including lenacapavir, will further strengthen national efforts and accelerate progress toward ending the HIV epidemic.

CDC estimatesExit Disclaimer 2.2 million Americans could benefit from PrEP and is currently working to update estimates of current PrEP coverage in the United States. Thank you for helping us raise the visibility of this new prevention option as we continue to work together to maximize the impact of all available strategies for preventing HIV.

Sincerely,
/Robyn Fanfair/ 
 

Robyn Neblett Fanfair, MD, MPH
Captain, USPHS
Director
Division of HIV Prevention
National Center for HIV, Viral Hepatitis, STD, and TB Prevention
Centers for Disease Control and Prevention