­Statement from amfAR on FDA Approval of Lenacapavir for HIV Pre-Exposure Prophylaxis

amfAR recognizes the transformative potential of lenacapavir for PrEP to dramatically reduce new HIV infections and change the trajectory of the epidemic

NEW YORK, June 18, 2025 — The U.S. Food and Drug Administration (FDA) announced Thursday that it has approved the antiretroviral drug lenacapavir for use as HIV pre-exposure prophylaxis (PrEP). Twice-annual injection of lenacapavir was shown to be 100% effective at preventing HIV transmission in one clinical trial and was named Science’s Breakthrough of the Year in 2024.

amfAR is encouraged by this first and necessary step toward realizing lenacapavir’s revolutionary potential. It is now of the utmost importance that lenacapavir be priced and distributed equitably, so that it can be made available to all who need it.

“PrEP is one of the most indispensable tools we have for ending the HIV epidemic. Having the option of a twice-annual shot, rather than relying on a daily pill, will make long-term adherence to PrEP much easier for many,” amfAR Chief Executive Officer Kevin Robert Frost said. “But this remarkable drug will only be as effective as it is accessible and affordable. amfAR calls on Gilead Sciences and the U.S. government to do everything in their power to make sure as many people who want lenacapavir can get it.”

Recent research shows just how important PrEP is. Data published in The Lancet HIV show states with high oral PrEP coverage have seen a 38% decrease in new HIV diagnoses over 10 years, compared to a 27% increase in diagnoses in states with low oral PrEP coverage over the same period. PrEP usage in the U.S. is woefully insufficient. As of 2022, the Centers for Disease Control and Prevention (CDC) indicated there were 1.2 million Americans who could benefit from PrEP but just over 400,000, or 36%, were actually accessing it. Inconsistent adherence to a daily oral PrEP regimen remains a barrier to its long-term efficacy, which is what makes a long-acting injectable option such a promising advancement.

Lenacapavir for PrEP is designated for use by cisgender men and women, transgender men and women, and gender-diverse people who have sex with partners assigned male at birth.

About amfAR
amfAR, The Foundation for AIDS Research, is one of the world’s leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and advocacy. Since 1985, amfAR raised nearly $950 million in support of its programs and has awarded more than 3,800 grants to research teams worldwide. Learn more at www.amfAR.org

Media Contact:
Robert Kessler, Program Communications Manager
(212) 806-1602
robert.kessler@amfar.org

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