FDA Approves Lenacapavir for HIV Pre-Exposure Prophylaxis

The U.S. Food and Drug Administration (FDA) recently 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.

“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.

In the PURPOSE 1 and PURPOSE 2 studies, which formed the basis of the approval, lenacapavir for PrEP was studied in cisgender men and women, transgender men and women, and gender-diverse people who have sex with partners assigned male at birth. The FDA indication is for use in sexually active adults and adolescents who are at risk of acquiring HIV-1. Additional studies have already started enrollment—PURPOSE 3 (cisgender women in the U.S. who have sex with cisgender men); PURPOSE 4 (injection drug users); and PURPOSE 5 (Truvada for PrEP, which is a daily pill, vs. lenacapavir for PrEP, among key populations).