By Bunmi Yekini
The U.S. Food and Drug Administration (FDA) announced Thursday that it has approved the antiretroviral drug lenacapavir for use as pre-exposure prophylaxis (PrEP) against HIV. In a clinical trial, a twice-yearly injection of lenacapavir was shown to be 100% effective at preventing HIV transmission — an outcome that led Science magazine to name it “Breakthrough of the Year” in 2024.
HIV research and policy leaders welcomed the news as a historic step toward making PrEP easier and more effective for those at risk.
“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,” said Kevin Robert Frost, Chief Executive Officer of amfAR.
He stressed that equitable access will determine the drug’s impact.
“But this remarkable drug will only be as effective as it is accessible and affordable,” Frost added. “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.”
Data published in The Lancet HIV underscore PrEP’s proven role in reducing HIV diagnoses. States with high oral PrEP coverage saw new HIV infections drop by 38% over a 10-year period, while states with low coverage saw a 27% increase. Despite its success, PrEP uptake in the U.S. remains inadequate — just 36% of the estimated 1.2 million Americans who could benefit were receiving oral PrEP as of 2022, according to the Centers for Disease Control and Prevention (CDC).
Lenacapavir is approved for use by cisgender men and women, transgender men and women, and gender-diverse people who have sex with partners assigned male at birth, marking a promising new chapter in HIV prevention.