In 2022, the Food and Drug Administration (FDA), along with other health organizations, approved the drug lenacapavir as a groundbreaking HIV/AIDS treatment. The FDA, as of June 18, 2025, has now approved the drug as an HIV preventive, or HIV pre-exposure prophylaxis (PrEP).
In a 2024 clinical trial, lenacapavir had a 100 percent success rate at preventing HIV transmission with only two injections per year.
“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, the CEO of the American Foundation for AIDS Research (amfAR) in a press release. “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 ...