On June 18, the U.S. Food and Drug Administration (FDA) approved the first medicine to prevent HIV that only has to be taken twice a year. People who are at high risk for HIV can now take the injection—called lenacapavir and sold as Yeztugo—just once every six months.
The approval is a milestone in the fight against HIV and could transform the epidemic. While anti-HIV drug treatments have helped millions of people suppress the virus to undetectable levels so that they don’t spread it to others—and have also allowed people who are HIV-negative to maintain their status when used to prevent infection—a regimen of daily pills means that compliance, and therefore effectiveness, is often not as strong as it should be.
In two studies, scientists at Gilead, which developed lenacapavir, showed that the drug was 96% effective at protecting cisgender women from becoming HIV positive as compared to daily oral pills (called PrEP, short for pre-exposure prophylaxis). In men who have sex with men and gender-diverse people, the drug was 100% effective.
Read More: ‘This is About Children’s Lives’: Gavi’s CEO Makes the Case for Funding the Global Vaccine Alliance
“Lenacapavir used by itself for prevention is a huge breakthrough,” says Dr. David Ho, professor of microbiology, immunology, and medicine at Columbia University who pioneered combining anti-HIV drugs to suppress the virus and its ability to mutate to become resistant to treatment. “Its potential is great in curtailing the epidemic.”
But advocacy groups and global AIDS organizations raise concerns about whether that potential will be fully realized, given recent cuts to U.S.-supported programs for HIV treatment and prevention around the world.
From treatment to prevention
Lenacapavir was approved by the FDA in 2022 to treat people with HIV whose virus has become resistant to other antiviral drugs. As they were developing that treatment, Gilead’s scientists noticed that lenacapavir had two important…
