In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved the first HIV prevention treatment requiring just two doses per year. The injectable drug, lenacapavir, branded as Yeztugo, offers a new option for people at high risk of HIV infection and could dramatically alter the landscape of HIV prevention globally.
Developed by biopharmaceutical company Gilead Sciences, lenacapavir was shown in clinical trials to be 100% effective among men who have sex with men and gender-diverse individuals, and 96% effective among cisgender women—outperforming daily oral pre-exposure prophylaxis (PrEP) pills in terms of adherence and impact.
“This is a huge breakthrough,” said Dr. David Ho, a pioneer in HIV treatment research at Columbia University. “Lenacapavir’s long-acting protection has enormous potential in curbing the epidemic.”
The FDA had already approved lenacapavir in 2022 for treating drug-resistant HIV. Its transition from treatment to prevention was based on two unique properties: its ability to remain in the body for extended periods and its mechanism for blocking the virus’s replication process.
Challenges to Global Access
Despite its promise, concerns are mounting over equitable access. Advocacy groups warn that funding cuts to major U.S.-backed programs such as PEPFAR and USAID could hinder global distribution—particularly in low- and middle-income countries where HIV remains widespread.
“We just built the best plane in the world, but unfortunately tore up all the runways,” said Kevin Frost, CEO of amfAR. “Without proper infrastructure, lenacapavir’s global rollout may be severely limited.”
Gilead has struck royalty-free licensing deals with six generic manufacturers to produce the drug for 120 low- and middle-income countries. However, experts say real-world impact will depend on overcoming logistical hurdles like clinic access, HIV testing before each injection, and cost.
Long-Term Implications for HIV Research
Lenacapavir’s success also raises ethical questions about ongoing vaccine development. Because the drug is so effective, placing individuals in placebo groups in vaccine trials may no longer be feasible.
“It’s not a vaccine, but it mimics one in terms of efficacy,” Dr. Ho noted. “This could shift focus away from vaccine research, at least in the short term.”
Looking Ahead
The Global Fund aims to reach two million more people with HIV prevention tools over the next three years and sees lenacapavir as a key component. Gilead is also working on a once-yearly version and exploring a self-injectable form, which could make the drug more accessible to underserved populations.
As nations weigh the costs, infrastructure needs, and health equity concerns, experts say lenacapavir’s approval marks both a scientific triumph and a policy test. Whether it reshapes the global epidemic may depend not on the drug’s power, but on the world’s will to deliver it.