WASHINGTON, June 23, 2025 – The U.S. Food and Drug Administration has approved lenacapavir as the world’s first twice-yearly injectable for HIV prevention—a landmark moment in the fight against one of the globe’s most enduring public health challenges.
The drug, developed as a form of pre-exposure prophylaxis (PrEP), requires just two injections a year and has demonstrated near-perfect efficacy in major clinical trials. The World Health Organization hailed the decision as a “critical milestone” in the global effort to expand HIV prevention options—especially for people who struggle with daily or monthly medication routines.
Clinical impact in Africa
Lenacapavir’s promise was most clearly seen in two large-scale trials in sub-Saharan Africa. These studies focused on adolescent girls and young women—a group disproportionately affected by new HIV infections. In the trials, the injectable successfully prevented almost all new cases of HIV when administered on schedule.
Why it matters
PrEP has revolutionized HIV prevention in recent years, but its effectiveness has been limited by challenges with adherence. Daily oral pills and even monthly regimens can be hard to maintain, especially in under-resourced settings. Lenacapavir’s long-acting formula could dramatically reduce infection rates—if access is ensured across populations who need it most.
Access and equity questions
While the science is promising, global health leaders warn that affordability and distribution remain major hurdles. WHO officials emphasized that many low- and middle-income countries lack the systems—and financing—needed to deploy long-acting PrEP at scale. They called for international cooperation to ensure the innovation doesn’t stay limited to wealthier nations.
Next steps
Global health agencies are now working with Gilead Sciences, the drug’s manufacturer, to secure broader access agreements. WHO plans to issue updated guidelines on the use of injectable PrEP later this year and will be convening partner countries to align on cost-sharing strategies and delivery logistics.