Overview

• The FDA cleared lenacapavir (Yeztugo) on June 18, 2025, marking the first twice-yearly injection authorized to prevent HIV infection.
• Clinical trials showed nearly 100% efficacy, surpassing daily PrEP pills and offering only biannual clinic visits to maintain protection.
• Gilead Sciences set a U.S. list price of $28,218 per year, despite research indicating production costs could be as low as $25–40 per person annually.
• Gilead has agreements with six generic manufacturers to supply low-cost versions to 120 low-income countries and will provide two million doses at no profit until generics launch.
• Cuts to domestic and global HIV prevention funding and gaps in healthcare infrastructure raise concerns that many at risk may still lack access to the new shot.