Overview

• Lenacapavir, marketed as Yeztugo, won FDA approval on June 18, 2025, enabling two injections per year for pre-exposure prophylaxis against HIV.
• Clinical trials involving over 4,000 participants showed 100% efficacy in preventing HIV among women and adolescent girls in sub-Saharan Africa and 99.9% prevention in a diverse global cohort.
• Gilead plans to set Yeztugo’s list price at roughly $28,218 annually before insurance, mirroring existing PrEP costs despite analyses indicating production could cost as little as $25 per person each year.
• The company has granted royalty-free licenses to six generic manufacturers to supply low-cost versions in 120 low-income countries and pledged up to 2 million doses at no profit before generics launch.
• Health experts warn that Trump administration cuts to HIV prevention and proposed Medicaid funding reductions could undermine access, especially for low-income and marginalized groups.