Overview

• The State Department said PEPFAR will purchase the doses and coordinate distribution with the Global Fund and national programs, while declining to disclose the U.S. investment.
• Implementation targets low- and middle-income countries and will prioritize pregnant and breastfeeding women to reduce mother-to-child transmission.
• Lenacapavir is a twice‑yearly injectable for HIV prevention that showed near‑complete protection in trials and has approvals from the FDA, WHO and EMA.
• Gilead has royalty‑free licenses with six generic manufacturers for 120 countries and will provide no‑profit supply until generics can meet demand.
• Plans include regulatory filings for PrEP in 18 countries using WHO collaborative registration pathways, and officials signaled pricing could be as low as about $100 per person per year, with timelines and costs still being finalized.