Overview

• The State Department said PEPFAR will purchase lenacapavir and work with the Global Fund and national governments on distribution, prioritizing pregnant and breastfeeding women.
• Lenacapavir is a twice‑yearly injectable PrEP that showed near‑100% protection in trials and has regulatory backing from the FDA, WHO and EMA.
• Gilead committed to provide the drug at no profit as a bridge to royalty‑free generic production by six manufacturers for 120 resource‑limited countries.
• The company plans regulatory filings for PrEP use in 18 nations by year‑end and is pursuing tiered pricing strategies for some middle‑income countries not covered by licenses.
• Officials aim to start up to 2 million people on the medicine by 2028, with availability in high‑burden regions potentially beginning later this year or early next following local approvals, and costs reported as low as about $100 per person per year.