Fact Sheet
September 4, 2025
The U.S. government is making a pre-market commitment to purchase the drug lenacapavir from Gilead Sciences, an American Company. Lenacapavir is a new, extremely effective HIV prevention injection that only has to be taken twice a year. The President’s Emergency Plan for AIDS Relief (PEPFAR) will distribute lenacapavir in 8-12 high-burden HIV countries in 2026. With lenacapavir, PEPFAR is seeking to meaningfully reduce the number of new HIV infections, especially in pregnant and breastfeeding mothers.
Lenacapavir has been proven to be:
- Effective: In a large-scale clinical trial more than 99% of people on lenacapavir remained HIV negative.
- Convenient: Individuals prefer long-acting injectables such as lenacapavir as they only require twice-yearly visits.
- Cost-Efficient to Deliver: Individuals only have to visit the clinic twice per year, reducing the cost to initiate and deliver treatment.
The U.S. government and the Global Fund are co-funding this advanced market commitment to purchase lenacapavir for up to 2 million individuals by 2028. Gilead has agreed to provide the drug at cost. In addition, Gilead has agreed to provide their intellectual property to generic manufacturers who can produce the drug at scale and help bring down the price so that future purchases can be sustained by local governments.
PEPFAR is prioritizing the recipient countries based on countries’ HIV burden and the strength of the country’s existing infrastructure to distribute and deliver the drug. PEPFAR will be working with countries over the next several months to develop a rollout plan for lenacapavir, with a focus on prioritizing distribution to pregnant and breastfeeding mothers.