Gilead Announces Partnership With PEPFAR

Gilead Sciences entered a partnership with the U.S. State Department and the United States President’s Emergency Plan for AIDS Relief (PEPFAR) to deliver lenacapavir—Gilead’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis (PrEP). 

This is a key component of Gilead’s larger coordinated efforts, now bringing together the resources and expertise of PEPFAR and the Global Fund, to further advance access to lenacapavir for PrEP for up to two million people over three years in countries supported by both organizations.

These agreements allow for the generic manufacturers to seek regulatory approvals for lenacapavir for PrEP and provide access in sufficient volumes to meet demand and generate competition to drive down costs. By the end of 2025, Gilead intends to complete regulatory submissions for lenacapavir for PrEP in 18 countries. 

The company will provide Gilead-supplied product at no profit until generic manufacturers can fully support demand in those countries, including through its strategic partnership agreements with PEPFAR and the Global Fund to supply lenacapavir for PrEP for up to two million people.

This milestone marks Gilead’s latest progress in executing its ambitious access strategy to enable broad, sustainable access to lenacapavir for PrEP in primarily low- and lower-middle-income countries (LLMICs), if approved. 

Gilead has secured royalty-free agreements with six generic manufacturers to cover 120 high-incidence, resource-limited countries that account for a large share of the global HIV burden.

Gilead is working to secure approvals in key high-incidence, resource-limited countries as quickly as possible in relation to the recent U.S. approval, European Commission marketing authorization, and a positive EU-Medicines for all (EU-M4all) opinion.

“Accelerating access to innovations like lenacapavir is imperative if we are to turn the tide against HIV,” said Peter Sands, Executive Director of the Global Fund. “In a severely resource-constrained environment, we must ensure that breakthrough tools are deployed rapidly, affordably, and in the most impactful way possible. By targeting where lenacapavir can have the greatest effect, and working with the U.S. and Gilead, we can help countries integrate it efficiently into their HIV prevention programs—reducing new infections and enabling them to move more quickly along the pathway toward transition and self-reliance.”