Gilead Sciences, Inc. has entered a strategic agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir, its long-acting injectable HIV-1 capsid inhibitor, for use as pre-exposure prophylaxis (PrEP). Under this partnership, Gilead will provide enough lenacapavir to reach up to two million people over three years in Global Fund-supported countries—at no profit.
This follows Gilead’s October 2024 move to sign voluntary, royalty-free licensing agreements with generic manufacturers to produce and supply lenacapavir across 120 high-incidence, resource-limited countries, primarily in the low- and lower-middle-income (LLMIC) group. Until affordable generic options become widely available, Gilead has committed to supplying its branded lenacapavir at no profit in these regions.
The Global Fund will prioritize early-access rollout based on local HIV epidemiology, national prevention plans, and available funding. Gilead is also engaging with other international health partners to further accelerate access.
“This partnership reflects our shared goal of reaching as many people as possible, as quickly as possible, with this breakthrough in HIV prevention,” said Daniel O’Day, Chairman and CEO of Gilead Sciences. “By supplying lenacapavir at no profit ahead of generic availability, we aim to contribute meaningfully to ending the HIV epidemic.”
Peter Sands, Executive Director of the Global Fund, added, “Long-acting PrEP like lenacapavir could transform HIV prevention—but only if it reaches those most at risk. Our goal is to deliver it to two million people, but this will require strong global support and funding.”
Gilead's licensing approach, initiated even before regulatory approvals, is the earliest and most expansive ever undertaken for an HIV prevention medicine. In February 2025, the European Medicines Agency validated Gilead’s EU-M4all application for lenacapavir for PrEP, a process that can help LLMICs fast-track their own regulatory reviews using the EMA’s opinion.
To meet demand until generics are available, Gilead has secured at-risk manufacturing capacity to produce injectable lenacapavir and oral initiation doses for up to two million people. Additional production can be scaled to meet broader demand in collaboration with countries and global procurement agencies.