Gilead Sciences announced an expanded investment from the U.S. State Department, PEPFAR, and The Global Fund to increase global access to its long-acting HIV prevention therapy, lenacapavir. The additional commitment is expected to extend access to up to 1 million more people over the next three years, bringing total planned reach to approximately 3 million individuals in high-incidence, resource-limited countries through 2028.
Lenacapavir, a twice-yearly injectable pre-exposure prophylaxis treatment, represents a significant advancement in HIV prevention, particularly in regions with high transmission rates such as sub-Saharan Africa. The therapy has already begun reaching communities shortly after its approval, with initial shipments delivered in late 2025.
The expanded partnership leverages the global distribution infrastructure and in-country expertise of PEPFAR and The Global Fund to accelerate delivery to populations most in need. As part of its broader access strategy, Gilead is providing lenacapavir at no profit to these organizations in priority markets while working toward long-term affordability through generic manufacturing.
Gilead has also entered voluntary licensing agreements with six generic manufacturers and expects large-scale generic rollout to begin in 2027. The company is coordinating with governments and program implementers to prepare for broader availability as part of its efforts to reduce new HIV infections globally, which currently total approximately 1.3 million annually.
The initiative underscores a coordinated global effort to expand access to innovative prevention tools and address persistent gaps in HIV prevention, particularly in underserved regions.
KEY QUOTE:
“Lenacapavir represents one of the most important breakthroughs ever seen in HIV prevention, and Gilead’s priority is to ensure broad access as quickly as possible. We expect large-scale generic rollout starting in 2027 and, in the meantime, Gilead is providing lenacapavir at no profit to the Global Fund and PEPFAR in countries with the most urgent need today. This additional commitment further expands access to lenacapavir as we build toward broad, affordable access and global impact.”
Daniel O’Day, Chairman And Chief Executive Officer, Gilead Sciences
