Gilead Joins Partners for Delivery of First Shipments of Breakthrough Twice-yearly Lenacapavir for HIV Prevention to Sub-Saharan Africa

Gilead Sciences announced the first shipments of lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor for pre-exposure prophylaxis (PrEP), to Eswatini and Zambia. This milestone aims to accelerate equitable access to long-acting HIV prevention in sub-Saharan Africa, which bears two-thirds of the global HIV burden.
The initiative involves partnerships with the Global Fund, PEPFAR, and local governments to ensure rapid deployment and training of health workers. Lenacapavir reached these countries just five months after U.S. FDA approval, marking unprecedented speed in global HIV prevention efforts.
By end of 2025, Gilead plans regulatory submissions in 18 countries representing 70% of the regional HIV burden. Approvals have already been granted in South Africa and Zambia, with filings underway in several others. Gilead also signed royalty-free agreements with six generic manufacturers to supply 120 resource-limited countries, aiming to provide lenacapavir at no profit for up to two million people until generics meet demand.
The company emphasizes collaboration with governments and organizations to strengthen health systems and ensure sustainable access. In middle-income countries not covered by licensing agreements, Gilead is pursuing tailored strategies for rapid access.
Currently, lenacapavir for HIV prevention is approved only in the U.S., EU, South Africa, and Zambia. In Eswatini, it was imported under special authorization based on prior stringent regulatory approval and WHO prequalification.

Additional information to the following link: Gilead Joins Partners for Delivery of First Shipments of Breakthrough Twice yearly Lenacapavir for HIV Prevention to Sub Saharan Africa