Gilead Sciences has finalized an agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir, its twice-yearly, long-acting HIV prevention medicine, to as many as two million people over the next three years. The arrangement targets low- and lower-middle-income countries, with Gilead providing the drug at no profit once it secures national regulatory approvals. Under the deal, the Global Fund will finance and coordinate procurement and distribution, while Gilead will maintain production until planned royalty-free generic manufacturing ramps up. The pact does not currently involve the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), leaving questions about additional funding sources for a broad rollout. Lenacapavir, cleared by U.S. regulators last month under the brand name Yeztugo, is administered every six months and has been hailed by researchers as the most potent pre-exposure prophylaxis yet developed. Access advocates have pressed Gilead for equitable global distribution; the company’s new accord is intended to bridge supply until generics become available, but middle-income countries excluded from licensing agreements may still face access gaps.
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