The price is the main change. Gilead Sciences sells the brand-name version, Yeztugo, which is approved in the United States, the European Union and Canada, and lists it at $28,218 a year in the U.S. The generic cannot be sold in the U.S. because the brand-name drug is under patent there. The deal that produced it was worked out by Unitaid, the Clinton Health Access Initiative and Wits RHI, a research institute in South Africa, and a pricing agreement among them and Dr. Reddy's was announced in September 2025.

Gilead has also signed royalty-free licensing agreements with six generic manufacturers, covering specific regions of sub-Saharan Africa, Asia and Latin America. Even so, supply of the brand-name drug has fallen short of demand. Rollout began in South Africa earlier this year, where about eight million people live with HIV, and in August South African officials said only a generic would allow distribution at scale. More than 125,000 people in 10 early-adopter African countries have started on Gilead's version.

Users must test negative for HIV before each dose, a step meant to prevent drug-resistant strains from emerging. Common side effects are injection site reactions, headache and nausea. Two major clinical trials found the injections virtually eliminated new infections.

The generic is expected to reach some places within weeks, though countries that require their own national approvals may wait longer. U.S.-funded antiretrovirals need FDA approval even when they are not sold in the U.S., and the decision gives the World Health Organization and national regulators a basis to fast-track their own reviews. Zambia expects to receive supplies before the end of 2026, with World AIDS Day on December 1 as the hoped-for date. Access is expected to cover about 120 countries by year's end.

Carmen Pérez Casas of Unitaid said that "it has never been so fast that the generic product comes so soon after the originator is approved," adding that "with lenacapavir, we are much more hopeful." Dr. Philippe Duneton, Unitaid's executive director, said the partnership cut the time from scientific breakthrough to access to just over a year. Dr. Neil Buddy Shah, chief executive of the Clinton Health Access Initiative, said two near-100% effective injections a year address the difficulty of taking a pill every day. Carolyn Amole of the same organization said that reaching the roughly 20 million people who need preventive treatment could help end the epidemic.

Professor Saiqa Mullick, director of Wits RHI, and other partners said affordability alone will not be enough. They said wider access also depends on prepared health systems, trained providers and community involvement. The World Health Organization counted 41 million people living with HIV worldwide last year, and 570,000 deaths from HIV-related causes. The U.S. government and the Global Fund aim to put three million people on preventive treatment by 2028.