Lenacapavir, a twice-yearly injectable developed by Gilead Sciences, achieved something extraordinary in a 2024 clinical trial: zero HIV infections among more than 2,000 young women in South Africa and Uganda who received the drug. The World Health Organization has recommended it as an additional form of pre-exposure prophylaxis. The science is settled. The access architecture is not. The drug costs approximately $28,000 per person annually in the United States. Generic versions are expected to cost about $40 a year. Gilead has licensed six manufacturers to produce generics, but large-scale rollout is not expected until 2027. In the interim, Gilead is supplying its branded version at no profit for programmes supported by the Global Fund and PEPFAR, with rollouts in South Africa, Kenya, Zambia, Nigeria and Eswatini. The company plans to provide enough for up to three million people through 2028. Twenty-six middle-income countries are excluded from Gilead's generics agreement, according to Doctors Without Borders. Among them are Brazil, Mexico, Argentina and Peru — countries with rising HIV infections, and some that helped generate the clinical evidence proving lenacapavir works. Those excluded countries accounted for close to 23 percent of new HIV infections globally in 2023. Gilead has since announced a separate agreement with the Pan American Health Organization covering 14 Latin American and Caribbean countries, but MSF argues this leaves those nations dependent on Gilead rather than able to purchase cheaper generics independently. The timing compounds the problem. International funding for HIV fell 18 percent in 2025, to $7.3 billion — its lowest level in nearly two decades, according to UNAIDS. The number of people receiving any form of PrEP dropped from 1.4 million in 2024 to 1.1 million in 2025. MSF estimates close to 20 million people worldwide need PrEP access to substantially reduce new infections. Three million doses through 2028 is a fraction of that need. MSF itself has been unable to purchase the drug. For more than a year, the organisation says it has sought permission to buy lenacapavir directly from Gilead for its medical programmes — without demanding a discounted price — and been refused. This matters acutely in conflict and humanitarian settings where daily PrEP pills are impractical and sexual violence elevates HIV risk. Gilead declined Al Jazeera's request for an interview and did not reply to questions about why it will not sell to MSF or why certain countries were excluded. WTO rules offer a legal escape hatch. The 2001 Doha Declaration affirmed governments' right to issue compulsory licences, authorise government use of patents, or challenge patents they consider unjustified — all to protect public health. Brazil used these powers in 2007 to access cheaper generics of the HIV drug efavirenz after negotiations with Merck failed. Activists are now urging Brazil to consider the same approach for lenacapavir. MSF is also calling on Gilead to ensure its agreements with generic manufacturers do not prevent them from supplying countries that invoke such legal safeguards. The structural pattern here is familiar: a genuine scientific breakthrough captured inside a licensing architecture designed to maximise control, not reach. Gilead's strategy — no-profit branded supply to some, royalty-free licensing to six manufacturers, separate regional agreements for others — creates a patchwork that looks comprehensive on paper but leaves the company as gatekeeper for every access pathway. Whether governments wield their WTO rights or accept the current terms will determine whether lenacapavir reaches people based on epidemiological need or national income classification.
