Full Breakdown
Lenacapavir Injection Approved as New HIV Prevention Tool, but Access Remains Unequal
By Drooid · · How we work
Core Event
The U.S. Food and Drug Administration approved the long-acting injectable lenacapavir for HIV pre-exposure prophylaxis (PrEP) in June 2025. In a 2024 clinical trial of more than 2,000 young women in South Africa and Uganda, none of the participants who received the drug contracted HIV, prompting the World Health Organization to add it to its recommended PrEP options.
Access Challenges
In the United States the drug costs roughly $28,000 per person annually, while generic versions are projected to cost about $40 per year. Gilead Sciences, the developer, supplies its own version at no profit to programmes funded by the Global Fund and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) in countries such as South Africa, Kenya, Zambia, Nigeria and Eswatini. However, the licensed generic rollout is not expected until 2027, and at least 26 middle-income nations—including Brazil, Mexico, Argentina and Peru—are excluded from Gilead’s generics agreement. MSF notes that those excluded nations accounted for close to 23 percent of new HIV infections worldwide in 2023.
Official Statements & Responses
She added that MSF has repeatedly requested permission to purchase lenacapavir directly from Gilead without a discounted price, but Gilead has not granted such access. In an emailed statement, Gilead described its access strategy as a combination of no-profit supplies, royalty-free licensing and regional agreements, while declining to comment on the exclusion of specific countries.
Why It Matters
UNAIDS reports that international HIV funding fell 18 percent in 2025 to $7.3 billion, the lowest level in nearly two decades, causing a drop in the number of people receiving PrEP from 1.4 million in 2024 to 1.1 million in 2025. Projections indicate that close to 20 million people worldwide would need access to any form of PrEP to substantially curb new infections. The limited availability of lenacapavir, especially in humanitarian crises where daily pill adherence is difficult, could therefore shape the trajectory of the global HIV response.
Potential Legal Pathways
World Trade Organization rules, reaffirmed by the 2001 Doha Declaration, allow governments to issue compulsory licences or other safeguards to bypass patent restrictions for public-health emergencies. Brazil previously employed such measures for the HIV drug efavirenz in 2007 and activists are urging a similar approach for lenacapavir if patent barriers impede affordable generic access. MSF calls on governments to consider these mechanisms and on Gilead to ensure its licensing agreements do not block supply to countries that invoke them.