Commentary: Edging closer to lenacapavir access in low- and middle-income countries

Generic lenacapavir, a long-acting pre-exposure prophylaxis (PrEP), is expected to reach people in low- and middle-income countries (LMICs) within three years of publication of Phase III trial results – well ahead of the six years or more typically required for similar medicines.¹ The twice-yearly injections will be priced at USD 40 per person per year, a cost comparable to currently available daily oral PrEP regimens and consistent with independent estimates.² The Access to Medicine Foundation welcomes both the transparency on pricing and the overall speed at which access is being ensured. 

These developments are driven by Gilead and the new partnerships between the Gates Foundation and Hetero Labs, as well as between Unitaid, the Clinton Health Access Initiative, Wits RHI, and Dr. Reddy’s Laboratories. The accelerated timeline is further facilitated by Gilead’s non-exclusive voluntary licensing agreement (NEVL) and technology transfer to six generic manufacturers, including Hetero Labs and Dr. Reddy’s Laboratories, which were agreed before its first regulatory approval of lenacapavir for prevention – an approach recognised by the Access to Medicine Foundation as best practice. Together, these efforts align with Gilead’s 2024 Index opportunity to ensure fast and equitable access to lenacapavir in LMICs, including through collaboration with generic sublicensees.  

However, some questions remain. First, what percentage of people in need of PrEP globally will be reached by lenacapavir, over what timeframe, and what impact will this have on ending the HIV epidemic. Second, how will Gilead ensure access in the 17 LMICs^* in scope of the 2024 Index but excluded from the licence, given that these countries accounted for 19% of new HIV cases in 2023, mostly in Central and South America.^**,3-7 

The Access to Medicine Foundation recognises Gilead’s efforts to address these access gaps through agreements with the Global Fund and PEPFAR (running until 2028), regulatory submissions, engagement with the Pan American Health Organization (PAHO), and its stated commitment to tiered pricing and public-private partnerships. However, these strategies do not all necessarily guarantee affordable and sustainable access for all who need it in these countries. The Access to Medicine Foundation expects more clarity on this in the near future.  

The Access to Medicine Foundation will continue to monitor how these commitments translate into real-world impact: 

• Dr. Reddy’s Laboratories and Hetero Labs can publicly report on their progress in meeting these new commitments. 

• The other four licensees – Emcure, Eva Pharma, Ferozsons Laboratories Limited and Mylan – can provide updates on the introduction of their version of generic lenacapavir. 

• Gilead can provide ongoing updates on how it is ensuring equitable and affordable access, both before generic versions reach LMICs in 2027 and in countries not covered by the voluntary licence. 

Planning for lenacapavir access in LMICs is moving at a notable pace, prompting a broader question: Should the same urgency and scale now be expected for other communicable diseases, such as tuberculosis and malaria, which also benefit from extensive networks of organisations and companies working to improve access? 

_{^*Out of the 120 countries covered by the NEVL, 96 are included in the 2024 Index. Of the 113 countries in the scope of the 2024 Index, 17 are excluded from Gilead’s NEVL : Algeria, Brazil, China, Colombia, Ecuador, El Salvador, Guatemala, Iran, Iraq, Jordan, Kosovo, Lebanon, Mexico, Paraguay, Peru, State of Palestine, Venezuela.}

_{^**State of Palestine is the only country without public data on the number of new HIV cases in 2023 and thus has not been considered in the analysis.}  

References:

1. _{AVAC. The Gears of Lenacapavir for PrEP Rollout.; 2024. Accessed September 26, 2025.  https://avac.org/lenacapavir/} 

2. _{Hill A, Levi J, Fairhead C, et al. Lenacapavir to prevent HIV infection: Current prices versus estimated costs of production. Journal of Antimicrobial Chemotherapy. 2024;79(11):2906-2915. doi:10.1093/jac/dkae305} 

3. _{HIV Rates by Country 2025. Accessed September 26, 2025. https://worldpopulationreview.com/country-rankings/hiv-rates-by-country} 

4. _{Luo S, Wang N. Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome Prevention and Control in China: Statistics, Challenges, and the Road Ahead. Infectious Diseases and Immunity. 2024;4(4):149-151. doi:10.1097/ID9.0000000000000126} 

5. _{Iraq: Majority of Kurdistan’s new HIV cases are foreigners, now facing deportation | HIV Justice Network. Accessed September 26, 2025. https://www.hivjustice.net/news-from-other-sources/iraq-majority-of-kurdistans-new-hiv-cases-are-foreigners-now-facing-deportation/} 

6. _{Kosovo / Rise in HIV Infections: 10 New Cases in Five Months - Euronews Albania. Accessed September 26, 2025. https://euronews.al/en/kosovo-rise-in-hiv-infections-10-new-cases-in-five-months/} 

7. _{Global Statistics | HIV.gov. Accessed September 26, 2025. https://www.hiv.gov/hiv-basics/overview/data-and-trends/global-statistics}