The U.S. government, through the President’s Emergency Plan for AIDS Relief (PEPFAR), has announced a groundbreaking commitment to expand access to lenacapavir for pre-exposure prophylaxis (PrEP). This long-acting twice-yearly injectable for HIV prevention will be introduced across 8–12 high-burden African countries starting in 2026 (1). This marks a major step forward in the global fight against HIV.
Why Lenacapavir Matters
Lenacapavir represents a breakthrough in HIV prevention. Unlike daily oral PrEP, its twice-yearly dosing can help overcome adherence challenges, making it a game-changer for communities most affected by HIV. Clinical trials have demonstrated that lenacapavir is more than 99% effective in preventing HIV infection (2). The drug is particularly promising for populations at elevated risk, including adolescent girls, pregnant and breastfeeding mothers and other vulnerable communities.
Access & Affordability
Affordability is central to this initiative. Gilead has committed to providing the drug at low-cost access. To support the initiative, Gilead is pursuing a two-part strategy: offering the drug at no profit until generics can meet demand and establishing voluntary licenses with generic manufacturers (3). With support from the Global Fund, the US government aims to reach 2 million people with this long-acting PrEP, addressing gaps in existing prevention programs (4). This initiative signals a new era in HIV prevention—one where innovation meets equity.
Lenacapavir in Africa
Africa is at the center of this landmark rollout, with countries such as Eswatini, Lesotho, Mozambique, Nigeria, South Africa, Uganda, Zambia, Zimbabwe and Kenya among the first countries set to introduce lenacapavir (5). This positions the continent at the forefront of HIV prevention innovation, where long-acting PrEP can help overcome persistent challenges with daily pill adherence. Scaling up a twice-yearly injectable will require investment in health system readiness, including training health workers, strengthening supply chains, and ensuring effective monitoring for safety and access (6).
Equally critical will be strong community engagement to build trust, address stigma, and reach those most affected by HIV—especially adolescent girls and young women in sub-Saharan Africa (7). Integrating lenacapavir into maternal health services, youth-friendly clinics, and existing HIV programs could expand access while advancing progress toward the UNAIDS 95-95-95 targets—ensuring that 95% of people living with HIV know their status, 95% of those diagnosed are on treatment, and 95% of those on treatment achieve viral suppression—and the 2030 goal of ending AIDS as a public health threat (8,9). If successful, Africa’s leadership in rolling out lenacapavir could serve as a global model for equitable access to innovative HIV prevention tools.
Conclusion
The introduction of lenacapavir marks more than just a new option for HIV prevention—it represents a shift toward equity, innovation, and resilience in Africa’s HIV response. By pairing scientific breakthroughs with community-centered delivery, African countries can help lead the way toward an AIDS-free future. With sustained investment, collaboration, and commitment, long-acting PrEP has the potential to transform prevention efforts and bring the world closer to achieving the goal of ending AIDS by 2030.
References
- PEPFAR Commits to Distributing Breakthrough HIV Drug Lenacapavir Demonstrating American Excellence in Science and American Leadership in HIV Prevention [Internet]. United States Department of State. [cited 2025 Sept 25]. Available from: https://www.state.gov/releases/the-united-states-presidents-emergency-plan-for-aids-relief/2025/09/pepfar-commits-to-distributing-breakthrough-hiv-drug-lenacapavir-demonstrating-american-excellence-in-science-and-american-leadership-in-hiv-prevention/
- Cantos VD, Ramírez BC, Kelley CF, Rio C del, Grinsztejn B. Lenacapavir: a potential game changer for HIV prevention in the Americas, if the game is played equitably. Lancet Reg Health – Am [Internet]. 2025 June 10 [cited 2025 Sept 25];47:101146. Available from: https://pmc.ncbi.nlm.nih.gov/articles/PMC12178911/
- Gilead Signs Royalty-Free Voluntary Licensing Agreements with Six Generic Manufacturers to Increase Access to Lenacapavir for HIV Prevention in High-Incidence, Resource-Limited Countries [Internet]. [cited 2025 Oct 2]. Available from: https://www.gilead.com/news/news-details/2024/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries
- Global Fund Secures Access to Breakthrough HIV Prevention Drug Lenacapavir for Low- and Middle-Income Countries [Internet]. [cited 2025 Sept 25]. Available from: https://www.theglobalfund.org/en/news/2025/2025-07-09-global-fund-secures-access-breakthrough-hiv-prevention-drug-lenacapavir/?utm_source=chatgpt.com
- Afri. Kenya among first African countries to roll out HIV prevention injection [Internet]. AfrinewsKE. 2025 [cited 2025 Oct 2]. Available from: https://afrinewske.com/kenya-among-first-african-countries-to-roll-out-hiv-prevention-injection/
- Gears of Lenacapavir for PrEP Rollout [Internet]. AVAC. [cited 2025 Sept 30]. Available from: https://avac.org/resource/report/gears-of-lenacapavir/
- Murewanhema G, Musuka G, Moyo P, Moyo E, Dzinamarira T. HIV and adolescent girls and young women in sub‐Saharan Africa: A call for expedited action to reduce new infections. IJID Reg [Internet]. 2022 Dec 1 [cited 2025 Sept 30];5:30–2. Available from: https://www.sciencedirect.com/science/article/pii/S2772707622001035
- Pretorius R. Advancing the 95-95-95 Targets: A Roadmap to End AIDS by 2030 [Internet]. Syenza News. 2024 [cited 2025 Sept 30]. Available from: https://news.syenza.com/advancing-95-95-95-hiv-targets-roadmap-end-aids-2030/
- Understanding measures of progress towards the 95–95–95 HIV testing, treatment and viral suppression targets | UNAIDS [Internet]. [cited 2025 Sept 30]. Available from: https://www.unaids.org/en/resources/documents/2024/progress-towards-95-95-95