NextFin news, On Wednesday, September 24, 2025, major global health organizations and pharmaceutical companies revealed agreements to provide the HIV prevention drug lenacapavir at a drastically reduced price of $40 per patient per year in over 100 low- and middle-income countries starting in 2027.
Lenacapavir, a twice-yearly injectable pre-exposure prophylaxis (PrEP) drug developed by Gilead Sciences, has been hailed as a breakthrough in HIV prevention due to its high efficacy and ease of use compared to daily oral pills. Clinical trials demonstrated near-complete protection against HIV infection, especially among high-risk groups such as young women, men who have sex with men, transgender individuals, and sex workers.
The World Health Organization recommended lenacapavir for HIV prevention in July 2025, describing it as "the next best thing" to an HIV vaccine. However, the drug's initial launch in the United States came with a list price exceeding $28,000 per year, making it unaffordable for most resource-limited settings.
To address this, Gilead Sciences granted voluntary licenses to six generic manufacturers, including Dr Reddy's Laboratories and Hetero Labs, to produce affordable versions of lenacapavir for 120 countries with high HIV incidence. Partnerships involving the Global Fund, Unitaid, the Clinton Health Access Initiative, and the Gates Foundation will support procurement and distribution efforts.
The Global Fund announced it will purchase lenacapavir supplies on behalf of eligible countries, aiming to reach up to two million people by 2028. The $40 annual price point aligns lenacapavir with the cost of existing oral PrEP pills, improving accessibility for vulnerable populations who often face stigma and adherence challenges with daily medication.
South Africa plans to roll out lenacapavir at over 300 government clinics in high-incidence districts between April 2026 and March 2028, initially using branded products funded by the Global Fund. The country expects to begin purchasing generics by April 2027, potentially expanding access to thousands of primary healthcare facilities. The South African Health Products Regulatory Authority is conducting an expedited review, with registration anticipated by late 2025.
Despite these advances, challenges remain. The United States' President's Emergency Plan for AIDS Relief (PEPFAR) has reduced funding for HIV prevention projects, limiting its role in supporting lenacapavir rollout. Additionally, the exact pricing details between Gilead and the Global Fund remain confidential, raising concerns about transparency and affordability for middle-income countries.
Experts emphasize that widespread uptake of lenacapavir is critical to curbing the global HIV epidemic. Modeling studies suggest that if millions of people in high-burden countries use the drug consistently, it could help end AIDS as a public health threat by 2030-2032.
Global health leaders call for urgent additional investments and coordinated efforts to ensure equitable access to lenacapavir, highlighting the drug's potential to transform HIV prevention worldwide.
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