WHO Endorses Lenacapavir for Global HIV Prevention
The World Health Organization (WHO) has updated its HIV prevention guidelines in 2025. It now recommends lenacapavir, a new long-acting antiretroviral, for people at high risk and areas with high HIV infection rates. This announcement was made at the 13th International AIDS Society Conference in Kigali, Rwanda. Lenacapavir was approved by the US FDA as a twice-yearly injectable pre-exposure prophylaxis (PrEP) treatment. This marks a key advancement in HIV prevention worldwide.
Lenacapavir – A Breakthrough in HIV Prevention
Lenacapavir is a long-acting injectable drug developed by Gilead Sciences in New Delhi. It belongs to the capsid inhibitor class. This drug blocks multiple steps in the HIV replication process. Initially approved for HIV treatment in 2022, lenacapavir gained approval for prevention in 2024. Unlike daily oral PrEP pills, lenacapavir requires only two injections per year. This feature improves adherence and benefits those with limited healthcare access or stigma concerns.
WHO’s Revised Prevention Strategy
WHO’s endorsement of lenacapavir reflects a broader strategy to expand HIV prevention tools. The organisation aims to offer people more choices beyond daily pills. The new guidelines promote use of lenacapavir especially for populations at high risk. These include sex workers, men who have sex with men, transgender individuals, injecting drug users, prisoners, children, and adolescents. WHO also supports simplified HIV testing with rapid diagnostic kits to facilitate access.
Challenges in Global HIV Prevention
Despite advances, global HIV prevention has stalled. In 2024, about 1.3 million new infections were reported. Funding cuts, especially from the US, threaten progress. The US reduced aid to programmes like USAID and PEPFAR. This has led to sharp declines in PrEP use in countries like Nigeria. The United Nations warns that millions could die from HIV-related causes by 2029 if funding is not restored. Some low- and middle-income countries plan to increase domestic spending but may not fully offset lost aid.
Access and Affordability of Lenacapavir
Gilead Sciences has partnered with the Global Fund to provide lenacapavir at cost price. This means no profit margin will be charged in low- and middle-income countries. In the US, the drug’s annual list price is about $28,218, similar to other PrEP treatments. The cost-effective supply model aims to improve accessibility in resource-limited settings. WHO and partners are working to ensure rapid and safe distribution of this new prevention option.
Future Directions in HIV Prevention
The introduction of lenacapavir signals a shift towards long-acting prevention methods. It offers a promising alternative to daily adherence challenges. Combined with rapid testing and community delivery models, it could transform HIV prevention. However, sustained funding and global cooperation remain critical to maximise impact.
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