Developed by the U.S.-based company Gilead Sciences, Lenacapavir underwent Phase III trials, with key interim results reported in June and September 2024. The results demonstrated that the drug was 99.9% effective in preventing HIV infection. It received FDA approval for HIV prevention in June 2025.
Dr. Meg Doherty, Director of Global HIV, Hepatitis, and STI Programs at the World Health Organisation (WHO) in Geneva, highlighted the significance of this new prevention method at the ongoing conference in Kigali.
'Lenacapavir PrEP is a really important innovation that can be taken every six months to prevent new HIV infections,' said Dr. Doherty. 'We are pleased to bring new WHO guidelines on this long-acting injectable prevention option to the IAS meeting here in Kigali.'
The new WHO guidelines also recommend the use of rapid diagnostic tests to simplify and improve access to PrEP before, during, and after treatment. This helps in efficiently monitoring infections.
The Global Fund and the Children's Investment Fund Foundation (CIFF) have committed to supplying lenacapavir to at least nine early adopter countries starting in early 2026, with Rwanda currently engaged in discussions on how to access and roll out the drug.
'The medicine will be provided free of charge initially, but countries will need to invest in healthcare workers and delivery systems to support its distribution,' Dr. Doherty explained. 'Over time, prices are expected to be comparable to or slightly above current oral PrEP costs.'
The initial global target is to reach two million users per year, with plans to expand coverage based on demand and forecasting.
The injectable is expected to be especially impactful among populations with high HIV transmission rates, including men who have sex with men, sex workers, transgender people, prisoners, as well as adolescent girls, young women, and pregnant women.
'This intervention could be a game-changer in reducing HIV infections in key populations and vulnerable groups,' Dr. Doherty said.
Rwanda has made remarkable strides in the fight against HIV/AIDS. According to the Ministry of Health (MINISANTE), the latest data shows only 7 out of every 100 daily deaths in Rwanda are HIV-related, down from 20 a decade ago.
Rwanda has surpassed the United Nations 95-95-95 targets by reaching 96% of people living with HIV knowing their status, 98% of those on treatment, and 98% achieving viral suppression, which effectively prevents onward transmission.
Minister of Health Dr. Sabin Nsanzimana told IGIHE that Rwanda is already transitioning from daily multi-pill regimens to simpler treatments, including monthly pills and now long-acting injectables like lenacapavir.
'We are moving from multiple daily pills to once-a-day dosing and soon to monthly or bi-annual injections. This shift aligns with our national HIV strategy and promises to improve adherence and health outcomes,' Dr. Nsanzimana said.
The IAS Conference on HIV Science is the world's premier forum for sharing cutting-edge HIV research and innovations.
The 2025 edition, themed 'Breakthroughs amid Crisis: the Future of HIV Innovation,' gathers about 4,000 global experts focused on accelerating equitable access to new prevention and treatment options despite funding challenges.
Wycliffe Nyamasege
