Lenacapavir works by blocking critical stages of the HIV lifecycle, preventing infection. The assessment examined the drug’s quality, safety and efficacy in line with Kenyan laws and international regulatory standards.
NAIROBI, Kenya -Jan 10, 2025-Kenya’s decision to recommend the registration of lenacapavir, a long-acting HIV prevention drug endorsed by the World Health Organisation (WHO), marks more than a regulatory milestone. It signals a possible turning point in the country’s decades-long struggle to curb new HIV infections—one shaped as much by science as by human behavior, stigma, and access to care.
With this move, Kenya becomes one of the first African countries to greenlight the medicine, positioning itself at the forefront of a new generation of HIV prevention strategies that could redefine how protection is delivered, particularly to those who struggle with daily medication.
Why lenacapavir matters
Lenacapavir works by blocking critical stages of the HIV lifecycle, preventing the virus from establishing infection in the body. Unlike daily oral pre-exposure prophylaxis (PrEP), the injectable formulation is administered just twice a year, offering long-term protection with minimal dosing.
For many Kenyans at high risk of HIV—young women, men who have sex with men, sex workers, and mobile populations—this shift is potentially transformative.
“Taking a pill every day can be stressful, especially when others ask questions or judge you,” says Faith Njeri, a Mombasa-based PrEP user. “Knowing I can get an injection that lasts six months is a relief. It feels safer, private, and easier to stay protected.”
Daily PrEP has proven effective, but adherence remains a challenge. Pill fatigue, fear of disclosure, stigma, and unstable living conditions have all limited consistent use. A twice-yearly injection removes many of those barriers, offering convenience, privacy, and sustained protection.
The Pharmacy and Poisons Board approved lenacapavir 300mg tablets and 464mg injectable solution for registration following a comprehensive scientific review. According to the Health Ministry, the assessment examined the drug’s quality, safety, and efficacy, in line with Kenyan laws and international regulatory standards-an indication of the country’s growing regulatory maturity.
Health Cabinet Secretary Aden Duale said the move aligns Kenya with global public health guidance while reinforcing its leadership in Africa.
“Kenya is among the first African countries to recommend Lenacapavir for registration, a decision that aligns with recent global public health guidance, including recommendations by the World Health Organisation, and reflects the country’s growing regulatory capacity and leadership in enabling timely access to innovative health technologies of public health importance,” Duale said.
Kenya’s HIV picture
Kenya has made notable progress in its HIV response over the past decade. According to UNAIDS and Ministry of Health data, more than 1.5 million Kenyans are living with HIV, while new infections have declined by about 40 percent during the same period.
Access to daily oral PrEP has expanded nationwide, now available in all 47 counties, with over 200,000 people currently on the regimen. Despite these gains, the epidemic persists, with thousands of new infections recorded annually.
HIV prevalence among adults is estimated at 4.9 percent, though it remains higher in key populations, highlighting ongoing gaps in prevention coverage and adherence rather than lack of medical tools.
“I’ve been on PrEP for two years, but sometimes I miss doses because I travel for work,” says James Ochieng, a PrEP user. “An injection every six months would make it so much easier to stay protected.”
Health experts argue that ending HIV as a public health threat will require choice, flexibility, and people-centred approaches, not one-size-fits-all solutions. Lenacapavir adds a powerful option to that prevention toolbox.
Global health partners have prioritised Kenya for the initial rollout of lenacapavir, with preparatory work already underway to ensure its introduction is timely, equitable, and responsible, particularly for populations at substantial risk.
If successful, Kenya’s experience could serve as a model for the rest of the continent, where adherence challenges and stigma remain major obstacles to HIV prevention.
However, experts caution that innovation alone is not enough. Questions around cost, supply sustainability, health worker training, community acceptance, and long-term financing will shape how impactful lenacapavir ultimately becomes.
Looking ahead
The Ministry of Health says all new health products will continue to undergo rigorous scrutiny before reaching the public. “The Ministry of Health reaffirms its commitment to expanding HIV prevention options, reducing new HIV infections, and advancing the national goal of ending HIV as a public health threat, while ensuring that all health products introduced in the country meet the highest standards of safety, quality, and effectiveness,” Duale said.
For now, lenacapavir represents something rare in the HIV response: fresh momentum. Not a cure. Not a vaccine. But a reminder that science, policy, and community trust, when aligned, can bend the curve of an epidemic that has shaped generations of Kenyan lives.
