The Ministry of Health has moved to strengthen Kenya’s fight against new HIV infections by recommending the registration of Lenacapavir, a long-acting HIV prevention medicine that experts say could transform how people protect themselves from the virus.
In a statement dated January 9, 2026, the ministry, through the Pharmacy and Poisons Board, confirmed that it had recommended Lenacapavir 300 mg tablets and Lenacapavir 464 mg injectable solution for use as HIV pre-exposure prophylaxis (PrEP). The drug belongs to a new class of long-acting antiretroviral medicines designed to prevent HIV before exposure.
The ministry said scientists and regulators reached the decision after completing a detailed review of the medicine’s safety, quality, and effectiveness for use in Kenya.
“The recommendation follows a comprehensive scientific assessment of the quality, safety, and efficacy of Lenacapavir, conducted in line with Kenyan law and applicable international regulatory standards,” Health Cabinet Secretary Aden Duale said.
Duale explained that Lenacapavir works by blocking critical stages of the HIV life cycle, preventing the virus from establishing itself in the body. He said the medicine offers a major advantage over existing HIV prevention options because it does not require daily dosing.
“Its long-acting formulation allows it to be administered only twice a year, offering an important alternative to daily oral HIV prevention medicines… particularly beneficial for individuals who face challenges with taking pills every day,” Duale said.
Health officials noted that many people struggle to stay on daily oral PrEP because of pill fatigue, stigma, or difficulties maintaining strict routines. By contrast, the injectable Lenacapavir only requires two doses a year, making it easier for more people to stay protected consistently.
The government said Kenya now joins a small group of African countries that have taken the step to recommend the medicine for registration, a move that aligns the country with the latest global HIV prevention strategies.
“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 Organization, and reflects the country’s growing regulatory capacity and leadership in enabling timely access to innovative health technologies of public health importance,” Duale added.
The ministry revealed that global health partners have already prioritised Kenya for the initial rollout of Lenacapavir. Officials said they are working on plans to ensure the drug reaches populations at the highest risk of HIV infection in a fair, safe, and responsible way.
At the same time, the Ministry of Health reiterated that it will only approve products that meet strict regulatory standards, even as it pushes to expand access to new prevention tools. The government said it remains committed to reducing new HIV infections and advancing Kenya’s long-term goal of ending HIV as a public health threat.
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