Gov’t recommends registration of HIV prevention drug Lenacapavir

The Ministry of Health has recommended the registration of Lenacapavir, a long-acting HIV prevention medicine in a bid to strengthen Kenya’s fight against new infections.

In a statement dated January 9, 2026, the ministry, through the Pharmacy and Poisons Board, announced the recommendation for Lenacapavir 300 mg tablets and Lenacapavir 464 mg solution for injection, a long-acting antiretroviral medicine for HIV pre-exposure prophylaxis (PrEP).

According to the ministry, the decision follows scientific research and review of the drug’s suitability for use in the country.

“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,” stated Health Cabinet Secretary Aden Duale.

CS Duale said the drug works by blocking key stages in the HIV lifecycle, helping prevent infection.

Unlike daily PrEP pills, the injectable option is administered only twice a year, making it suitable for people who struggle with daily medication.

“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,” noted CS Duale.

Kenya now becomes one of the first African countries to recommend the medicine for registration, a move the government says aligns with global guidance on HIV prevention.

“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,” added Duale.

Despite the past roll out of daily oral PrEP nationwide, the government acknowledges that “some people experience difficulties with long-term daily pill use due to factors such as pill fatigue, stigma, or challenges with adherence.”

It says long-acting options like Lenacapavir will reduce how often medicine needs to be taken and broaden access to effective HIV prevention.

Duale said that Kenya has been prioritised for the initial rollout through global partnerships, with plans underway to ensure fair and responsible access for populations at substantial risk.

At the same time, the ministry reaffirmed reaffirmed its commitment to reducing new infections while ensuring all approved health products meet strict standards, saying it remains focused on advancing the national goal of ending HIV as a public health threat.