Kenya has taken a major step towards expanding HIV prevention options after the Ministry of Health formally recommended the registration of Lenacapavir, a long-acting antiretroviral medicine for HIV pre-exposure prophylaxis (PrEP).
In a press release dated January 9, 2026, the Pharmacy and Poisons Board announced that it had approved Lenacapavir 300 mg tablets and Lenacapavir 464 mg solution for injection for pre-exposure prophylaxis (PrEP).
HIV Prevention Drugs for Kenyans
The decision follows a rigorous scientific assessment of the drug’s quality, safety, and efficacy, conducted in accordance with Kenyan law and international regulatory standards.
“This recommendation reflects our commitment to introducing health products that meet the highest standards of safety, quality, and effectiveness,” said Health Cabinet Secretary Aden Duale.
Kenya becomes one of the first African nations to endorse Lenacapavir, aligning with global public health guidance, including recommendations from the World Health Organization.
Lenacapavir is designed for use as PrEP, offering protection to HIV-negative individuals at substantial risk of infection.
Unlike daily oral PrEP, Lenacapavir’s long-acting formulation allows for administration just twice a year, a feature health experts say could significantly improve adherence and uptake.
“This is particularly beneficial for those who struggle with pill fatigue or adherence issues,” the Ministry noted.
The Ministry noted that Kenya’s move aligns with recent global public health guidance, including recommendations from the World Health Organization.
Huge Boost for Kenya
CS Duale said that the decision reflects Kenya’s leadership in enabling timely access to innovative medicines of public health importance, particularly in the fight against HIV, which remains a significant health challenge despite notable progress over the past decade.
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Explaining how the drug works, the Ministry stated that Lenacapavir interferes with critical stages of the human immunodeficiency virus lifecycle, thereby preventing infection before it can take hold.
“Lenacapavir works by interfering with critical stages of the human immunodeficiency virus (HIV) lifecycle, thereby preventing HIV infection. Its long-acting formulation allows it to be administered only twice a year, offering an important alternative to daily oral HIV prevention medicines.”
Preparatory planning for Lenacapavir’s rollout is underway through global partnerships, ensuring timely, equitable, and responsible distribution to populations at substantial risk of HIV infection.
In the statement, the PPB confirmed that Kenya has been prioritized for the initial rollout, thanks to international confidence in the country’s readiness to implement advanced HIV prevention strategies.
The Ministry further reaffirmed its commitment to reducing new HIV infections and expanding prevention options.
“We are determined to advance the fight against HIV while safeguarding the health of our citizens through products that meet the highest standards,” Duale stated.
Once fully approved and rolled out, Lenacapavir could complement existing prevention tools, including condoms, daily oral PrEP, and other biomedical interventions.
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The recommendation now paves the way for the final regulatory steps and programmatic planning that will determine how and when Lenacapavir becomes available within the public health system.
Current HIV Situation in Kenya
Kenya remains one of the countries most affected by HIV in sub-Saharan Africa, with an estimated 1.4 million people living with the virus.
The adult prevalence rate stands at 4.0%, and approximately 22,000 new infections were recorded in 2023.
AIDS-related deaths remain significant, with about 18,000 fatalities last year. Children account for nearly 86,000 cases, highlighting the need for sustained prevention efforts.
While 85% of people living with HIV are on antiretroviral therapy, challenges persist among key populations, including sex workers and men who have sex with men, where prevalence rates are excessively high.
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