Govt Backs Approval of Injectable HIV Treatment in Kenya

The Ministry of Health, through the Pharmacy and Poisons Board, has recommended the registration of Lenacapavir, a long-acting antiretroviral medicine for HIV pre-exposure prophylaxis (PrEP).

In a statement dated Saturday, 10, 2026, Health CS Aden Duale stated that the approval covers Lenacapavir 300 mg tablets and Lenacapavir 464 mg injectable solution.

“The Ministry of Health, through the Pharmacy and Poisons Board, has recommended the registration of Lenacapavir 300 mg tablets and Lenacapavir 464 mg solution for injection, a long-acting antiretroviral medicine for HIV pre-exposure prophylaxis (PrEP),” read the statement.

CS Duale Recommends Adoption of Injectable HIV Drug

He stated that the recommendation follows a thorough scientific assessment of the drug’s quality, safety, and efficacy, conducted in line with Kenyan law and international regulatory standards.

Additionally, the Health CS stated that Kenya is among the first African countries to recommend Lenacapavir, aligning with World Health Organization guidance and reflecting the country’s growing capacity to provide timely access to innovative health technologies.

Lenacapavir works by blocking critical stages of the HIV lifecycle, preventing infection. Its long-acting formulation allows administration twice a year, offering a convenient alternative to daily oral HIV prevention pills, particularly for individuals who struggle with adherence due to pill fatigue or stigma.

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The CS noted that Kenya has expanded access to daily oral PrEP across all 47 counties. However, the injectable option is expected to broaden access to effective HIV prevention and reduce the challenges associated with daily pill use.

He stated that preparatory planning for the rollout is already underway, with the country prioritised for initial distribution through global partnerships.

At the same time, he reaffirmed the Ministry’s commitment to expanding HIV prevention options, reducing new infections, and advancing the goal of ending HIV as a public health threat, ensuring all medicines meet the highest standards of safety and effectiveness.

“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,” said the Health CS.

About the Drug

Lenacapavir is a long-acting antiretroviral medicine used for HIV pre-exposure prophylaxis (PrEP) and treatment of multidrug-resistant HIV.

Developed by Gilead Sciences, it belongs to a first-in-class group called capsid inhibitors, working by disrupting multiple stages of the HIV lifecycle, from cell entry to viral assembly and release, effectively preventing replication, even in drug-resistant strains.

For prevention, it is available as a 464 mg injection administered twice a year or 300 mg oral tablets, offering a convenient alternative to daily PrEP and helping people who struggle with adherence.

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For treatment, it is combined with other antiretrovirals in adults where standard therapies fail.

It was approved for treatment in the US, EU, and Canada in 2022, and for prevention by the Food and Drug Administration (FDA) in June 2025.

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