The Ministry of Health (MoH) has approved preparations for the rollout of Lenacapavir, a long-acting HIV prevention drug. This approval marks a significant milestone in Kenya’s efforts. It aims to expand HIV prevention choices and reduce new infections.
The decision follows the Ministry’s recommendation last week for the registration of Lenacapavir. The Pharmacy and Poisons Board (PPB) approved the medicine for registration after a comprehensive scientific review. The approval clears the path for rollout planning. It positions Kenya among the first African countries to introduce the innovative HIV prevention technology.
Regulatory Approval Following Rigorous Scientific Review
In a statement issued on Friday, the Ministry confirmed that the PPB had approved Lenacapavir 300 mg tablets. They also approved Lenacapavir 464 mg solution for injection for registration. This followed an extensive assessment of the drug’s quality. The assessment also reviewed its safety and efficacy.
The review process followed Kenyan laws and international regulatory standards. This reflects the country’s growing capacity to evaluate and approve advanced health technologies.
Health Cabinet Secretary Aden Duale noted that the approval aligns with recent World Health Organization (WHO) guidance. It underscores Kenya’s leadership in enabling timely access to innovative public health interventions.
“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,”
-CS Aden Duale
From Registration to Rollout: What the Decision Means
The recommendation for registration marked a regulatory breakthrough. The Ministry is now working with partners to operationalise the rollout of Lenacapavir. This is part of the national HIV prevention programme.
Global health partners have prioritised Kenya for the initial rollout. Preparatory activities are already underway. These efforts ensure that the introduction of the drug is timely, equitable, and responsible. This is particularly important for populations at substantial risk of HIV infection.
The Ministry has indicated that rollout planning will be guided by national HIV prevention strategies, clinical guidelines, and equity considerations. This approach will ensure that those most in need are reached.
How Lenacapavir Works
Lenacapavir is a long-acting injectable HIV prevention medicine. It works by blocking critical stages of the HIV lifecycle. This action prevents infection.
Unlike daily oral pre-exposure prophylaxis (PrEP), Lenacapavir is administered once every six months. It offers a highly effective alternative for HIV prevention. Recent studies have shown that the drug is comparable in effectiveness to daily oral PrEP in preventing HIV infection. This is true even in cases of unprotected sex.
The long-acting formulation represents a major shift in HIV prevention by reducing the burden of daily pill-taking.
Addressing Gaps in Daily PrEP Adherence
Kenya has made significant progress in expanding access to daily oral PrEP across all 47 counties. This expansion makes it a cornerstone of the country’s HIV prevention strategy.
However, the Ministry acknowledges that not everyone is able to adhere consistently to daily medication. Barriers include stigma, pill fatigue, forgetfulness, and broader challenges related to long-term adherence.
Long-acting options such as Lenacapavir are expected to help close this gap. They offer a discreet and convenient alternative for individuals who struggle with daily pills.
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Who Will Be Eligible for the Injection?
Despite its promise, Lenacapavir will not be available to everyone immediately. According to the Ministry, eligibility guidelines will prioritise:
- Adults and adolescents weighing at least 35 kilogrammes
- Individuals who are HIV-negative before starting the injections and throughout the course of use
- People considered to be at substantial risk of HIV acquisition through sex
These criteria are intended to ensure safe and effective use of the drug while maximising public health impact.
Strengthening Kenya’s Leadership in HIV Prevention
The Ministry said the approval and planned rollout of Lenacapavir underscores Kenya’s commitment to broadening HIV prevention choices. It reduces new infections. Additionally, it advances national and global goals to end HIV as a public health threat.
CS Duale emphasised that all new health products introduced in the country will continue to undergo rigorous regulatory assessment.
“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,”
-CS Aden Duale
A Step Forward in Ending HIV
The approval of Lenacapavir for rollout comes at a critical moment. Kenya is intensifying efforts to curb new HIV infections. These efforts focus particularly on populations facing heightened risk.
The Ministry has demonstrated a strong policy commitment to innovation, and it is equally committed to equity and evidence-based prevention.
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