Kenya to Roll Out Long-Acting Injectable HIV Prep Lenacapavir By Jan 2026

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Nairobi — Kenya is set to roll out the long-acting injectable HIV Pre-Exposure prophylaxis (PrEP) Lenacapavir by January 2026 following its approval by the World Health Organization.

In a statement, Health Cabinet Secretary Aden Duale stated that the Ministry is developing rollout guidelines and eligibility.

He indicated that "this biomedical breakthrough marks a significant milestone in Kenya's fight against HIV, offering individuals at substantial risk a highly effective and discreet alternative to daily (PrEP)."

He stated that the Ministry of Health has already developed an implementation plan and through a consultative process with stakeholders, "we are finalizing national guidelines to facilitate a smooth scale-up."

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He stated that the Ministry is mobilizing the necessary systems and resources to guarantee the timely availability of the intervention.

He urged stakeholders to align their efforts, enhance delivery platforms and support the transformative journey.

Lenacapavir received approval from the US Food and Drug Administration (FDA) in June 2025 and has been subsequently endorsed in the updated World Health Organisation (WHO) guidelines on long-acting HIV prevention released in July 2025.

This milestone follows promising 2024 results from the PURPOSE 1 AND PURPOSE 2 trials, which demonstrated the safety and efficacy of lenacapavir across diverse populations and settings.

Administered just twice a year, lenacapavir offers sustained protection and adds to the growing range of HIV prevention options.

WHO currently recommends oral PrEP, the dapivirine vaginal ring, and long-acting injectable cabotegravir (CAB-LA) as options for HIV pre-exposure prophylaxis (PrEP).

Lenacapavir's discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits, and stigma associated with HIV prevention.

"This regulatory milestone brings us one step closer to expanding access to an innovative HIV prevention option in lenacapavir,"said Dr Meg Doherty, Director of WHO's Global HIV, Hepatitis and STI Programmes.

"WHO plays a key role in supporting countries through guideline development, prequalification, and regulatory processes. We are working with partners and national authorities to ensure lenacapavir reaches people who need it most - quickly, safely and equitably."

WHO guidelines for injectable lenacapavir were released on 14 July 2025, during the International AIDS Conference in Kigali.

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