Its registration marks a major step toward expanding the
country’s HIV prevention options.
In a statement on Friday, the ministry said the Pharmacy and
Poisons Board had approved Lenacapavir 300 mg tablets and Lenacapavir 464 mg
solution for injection for registration after a comprehensive scientific
review.
The assessment examined the drug’s quality, safety and
efficacy in line with Kenyan laws and international regulatory standards.
Kenya is now among the first African countries to recommend
Lenacapavir for registration, a move the ministry said aligns with recent World
Health Organization guidance.
"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," Health CS Aden Duale said.
He noted that the decision reflects the country’s growing
regulatory capacity and leadership in enabling timely access to innovative
public health technologies.
Lenacapavir works by blocking critical stages of the HIV
life cycle, preventing infection.
Its long-acting injectable formulation allows for administration
just twice a year, offering an alternative to daily oral pre-exposure
prophylaxis (PrEP).
This option is expected to benefit individuals who face
difficulty taking daily pills due to stigma, pill fatigue, or challenges with
adherence.
Kenya has expanded access to daily oral PrEP across all 47
counties in recent years.
However, the Ministry acknowledged that some people struggle
with consistent pill use.
Long-acting options such as Lenacapavir could help close
that gap by offering a more convenient prevention method.
Global health partners have prioritised Kenya for the
initial rollout of Lenacapavir, and preparatory work is already underway to
ensure its introduction is timely, equitable and responsible for populations at
substantial risk of HIV infection.
However, not everyone will be eligible for the injection
since guidelines prioritise adults and adolescents who weigh at least 35 kilogrammes.
They must also be HIV-negative before and
while receiving the injections.
Individuals considered to be at substantial
risk of HIV acquisition through sex will be prioritised.
The ministry said the registration underscores its
commitment to reducing new HIV infections, broadening prevention choices and
advancing national efforts to end HIV as a public health threat.
Duale added that all new health products will continue to
undergo rigorous assessment to ensure safety, quality 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," he said.
HIV is mainly transmitted through unprotected sex.
