ZIMBABWE has taken a giant step in the fight against HIV with the anticipated rollout of Lenacapavir, a revolutionary long-acting injectable pre-exposure prophylaxis, scheduled for next year.
Training for healthcare workers to administer the new injections is underway.
This preparatory phase is crucial for ensuring a smooth and effective introduction of the novel prevention tool into the national HIV programme.
Lenacapavir represents a major advancement in HIV prevention, unlike daily oral PrEP pills, which require consistent adherence. This new drug is administered as a subcutaneous injection just twice a year.
This long-acting format is expected to overcome the challenge of pill fatigue and improve protection for individuals who find a daily regimen difficult to maintain.
The introduction of Lenacapavir is set to diversify HIV prevention options in Zimbabwe, offering a more discreet and convenient alternative.
This is particularly significant for reaching key populations and vulnerable groups who face barriers to accessing or using daily oral PrEP.
The rollout is part of Zimbabwe's broader, multi-faceted strategy to reduce new HIV infections. By incorporating next-generation tools like long-acting injectables alongside existing methods, the country aims to accelerate progress towards its public health goals and build on the successes of its current HIV prevention and treatment programmes.
Already the country is providing cabotegravir (CAB LA) -- a three monthly PrEP and the coming in of Lenacapavir is set to be transformative.
On Saturday, the Medicines Control Authority of Zimbabwe (MCAZ) announced that the ground-breaking drug -- which is administered only twice a year -- was cleared after an expedited 23-day review, highlighting its importance to public health.
MCAZ said Lenacapavir, submitted by Gilead on October 29, was assessed under its fast-track process because of its potential to reduce new HIV infections by offering an alternative to daily oral PrEP, which some users struggle to adhere to.
Lenacapavir is approved for adults and adolescents weighing at least 35kg, who are HIV-negative and at substantial risk of infection.
It is given as a six-monthly subcutaneous injection after an initial phase consisting of one injection and oral tablets taken on days one and two.
The authority said the medicine must be used alongside safer sex practices, including condom use and behavioural risk-reduction measures.
MCAZ director-general Mr Richard Rukwata said the rapid approval demonstrated the authority's commitment to expanding access to life-saving tools in the fight against HIV.
"The rapid approval of Lenacapavir reflects MCAZ's dedication to accelerating access to trusted, high-quality health products," he said.
"This milestone brings new hope for HIV prevention and reinforces our commitment to safeguarding public health."
The approval represents a major advancement in Zimbabwe's HIV prevention strategy, particularly for populations that face challenges with strict daily medication schedules.
MCAZ said its evaluation included a full assessment of the product's safety, efficacy and quality, using a regulatory reliance model that incorporated scientific reviews from the World Health Organisation Prequalification Programme to ensure a thorough and efficient process.