By Staff Reporter
Harare — Zimbabwe has become one of the first African countries to green-light lenacapavir, a revolutionary long-acting HIV prevention drug.
The injectable medication was approved in a record 23 days, the Medicines Control Authority of Zimbabwe (MCAZ) announced last Friday.
The drug, administered only twice a year as a pre-exposure prophylaxis (PrEP) intervention, is being hailed as a game-changer in reducing new HIV infections and expanding prevention choices for vulnerable populations.
MCAZ noted that the application, submitted by U.S.–based Gilead Sciences on October 29, underwent an accelerated yet thorough assessment due to its substantial public-health impact.
MCAZ Director-General Richard T. Rukwata said the rapid approval marked a pivotal step forward in strengthening access to critical health interventions.
“The rapid approval of lenacapavir reflects MCAZ’s dedication to accelerating access to trusted, high-quality health products.
This milestone brings new hope for HIV prevention,” he said.
Lenacapavir is recommended for HIV-negative adults and adolescents weighing at least 35kg and is given as a subcutaneous injection every six months after a brief initiation phase.
It remains a complementary prevention method and must be used in conjunction with safer-sex practices such as condoms and risk-reduction behaviours.
MCAZ also relied on scientific evaluations from the World Health Organization’s Prequalification Programme to support its decision.
The timing of Zimbabwe’s approval coincides with the beginning of lenacapavir’s rollout across Africa.
Initial shipments, around 500 starter doses each, were delivered last week to Eswatini and Zambia, with more countries to follow.
Daniel O’Day, Gilead’s Chairman and CEO, described the programme as unprecedented in speed and reach.
“For the first time, a new HIV medicine is reaching communities in sub-Saharan Africa in the same year as its U.S. approval,” he said.
Regulatory submissions are currently underway in Rwanda, Tanzania, Botswana and additional high-burden nations.
The initiative aims to reach 18 countries that are representing roughly 70% of the region’s HIV burden by year-end 2025.
Global Fund Executive Director Peter Sands labelled lenacapavir “transformational,” noting that its impact will rely heavily on targeted implementation among the highest-risk groups.
To expand access, Gilead has partnered with six generic manufacturers under a royalty-free licensing agreement, enabling up to two million people from low-income, high-incidence regions to receive the drug at zero profit under Global Fund and PEPFAR backing.
A senior U.S. official, Jeremy Lewin, said the distribution aligns with the America First Global Health Strategy, which supports direct investment in global HIV reduction.
Zimbabwe is among the African nations already finalizing their national rollout strategy in coordination with PEPFAR and the Global Fund.
The twice-yearly dosing model is expected to significantly improve adherence, particularly among individuals who struggle with daily oral PrEP regimens.
National awareness campaigns and professional health-worker training programmes are now underway to ensure safe, effective delivery of the injection as it enters mainstream public-health use.
