By Dickson Bandera
Zimbabwe is poised to introduce Lenacapavir, a revolutionary HIV prevention drug, following its swift approval by the Medicines Control Authority of Zimbabwe (MCAZ).
Lenacapavir—widely regarded as one of the most promising advancements in HIV prevention—is a long-acting injectable developed by Gilead Sciences. It is administered just twice a year, offering a convenient and effective alternative to daily oral medications.
Clinical trials conducted across the United States, Europe, and Africa have shown up to 100% efficacy among high-risk populations.
Zimbabwe becomes one of the first 10 African nations set to benefit from the long-acting injectable, which experts say could significantly accelerate efforts to reduce new HIV infections.
MCAZ fast-tracked the approval process, completing it in a record 23 days — underscoring the urgency and commitment to improving access to innovative HIV prevention tools.
MCAZ Director-General Mr. Richard Rukwata highlighted the authority’s dedication to ensuring timely access to safe, effective, and high-quality medicines.
“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 and reinforces our commitment to safeguarding public health,” he said.
Brad Smith, Senior Advisor in the Bureau of Global Health Security and Diplomacy, described Lenacapavir as “an American innovation with the potential to avert nearly all new HIV infections when deployed at scale.”
The United States government, the Global Fund, and Gilead Sciences jointly confirmed the global rollout of the drug, noting that this marks the first time a new HIV medicine is reaching Sub-Saharan African countries in the same year it was approved in the U.S.
Health authorities and global health partners have hailed the move as a bold step in expanding prevention options, particularly for high-risk populations.
The rollout development was announced last Tuesday during a digital press briefing hosted by the U.S. Department of State’s Africa Regional Media Hub, where officials confirmed that African countries will receive 325,000 doses in 2026.
Eswatini received its shipment last Thursday and officially rolled out the drug on Tuesday, marking a significant step in its HIV prevention efforts. Zambia has also taken delivery of its first consignment, positioning the country to begin implementation soon.
Meanwhile, Gilead Sciences is finalising regulatory approvals and logistical arrangements to facilitate rollout Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, and Uganda.
Global Fund Executive Director Peter Sands said Zimbabwe’s strong performance with oral PrEP places it in an excellent position to adopt the new injectable.
“Zimbabwe has considerable experience with oral PrEP. Lenacapavir addresses adherence and stigma barriers seen with daily pills,” he said.
Zimbabwe continues to strengthen its HIV response under PEPFAR and Global Fund support, maintaining high levels of testing, treatment, and viral suppression. National HIV prevalence remains at approximately 11.6%, with adolescent girls and young women still disproportionately affected.
Health experts note that the twice-yearly injection aligns with global efforts to achieve the 95-95-95 targets—particularly in improving prevention for adolescent girls and young women aged 15–24, who account for most new HIV infections in Southern Africa.
Officials said the drug’s long-acting profile could dramatically reduce infections and accelerate global progress toward epidemic control. They also revealed that the U.S. government and the Global Fund have purchased the entire 2026 global production of 600,000 doses—an increase from an initial plan to procure just 500 doses.
Gilead has committed to scaling up production until generic manufacturers enter the market in 2027. CEO Daniel O’Day said the drug is being supplied to high-burden countries “at no profit,” describing the rollout as a milestone in advancing equitable access to life-saving medicines.
With global production projected to rise to 2 million doses by mid-2027, Zimbabwe is poised to become one of the key beneficiaries of this next-generation HIV prevention technology.
