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Gilead Sciences, the American biopharmaceutical company, has announced that Eswatini and Zambia have received the first shipments of its breakthrough HIV prevention drug, lenacapavir. The deliveries mark a major milestone in the global fight against HIV—a virus that has claimed millions of lives worldwide and continues to disproportionately affect communities across sub-Saharan Africa.

“The arrivals of the first doses of lenacapavir in Eswatini and Zambia mark an important milestone in HIV prevention and reflect our commitment to supporting communities with the greatest need. For the first time, a new HIV medicine is reaching communities in sub-Saharan Africa in the same year as its U.S. approval,” said Daniel O’Day, CEO of Gilead Sciences.

About Lenacapavir

Lenacapavir is a long-acting injectable HIV capsid inhibitor approved for pre-exposure prophylaxis (PrEP) in adults and adolescents at high risk of HIV infection. Administered just twice a year, the drug is expected to significantly improve adherence—a persistent challenge with existing daily or frequent-dose PrEP options. Its dosing schedule positions it as one of the most promising tools in reducing new HIV infections globally.

A Transformational Moment

Global Fund Executive Director Peter Sands welcomed the milestone with optimism, underscoring the broader implications for HIV prevention efforts in the region.

“Seeing the first boxes arrive at Central Medical Stores, and then meeting the health workers being trained to administer lenacapavir, reinforced just how transformational this moment is. The Global Fund is proud to see countries gaining firsthand experience with a product that represents a new era in HIV prevention. The real impact will come from rapidly reaching the most at-risk populations at scale. If communities are at the center, innovation becomes impact, and progress becomes sustainable,” he stated.

According to Gilead, the consignments to Eswatini and Zambia reflect the company’s progress toward establishing sustainable, long-term access to lenacapavir for PrEP in low- and lower-middle-income countries—pending regulatory approval. The company fast-tracked distribution to these first countries in sub-Saharan Africa within five months of receiving U.S. FDA approval, an unprecedented pace in HIV drug rollout.

Gilead expects lenacapavir to reach additional countries in the region—including South Africa—beginning in early 2026.

Regulatory Momentum in Africa

Lenacapavir for HIV prevention has already been approved in South Africa and Zambia. Gilead has also submitted regulatory filings in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda, and Zimbabwe, signaling growing momentum across the continent.

To ensure wide and affordable access, Gilead has entered into royalty-free agreements with six generic manufacturers covering 120 high-incidence, resource-limited countries that bear a substantial share of the global HIV burden. These agreements enable partners to pursue regulatory approvals for their own generic versions of lenacapavir for PrEP, ensuring sufficient supply, promoting market competition, and ultimately driving down costs.

In the interim, Gilead has committed to supplying lenacapavir at no profit for up to two million people until generic manufacturers can fully meet demand across countries supported by the Global Fund and PEPFAR, with capacity to expand access even further.