By: IPP Bureau
Last updated : November 25, 2025 7:09 pm
The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval
US-based biopharma giant Gilead Sciences has shipped the first doses of lenacapavir, a twice-yearly injectable HIV prevention drug, to Eswatini and Zambia. This marks a major milestone in the fight against HIV in sub-Saharan Africa.
The deliveries bring the innovative medicine to communities heavily impacted by HIV just five months after U.S. FDA approval, underscoring Gilead’s commitment to rapid, equitable access. Sub-Saharan Africa is home to roughly two-thirds of the world’s HIV-positive population.
“Lenacapavir’s arrival in Eswatini and Zambia is a historic moment for HIV prevention,” said Daniel O’Day, Gilead CEO. “For the first time, a new HIV medicine is reaching communities here in the same year as its U.S. approval. Working with the Global Fund, PEPFAR, and local governments, we’re moving closer to ending the HIV epidemic.”
Peter Sands, Executive Director of the Global Fund, hailed the rollout as transformational. “Seeing health workers trained and first doses arrive shows how innovation can translate into real impact for at-risk populations. When communities lead, progress becomes sustainable.”
Gilead is also enabling long-term access through royalty-free agreements with six generic manufacturers, covering 120 high-HIV-incidence countries. The company will provide the drug at no profit for up to two million people until generic production scales up.
By the end of 2025, Gilead plans regulatory submissions for lenacapavir in 18 countries representing about 70% of the HIV burden in the region. Already approved in South Africa and Zambia, submissions are underway in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda, and Zimbabwe.
“This is a new era in HIV prevention,” said Jeremy Lewin, US senior foreign assistance official, highlighting American support for breakthrough health innovations that reduce global reliance on external aid.
Gilead’s efforts reflect a strategy focused on speed, scale, and sustainability, aiming to ensure lifesaving HIV prevention reaches those who need it most, while strengthening health systems across sub-Saharan Africa.