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Gilead Sciences, Inc. announced the delivery of first shipments of lenacapavir – Gilead’s twice-yearly injectable HIV-1 capsid inhibitor – for the prevention of HIV as pre-exposure prophylaxis (PrEP) to Eswatini and Zambia.
The deliveries advance ongoing efforts to accelerate equitable access to long-acting HIV prevention options across sub-Saharan Africa, which is home to approximately two-thirds of all people living with HIV globally.
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. Our work with the Global Fund, PEPFAR, governments, and many others, accelerates access and moves us closer to finally ending the HIV epidemic.
said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences.
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.
said Peter Sands, Executive Director of the Global Fund.
Through our America First Global Health Strategy, the Trump Administration is making targeted and high-impact investments in breakthrough health innovations like lenacapavir that will bend the curve of the HIV epidemic and help countries globally to break away from reliance on external health assistance. The United States is proud to champion this American biomedical achievement and, along with the Global Fund, to provide a catalytic investment to facilitate broad adoption globally.
said Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs and Religious Freedom.
The deliveries to Eswatini and Zambia demonstrate Gilead’s swift progress toward enabling sustainable, long-term availability of lenacapavir for PrEP in low- and lower-middle-income countries, if approved. Speed has been one of Gilead’s guiding principles, driving the company to introduce lenacapavir to the first sub-Saharan Africa countries just five months after U.S. FDA approval. Gilead anticipates product arrival in additional sub-Saharan Africa countries, including South Africa, in early 2026.
By the end of 2025, Gilead intends to complete regulatory submissions for lenacapavir for PrEP in 18 countries that represent approximately 70% of the HIV burden in the region covered by the company’s voluntary licensing agreements. In sub-Saharan Africa, lenacapavir for HIV prevention has been approved in South Africa and Zambia. Gilead has filed regulatory submissions so far in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda and Zimbabwe.
Gilead has secured royalty-free agreements with six generic manufacturers to cover 120 high-incidence, resource-limited countries that account for a large share of the global HIV burden. These agreements allow these manufacturers to seek regulatory approvals for their own generic versions of lenacapavir for PrEP and provide access in sufficient volumes to meet demand and generate competition to drive down costs. Gilead will supply lenacapavir at no profit for up to two million people until generic manufacturers are able to fully support demand in countries supported by the Global Fund and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) with the ability to produce additional supply to fulfill the needs of countries and global procurers.
Gilead remains deeply committed to delivering innovative, cost-effective solutions that strengthen global health security through initiatives to accelerate access to transformative HIV prevention tools like lenacapavir. By partnering with governments, advocacy groups and multilateral organizations to pursue the fastest paths to access, Gilead is working to ensure that lifesaving medicines reach those who need them most while fostering resilient health systems.
In middle-income countries with a high HIV burden that are not covered by Gilead’s voluntary licensing program and the agreements with the Global Fund and PEPFAR, Gilead is working with governments, regional bodies and partners to define and pursue the fastest paths to access.
Gilead will continue to provide updates on regulatory filings and other steps aimed at expanding access to lenacapavir for PrEP. We remain deeply engaged with stakeholders around the world, including community-based organizations, governments and multilateral organizations, to ensure that our access efforts help address the needs and preferences of the people and communities that could benefit from PrEP.
Lenacapavir for HIV prevention is not approved by any regulatory authority outside of U.S., EU, South Africa or Zambia. In Eswatini, lenacapavir was imported under an authorization issued by the Ministry of Health. This authorization was granted based on prior approval by a Stringent Regulatory Authority (SRA)—for example, the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) — and World Health Organization (WHO) Prequalification.
There is currently no cure for HIV or AIDS.
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