November 18, 2025 — Leads & Copy — Gilead Sciences, Inc. (Nasdaq: GILD) has begun delivering its twice-yearly injectable HIV-1 capsid inhibitor, lenacapavir, to Eswatini and Zambia for HIV prevention as pre-exposure prophylaxis (PrEP). These shipments aim to increase equitable access to long-acting HIV prevention methods in sub-Saharan Africa, where approximately two-thirds of all people living with HIV reside.
Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences, stated that the arrival of lenacapavir doses in Eswatini and Zambia marks a significant milestone in HIV prevention. He emphasized Gilead’s commitment to supporting communities with the greatest need and noted that this is the first time a new HIV medicine is reaching sub-Saharan Africa in the same year as its U.S. approval. O’Day also acknowledged the collaborative efforts with the Global Fund, PEPFAR, governments, and other organizations to accelerate access and move closer to ending the HIV epidemic.
Peter Sands, Executive Director of the Global Fund, highlighted the transformative nature of this moment after witnessing the arrival of the first lenacapavir boxes at Central Medical Stores and observing health workers being trained to administer the drug. He expressed the Global Fund’s pride in countries gaining firsthand experience with a product representing a new era in HIV prevention. Sands emphasized the importance of rapidly reaching at-risk populations at scale, stating that innovation becomes impact and progress becomes sustainable when communities are at the center.
Jeremy Lewin, Senior Official for Foreign Assistance, Humanitarian Affairs and Religious Freedom, stated that the Trump Administration is investing in breakthrough health innovations like lenacapavir through the America First Global Health Strategy. Lewin said that these investments will help countries globally to break away from reliance on external health assistance. He also noted that the United States is proud to champion this American biomedical achievement and, along with the Global Fund, provide a catalytic investment to facilitate broad adoption globally.
Gilead’s deliveries to Eswatini and Zambia are swift steps toward enabling sustainable, long-term availability of lenacapavir for PrEP in low- and lower-middle-income countries, pending approval. The company introduced lenacapavir to sub-Saharan Africa just five months after U.S. FDA approval and anticipates product arrival in additional countries, including South Africa, in early 2026.
Gilead plans to complete regulatory submissions for lenacapavir for PrEP in 18 countries by the end of 2025, representing approximately 70% of the HIV burden in the region covered by its voluntary licensing agreements. Lenacapavir for HIV prevention has already been approved in South Africa and Zambia. Regulatory submissions have also been filed 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 manufacturers to seek regulatory approvals for their own generic versions of lenacapavir for PrEP, providing access in sufficient volumes and generating competition to drive down costs. Gilead will supply lenacapavir at no profit for up to two million people until generic manufacturers can fully support demand in countries supported by the Global Fund and PEPFAR, with the ability to produce additional supply as needed.
Gilead is committed to delivering innovative, cost-effective solutions to strengthen global health security by accelerating access to transformative HIV prevention tools like lenacapavir. The company partners with governments, advocacy groups, and multilateral organizations 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 not covered by Gilead’s voluntary licensing program and 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 to expand access to lenacapavir for PrEP and remains engaged with stakeholders worldwide to ensure that access efforts address the needs and preferences of people and communities that could benefit from PrEP.
Lenacapavir for HIV prevention is not approved by any regulatory authority outside of the U.S., EU, South Africa, or Zambia. In Eswatini, lenacapavir was imported under an authorization issued by the Ministry of Health, based on prior approval by a Stringent Regulatory Authority (SRA) and World Health Organization (WHO) Prequalification.
There is currently no cure for HIV or AIDS.
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Source: Gilead Sciences, Inc.
