Highlights 

  • Gilead delivers its first twice-yearly lenacapavir shipments to Eswatini and Zambia. 
  • The move marks one of the fastest timelines from U.S. approval to African availability. 
  • Lenacapavir is designed as a long-acting PrEP option to help curb HIV transmission. 
  • Global Fund and PEPFAR partnerships are accelerating access pathways regionwide. 
  • Gilead aims to complete regulatory submissions covering 70% of Africa’s HIV burden by end-2025. 

Gilead Sciences, Inc. (Nasdaq:GILD) has taken a crucial step in global HIV prevention with the first deliveries of its twice-yearly injectable PrEP medicine, lenacapavir, to Eswatini and Zambia. These shipments signify an important moment for communities in sub-Saharan Africa, a region that accounts for nearly two-thirds of all people living with HIV worldwide. 

According to Gilead, this is the first time a new HIV medicine has reached sub-Saharan Africa within the same year as its U.S. approval, demonstrating unprecedented speed in access efforts. CEO Daniel O’Day highlighted that partnerships with the Global Fund, PEPFAR, and local governments have been central to accelerating rollout and supporting communities with high unmet need. 

Partners Call It a Transformational Moment 

Leaders across global health organizations emphasized the significance of these first arrivals. Peter Sands, Executive Director of the Global Fund, noted that seeing the medicine reach local medical stores underscores how innovation can translate into meaningful impact when communities are placed at the center of public health strategy. 

The U.S. government, through its America First Global Health Strategy, is supporting targeted investments in breakthrough health solutions like lenacapavir. Officials described this progress as part of a broader effort to help countries reduce reliance on external assistance by enabling access to next-generation medical tools. 

For Eswatini and Zambia, these first shipments signal the beginning of expanded availability of long-acting HIV prevention. Gilead anticipates the arrival of additional supplies in other sub-Saharan African countries, including South Africa, beginning in early 2026. 

A Comprehensive Access Strategy for the Region 

Gilead plans to complete regulatory submissions for lenacapavir for PrEP in 18 countries by the end of 2025—geographies that together account for 70% of the region’s HIV burden. The medicine is already approved for HIV prevention in South Africa and Zambia. Submissions have been filed in Botswana, Kenya, Malawi, Namibia, Rwanda, Tanzania, Uganda, and Zimbabwe. 

To scale access further, Gilead has established royalty-free agreements with six generic manufacturers covering 120 high-incidence, resource-limited countries. Under these agreements, generics will be allowed to pursue their own regulatory approvals and produce sufficient volumes once their products are ready. Until generics fully meet demand, Gilead will supply lenacapavir at no profit for up to two million people in countries supported by the Global Fund and PEPFAR. 

Lenacapavir’s multi-stage mechanism of action differentiates it from other antiviral classes, allowing it to inhibit HIV at several stages of its lifecycle. It is being studied in multiple clinical programs as both a standalone and combination of treatment, with the goal of expanding long-acting options tailored to individual needs. 

Conclusion 

The first shipments of twice-yearly lenacapavir to Eswatini and Zambia mark a meaningful advancement toward equitable access to HIV prevention in sub-Saharan Africa. Through coordinated efforts with governments, multilateral organizations, and community partners, Gilead is accelerating availability while laying out the foundation for sustainable long-term supply. As regulatory progress continues across the region, lenacapavir has the potential to reshape HIV prevention by offering a long-acting, community-aligned tool to help curb new infections. 

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