US Government, Global Fund Secure 600,000 Doses of Lenacapavir in 2026, Targeting 2 Million by Mid-2027

November 18, 2025 — The United States Government, in collaboration with Gilead Sciences and the Global Fund to Fight AIDS, Tuberculosis, and Malaria, announced a significant acceleration in the delivery of the breakthrough HIV prevention injection, Lenacapavir, committing to reserving 100 percent of the available 2026 supply for high-burden countries in Africa.

The announcement was made during a digital press briefing on November 18, 2025, detailing the implementation of the America First Global Health Strategy and the commitment to substantially reduce new HIV infections globally.

Procurement and Supply Data

The partnership’s procurement target for Lenacapavir is 2 million doses. This total commitment is anticipated to be met sometime in mid-2027, or hopefully before.

For the initial phase, Year 1 (2026), Gilead Sciences has an available volume of 600,000 doses. Due to early signs of demand, the U.S. commitment alone was increased from an initial 250,000 doses to 325,000 doses. The Global Fund and the U.S. Government together have reserved 100 percent of the 600,000 doses available in 2026. The two entities are coordinating closely, generally splitting the procurement approximately 50/50.

The initial rollout of Lenacapavir, an American innovation that requires administration only twice a year, is starting in 10 countries in Africa.

Breakthrough Efficacy

Lenacapavir is described by the sources as a new, highly effective HIV prevention injection with the potential to avert nearly 100 percent of new HIV infections.

Data from clinical trials demonstrates extremely high efficacy and tolerability:

• One study (Purpose 1 trial), which included thousands of women and girls in Africa, showed 100 percent effectiveness at preventing HIV in that population.
• A second study (Purpose 2 trial) showed 99 percent of people did not contract HIV.
• The medicine has been studied in large clinical trials across every population that could benefit from PrEP and has been shown to have very good tolerability with no addictive properties.

The trials included a specific focus on Sub-Saharan Africa, where women aged 15 to around 24 account for more than two-thirds of new HIV infections.

Eswatini Rollout Data

The first purchases and deliveries of Lenacapavir are taking place in the Kingdom of Eswatini. Eswatini was chosen as it is the country with the highest incidence of HIV in the world and has been among the most affected by the virus.

Specific data points related to Eswatini include:

• At the peak of the epidemic in 2015, almost one out of three people were living with HIV.
• Recent estimates indicate 220,000 people are living with HIV in Eswatini.
• Eswatini has surpassed the 95-95 targets, with a remarkable 98 percent of people living with HIV on treatment.
• PEPFAR, the U.S. Government program, currently funds treatment for 216,000 of these individuals, accounting for over 95 percent of the people in Eswatini receiving treatment.
• The new Lenacapavir programming will initially support over 6,000 people at high risk of HIV in Eswatini, focusing on eliminating mother-to-newborn transmission.

Sustainability and Generic Access

To ensure a sustainable model, Gilead Sciences is providing Lenacapavir at no profit to the countries with the highest burden of HIV.

Furthermore, Gilead voluntarily licensed the product to six generic manufacturers before filing for U.S. regulatory approval and technology transferred the product to them. Generic manufacturers are anticipated to begin supplying markets as early as 2027. This transition to generics is crucial for a sustainable model that offers a significantly reduced cost for countries over time.