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Gilead’s Lenacapavir Plan Faces Global Hurdles As It Commits To No-Profit Access for 2 Million – Gilead Sciences (NASDAQ:GILD)

Gilead Sciences, Inc. GILD on Wednesday announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria to supply lenacapavir — Gilead’s twice-yearly injectable HIV-1 capsid inhibitor — for the prevention of HIV as pre-exposure prophylaxis (PrEP).

Through the agreement, Gilead will supply enough doses to reach up to two million people over three years in countries supported by the Global Fund, at no profit to Gilead.

In June, the U.S. Food and Drug Administration (FDA) approved Yeztugo (lenacapavir) as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents weighing at least 35kg, making it the first and only twice-yearly option available in the U.S. for people who need or want PrEP.

Yeztugo’s annual list price in the U.S. before insurance is $28,218.

A month’s supply of Truvada and Descovy, Gilead’s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year.

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The drug was praised as the closest thing to a vaccine and a powerful tool to help control the 45-year-old HIV pandemic. However, advocates and researchers were concerned that the people most affected — especially in low-income countries — might not get access to it, especially after the Trump administration started reducing foreign aid, the STAT news wrote.

In October 2024, Gilead signed non-exclusive, royalty-free voluntary licensing agreements to manufacture and supply high-quality generic versions of lenacapavir in 120 high-incidence, resource-limited countries, primarily low- and lower-middle-income countries (LLMICs).

Until licensed generic versions are available and can fully meet demand in LLMICs, Gilead also committed to providing Gilead-supplied lenacapavir for PrEP at no profit.

Under this strategic partnership agreement with the Global Fund, countries supported by the Global Fund that are among the 120 high-incidence, resource-limited countries can access lenacapavir for PrEP.

STAT News writes that the deal does not cover the U.S. government’s PEPFAR program, which has been the top global supplier of HIV prevention drugs.

In December 2024, PEPFAR said it would work with three other organizations to speed up the drug’s rollout. However, those plans were disrupted when the Trump administration made major cuts to foreign aid, creating uncertainty around PEPFAR’s future and related agreements.

The situation raises lingering questions, especially about the Biden administration’s plans for PEPFAR, a key U.S. global health program. Trump’s 2026 budget proposal includes a $1.9 billion cut to the program.

Meanwhile, whether the Global Fund can afford to buy the doses independently is uncertain. Although the group has spent over $65 billion fighting infectious diseases since 2002, it’s facing funding challenges. PEPFAR has historically been a major source of its budget, and other wealthy nations have also reduced their foreign aid contributions in recent years.

GILD Price Action: GILD stock is up 1.26% at $112.46 at publication on Wednesday.

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