Breakthrough HIV Drug Faces Access Barriers for Millions in Low-Income Countries

Lenacapavir, a twice-yearly injectable HIV prevention drug named Science Magazine's 2024 Breakthrough of the Year and recommended by WHO in July 2025, faces significant access barriers in low-income countries despite its revolutionary efficacy demonstrated in PURPOSE trials. Gilead Sciences signed royalty-free licenses with six generic manufacturers covering 120 countries in October 2024 and pledged non-profit supply for up to two million people, but rollout has been slow with only Zambia and Eswatini receiving shipments by November 2025. Médecins Sans Frontières' request for direct procurement was declined by Gilead in February 2026, with the company citing concerns about supply control and pricing spillover to high-income markets. Meanwhile, Indian regulators denied waivers for generic manufacturer Hetero, demanding full clinical trials including Indian-specific data, and UNAIDS warns that funding cuts could cause 6 million additional infections and 4 million deaths by 2029.

Lenacapavir's Clinical Breakthrough and WHO Recommendation

• ▪Lenacapavir was recommended by the World Health Organization in July 2025.
• ▪The PURPOSE 1 and PURPOSE 2 trials established very high efficacy for lenacapavir as twice-yearly injectable PrEP.
• ▪Lenacapavir was Science Magazine's 2024 Breakthrough of the Year.

Gilead's Phased Rollout Strategy and Voluntary Licensing Approach

• ▪Gilead Sciences' initial lenacapavir rollout would be organised through arrangements involving the Global Fund and PEPFAR.
• ▪Hetero, one of Gilead Sciences' voluntary licensees in India, sought waivers from the Central Drugs Standard Control Organisation for a bioequivalence study and for a local Phase III clinical trial for lenacapavir tablets 300 mg.
• ▪In October 2024, Gilead Sciences signed non-exclusive, royalty-free voluntary licenses with six generic manufacturers covering 120 high-incidence, resource-limited countries.
• ▪In March 2026, Gilead Sciences said it was open to an additional voluntary licence for local lenacapavir manufacturing in sub-Saharan Africa if quality standards are met.
• ▪Gilead Sciences was the first pharmaceutical company to formalise a licensing agreement with the Medicines Patent Pool in 2011.

MSF's Direct Procurement Request and Access Concerns

• ▪Following a meeting with Gilead Sciences in February 2026, Médecins Sans Frontières stated that Gilead Sciences had declined its direct procurement request.
• ▪In a subsequent open letter, Médecins Sans Frontières asked Gilead Sciences to clarify by 13 April whether direct sales would be allowed and on what pricing and supply terms.

Implementation Challenges and Limited Early Delivery

• ▪By March 2026, Eswatini had administered lenacapavir to around 2,000 people since December.
• ▪By March 2026, Eswatini was warning of pressure on lenacapavir stock availability following the initial surge in uptake.
• ▪In March 2026, a senior US State Department official said that Washington was looking for the next lenacapavir in tuberculosis.
• ▪The first lenacapavir shipments to Zambia and Eswatini occurred in November 2025.
• ▪Reports in May 2025 indicated that the broader lenacapavir rollout was expected to proceed gradually because of funding uncertainty and competing priorities.

Perspective of Gilead Sciences

• ▪Gilead Sciences' reluctance to allow Médecins Sans Frontières direct procurement rests on protecting tightly controlled supply channels to avoid diversion and parallel trade risks.

Perspective of UNAIDS

• ▪According to UNAIDS, funding cuts could result in an additional 6 million HIV infections by 2029, particularly among communities at greatest risk in high-burden settings.

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