The promise of lenacapavir now depends less on science than on access.
Lenacapavir, an HIV drug that has been variously termed “a miracle”, “revolutionary”, “a game changer”, and “a turning point for HIV/AIDS”, has acquired an unusual place in the contemporary HIV response because it combines exceptional clinical promise with mounting global concern over access. It was Science Magazine’s 2024 Breakthrough of the Year and was recommended by the World Health Organization (WHO) in July 2025. This article examines the raging debate between Gilead Sciences and Médecins Sans Frontières (MSF) as a policy question, rather than as a dispute between a pharmaceutical company and an advocacy organisation. It explores Gilead’s position in favour of a phased and centrally managed rollout, the concerns raised by MSF regarding limited and delayed availability, and the extent to which the present arrangement is capable of serving vulnerable populations.
The attention surrounding lenacapavir arose from its unprecedented success in trials. The PURPOSE 1 and PURPOSE 2 trials established very high efficacy for twice-yearly injectable PrEP, leading to a recommendation from the World Health Organization (WHO). Requiring only two injections a year changes the operational terms of prevention for people whose engagement with health services is episodic and whose adherence to daily oral medication is shaped by stigma or instability, particularly those living in conditions that make regular contact with health services difficult. In policy terms, lenacapavir is a prevention option with the potential to alter programme design and user uptake in ways that daily oral regimens often cannot.
Gilead was the first pharmaceutical company to formalise a licensing agreement with the Medicines Patent Pool (MPP) in 2011, an organisation established to improve access to affordable, quality-assured medicines in low- and middle-income countries.
In October 2024, Gilead signed non-exclusive, royalty-free voluntary licenses with six generic manufacturers — a majority of them from India — covering 120 high-incidence, resource-limited countries. It subsequently announced that it would provide originator-supplied product to up to two million people on a non-profit basis until generic licensees are in a position to meet demand. The initial rollout would be organised through arrangements involving the Global Fund and PEPFAR, among other donors. Gilead presents this as a sequenced access strategy involving technology transfer, at-risk manufacturing, regulatory prioritisation, and a transition from limited originator supply to broader generic availability.
MSF has separately sought direct procurement of lenacapavir for its own country programmes, working with vulnerable populations. Following a meeting with Gilead in February 2026, MSF stated that the company had declined this request. In a subsequent open letter, it asked Gilead to clarify by 13 April whether direct sales would be allowed, and on what pricing and supply terms. MSF’s case is that humanitarian procurement should be permitted where national rollout pathways remain unavailable, delayed, or inadequate for the populations most at risk. Notably, Gilead was the first pharmaceutical company to formalise a licensing agreement with the Medicines Patent Pool (MPP) in 2011, an organisation established to improve access to affordable, quality-assured medicines in low- and middle-income countries. However, in the current negotiations, a speedy resolution seems unlikely unless either side makes concessions on the core issue of direct procurement.
For large pharmaceutical companies like Gilead, tiered pricing is one of the more commercially defensible ways of making a profit while preserving access in lower-income markets. According to analysts, Gilead’s reluctance to the MSF request appears to rest on the need to protect tightly controlled supply channels, since broader bilateral concessions could potentially increase the risks of diversion, parallel trade, and spillover effects on pricing negotiations in regulated high-income markets. At the same time, that commercial logic does not settle the access question, especially when the exclusion of many middle-income countries — including some that participated in the lenacapavir trials — raises ethical concerns and doubts about whether the model is sufficiently inclusive.
While Gilead says it has moved faster than in any previous access effort of this kind, the scale of access still falls short of the expectations created by lenacapavir’s own clinical success. Reports in May 2025 indicated that the broader rollout was expected to proceed gradually because of funding uncertainty and competing priorities. The first shipments to Zambia and Eswatini in November 2025 were symbolically important, but still limited in volume. By March 2026, reports suggested that Eswatini had administered lenacapavir to around 2,000 people since December and that the country was already warning of pressure on stock availability following the initial surge in uptake.
Reports in May 2025 indicated that the broader rollout was expected to proceed gradually because of funding uncertainty and competing priorities.
Initial trends indicate that a drug presented as potentially transformative has entered lower-income settings through a narrow and carefully gated set of channels, with actual delivery proceeding at a pace that remains modest relative to the enormous disease burden and the enthusiasm accompanying the drug. In March 2026, Gilead said it was open to an additional voluntary licence for local manufacturing in sub-Saharan Africa if quality standards are met. This appears to be the most plausible near-term outcome, as it preserves the company’s basic strategy while addressing some of the sharpest criticisms.
In parallel, Hetero, one of Gilead’s voluntary licensees in India, sought waivers from the Central Drugs Standard Control Organisation (CDSCO) for a bioequivalence study and for a local Phase III clinical trial in relation to lenacapavir tablets 300 mg. The Subject Expert Committee did not recommend those waivers, stating that Indian-subset clinical data had not been presented to rule out substantial ethnic variability and that the evidence was insufficient to establish dose adequacy in the Indian population. The committee minutes make clear that this arose in relation to lenacapavir tablets in the treatment setting for heavily treatment-experienced adults with multidrug-resistant HIV-1 infection, rather than the broader preventive rollout. Even so, the episode illustrates that voluntary licensing alone does not guarantee timely availability, because national regulatory requirements can be time-consuming.
In March 2026, it was reported that a senior US State Department official said that Washington was looking for “the next lenacapavir” in tuberculosis. That aspiration has unfolded alongside aid disruption, uncertainty over procurement arrangements, and broader concern about the stability of the HIV drug supply. Global health policy is searching for the next breakthrough in tuberculosis while still struggling to deliver the current one at a scale commensurate with epidemiological need and the expectations attached to the product.
Reports in May 2025 indicated that the broader rollout was expected to proceed gradually because of funding uncertainty and competing priorities.
According to UNAIDS, long-acting injectable HIV prevention has assumed greater importance at a moment when funding cuts could result in an additional 6 million HIV infections and 4 million AIDS-related deaths by 2029, particularly among communities at greatest risk in high-burden settings. This makes the rapid expansion of access to lenacapavir an ethical imperative.
While the current arrangement is defensible as a first-stage mechanism, it is not yet satisfactory as a public health response to a decades-old tragedy. Unless access broadens beyond tightly managed early pathways, lenacapavir will stand not only as a major scientific advance but also as a reminder that the institutions of global health remain slower, narrower, and less adaptive than the science they now celebrate.
Oommen C. Kurian is Senior Fellow and Head of the Health Initiative at the Observer Research Foundation.
Disclosure: In the past, the Observer Research Foundation has received funding from Gilead Sciences. This piece was written without direction from any funder, and the views expressed are those of the author alone.
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Oommen C. Kurian is Senior Fellow and Head of the Health Initiative at the Inclusive Growth and SDGs Programme, Observer Research Foundation. Trained in economics and ...
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