Newsletter Edition #379 [The Files In-Depth] 

Readers,

Few stories capture global health in all its complexity where science, politics and the economics come together to show the multi-faceted nature of the field.

In today's story, my colleague Shubhangi Thakur brings you the evolving the picture around the HIV preventive drug Lenacapavir.

This expansive edition (4,000 words +), discusses how HIV prevention strategy is being shaped by the mechanics of voluntary licensing. The story is unfolding in an era of transition: what does it mean for countries to decide on their own prevention strategies. The cast is diverse and powerful, captures the layered interests in global health.

Months in the making, we have tried to stitch together as many aspects as possible. Write to us with your feedback. Thakur is a part of our annual fellowship program this year.

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Best,

Priti

Priti Patnaik, Founder & Publisher, Geneva Health Files

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Presenting our weekly in-depth analysis on global health that captures the big picture and the nuances like no one else does. This is an exclusive edition for our subscribers.

I. GHF ANALYSIS

The Illustrative Case of Lenacapavir: The Gatekeepers of Prevention, Access & Financing

By Shubhangi Thakur

Priti Patnaik contributed to this story

Few medicines in global health have arrived with as much promise, and as much unresolved debate about access, as lenacapavir, a preventive drug to treat the infection caused by Human Immunodeficiency Virus (HIV).

Developed by Gilead, lenacapavir (LEN) is the first HIV capsid inhibitor to be used for prevention. It is administered as a subcutaneous injection every six months, reducing the need for daily pills and frequent clinic visits. (It works as an antiviral that targets HIV’s protective shell and stops the virus from copying itself and multiplying.)

The efficacy data have strengthened expectations around the drug. In the PURPOSE 1 trial, no participants receiving lenacapavir acquired HIV, corresponding to 100% efficacy against HIV acquisition. PURPOSE 2, which enrolled cisgender men and transgender and non-binary participants across seven countries, found a 96% reduction in HIV incidence compared with background incidence. The PURPOSE program continues testing the drug across populations and dosing schedules, including a potential once-yearly formulation.

The regulatory pathway has also moved quickly. The FDA approved injectable lenacapavir for prevention in June 2025, and the WHO recommended it the following month as an additional prevention option, urging countries to begin building the systems needed for wider access.

Together, the evidence raises the prospect of a prevention tool that could sidestep the adherence, stigma and service-contact barriers that have limited the adoption of daily Pre-exposure prophylaxis (PrEP). (PrEP is used as a preventive strategy to administer antiviral drugs to reduce the risk of getting HIV.)

However, the promise of lenacapavir raises a harder question: can health systems actually get it to the people who need it, at the scale the epidemic demands?

The Economics of Voluntary Licensing

A voluntary license is an agreement in which a patent holder authorizes selected manufacturers to produce and sell a generic version of a patented medicine, on terms — territory, timing, sourcing — that the patent holder sets. It differs from compulsory licensing, in which a government determines that public-health circumstances justify authorizing production or importation without the patent holder's consent, a mechanism preserved under the WTO's TRIPS framework and the Doha Declaration. It also differs from licensing brokered through the Medicines Patent Pool (MPP). The MPP is a mechanism for negotiating and administering voluntary licenses. It negotiates licenses as determined mutually with patent holders. And then sub-licenses it to multiple generic manufacturers under negotiated terms subject to conditions and geographic scope agreed with the patent holder.

Gilead was the MPP's first pharmaceutical partner in 2011 and has since licensed several HIV medicines through the pool, including tenofovir and emtricitabine. For lenacapavir, Gilead chose the bilateral route. For lenacapavir, Gilead did not work through MPP. (Queries sent to MPP went unanswered.)

On October 2, 2024 — months before the drug had regulatory approval for prevention anywhere — it granted non-exclusive, royalty-free licenses to six manufacturers, covering 120 high-incidence, resource-limited countries.

Gilead told us that this was part of an effort to move access planning ahead of regulatory filing, describing the expansion of global access to twice-yearly lenacapavir as a priority and saying it had moved with unprecedented speed to translate innovation into access.

Early licensing allowed manufacturers to begin generic production before approval but that did not create an unrestricted market for generic lenacapavir. Each manufacturer can supply only within the territories covered by its agreements.

That distinction between enabling generic production and defining where generic competition can occur is central to the economics of the license.