A new analysis co-authored by Andrew Hill and featured in The Lancet shows that lenacapavir — a long-acting injectable for HIV prevention — could be produced for as little as $25 per person per year, potentially transforming global efforts to end the HIV epidemic.

Lenacapavir, administered just twice a year, has been shown to reduce HIV transmission to nearly zero. However, the drug’s high price remains a major barrier to access, with Gilead Sciences currently pricing it at over $28,000 per person annually in the US market. Hill and his colleagues’ work demonstrates that generic production costs are dramatically lower, paving the way for broader accessibility if patent barriers are overcome.

Updated Production Costs Reveal Opportunities for Widespread Access

The study, supported by the Make Medicines Affordable campaign, examined current prices of key starting materials and projected the cost of the active pharmaceutical ingredient using the most efficient synthesis routes. Factoring in formulation and a reasonable profit margin, the researchers estimate that lenacapavir could be manufactured and delivered for $35–$46 per year at a volume of two million treatments annually — and as low as $25 per year if scaled to five to ten million people.

Joseph Fortunak, the lead author and Professor at Howard University, along with Hill and a global team of researchers, emphasize the potential for lenacapavir to be a highly cost-effective intervention in the fight against HIV.

“We are at a moment where we could see the virtual elimination of HIV infections, but only if the drug is made affordable and widely available,” said Andrew Hill, Senior Visiting Research Fellow at the University of Liverpool and a leading advocate for HIV treatment access.

Licensing Deals Leave Millions Behind

While Gilead has signed voluntary licenses with only 3 generic manufacturers to supply low-cost lenacapavir to 120 lower-income countries, major regions with significant HIV burdens — such as parts of Eastern Europe, Central Asia, and most of Latin American countries — remain excluded. This leaves millions without access to this promising prevention tool.

“The licensing deals exclude some of the countries with the highest rates of new infections,” Hill warned. “Governments need to recognize that they have the power to negotiate fair prices or consider compulsory licenses to protect public health.”

Pricing Threatens Global HIV Prevention Efforts

Advocates and experts have described the current pricing as “utterly unaffordable” and a threat to public health. Professor Andrew Grulich from the Kirby Institute called Gilead’s pricing “absolutely crazy,” emphasizing that no health system can afford to implement lenacapavir widely at current prices.

“Prevention drugs must be priced to reach as many people as possible — they cannot be treated like luxury therapies,” Grulich stressed.

A Call for Urgent Global Action

The study by Hill and colleagues underscores the potential for generic lenacapavir to match or even undercut the price of existing oral PrEP regimens. With support from global health funders, pooled procurement strategies could help bring down costs and accelerate manufacturing at scale.

As Hill concluded: “Scientifically, lenacapavir is the closest thing we have to a vaccine for HIV. But without affordable access, this breakthrough risks becoming a public health tragedy rather than a triumph.”

This analysis calls on governments, civil society organizations, and global funders to take bold, collective action now — to demand fair pricing, remove patent barriers, and ensure that no one is left behind in the fight to end HIV.

The Lancet Preprint & Full Study

The full preprint, hosted by Preprints with The Lancet, outlines cost projections in detail and can be accessed here: Lenacapavir to Prevent HIV Infection: Updated Estimated Costs of Production for Generic Treatments