Long-acting injectable PrEP approved in the US: priced at $28,000 a year

Simon Collins, HIV i-Base

On 18 June 2025, the US FDA approved a long-acting injectable version of PrEP that is highly effective and only needs to be taken every six months. [1]

Lenacapavir is a new version of PrEP that was highly effective in two large international phase 3 studies. There were zero new HIV cases in the PURPOSE 1 study (vs 16 cases in the oral TD/FTC arm) and only two new cases in the PURPOSE 2 study (vs nine in the oral PrEP arm).

Each study included thousands of participants over several years. Importantly, 6-8% of people looking to enrol in these studies were already found to already be HIV positive. So the interest and demand from people wanting long-acting PrEP had an additional health benefit of earlier HIV diagnoses.

Everything now depends on access, which depends on price.

The US list price is $14,109 for one injection and $28,218 annually.

Although the manufacturer, Gilead Sciences, is working with selected generic manufacturers to enable generic versions of lenacapavir to be available in 120 low- and middle-income countries, these agreements do not cover all the countries that contributed sites for the phase 3 studies.

The likely price for generic lenacapavir has not yet been released, and this will be dependent on funder commitments to volume orders. However, this is expected to be significantly higher than the annual prices of around $40 modelled by independent experts. This might even drop to as low as $25 per year. [3]

Lenacapavir is marketed by Gilead Sciences with the brand name Yeztugo.

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Lenacapavir for PrEP is a remarkable breakthrough, but this price will effectively block the considerable promise to end new HIV transmissions. There is no point in being “the first and only” anything if access is so limited.

Based on this astronomical US price it appears cheaper to become HIV positive and take ART than it would be to use lenacapavir to remain HIV negative. It is also sobering that lenacapavir is priced slightly lower than the annual $36,000 for oral TAF/FTC (Descovy).

However, the impact of lenacapavir on a population level depends on broad access and uptake, with similar coverage to a vaccine programme. Unless access programmes enable broad roll-out to all populations at risk of HIV, it will just be a top-shelf novelty for those with the least need.

Although Gilead announced that the company will be providing lenacapavir at a “no-profit” price in 120 high-incidence resource-limited countries until generic formulations become available, no details about the price or these volumes have been disclosed. [2]

The latest independent study to model the potential annual price for generic lenacapavir reported that this could drop to as low as $25 per person. [3]

Winnie Byanyima, Executive Director of UNAIDS said: “If this game-changing medicine remains unaffordable it will change nothing. I urge Gilead to do the right thing. Drop the price, expand production and ensure the world has a shot at ending AIDS.” [4]

References

Yeztugo (Lenacapavir) is now the first and only FDA-approved HIV prevention option offering 6 months of protection. (18 June 2025).
https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection
Gilead Sciences. Gilead Statement on Access Planning for Lenacapavir for HIV Prevention in Low- and Middle-Income Countries. (18 June 2025).
https://www.gilead.com/company/company-statements/2025/gilead-statement-on-access-planning-for-lenacapavir-for-hiv-prevention-in-low–and-middle-income-countries
Fortunak JM et al. Lenacapavir to Prevent HIV Infection: Updated Estimated Costs of Production for Generic Treatments. Lancet HIV preprint. (18 June 2025).
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5293409
UNAIDS. UNAIDS urges Gilead to drop price of new HIV prevention shot. (18 June 2025).
https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2025/june/20250618_lenacapavir

This report was first published on 28 June 2025,