Lenacapavir approved as long-acting injectable PrEP in the US but at an astronomical price

28 June 2025. Related: Early access, Antiretrovirals, HIV prevention and transmission.

Simon Collins, HIV i-Base

On 18 June 2025 the US FDA approved a long-acting injectable version of PrEP that only needs to be taken every six months.

Lenacapavir is highly effectivein the large international phase 3 studies. There were zero new HIV cases in the large phase 3 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).

Everything now depends on price, which has so far not been announced.

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

The US list price is $14,109 for one injection and $28,218 for a year’s cover.

Although Gilead is working with selected generic manufacturer’s to produce versions for some low- and middle-income countries, these agreements do not even cover all the countries that contributed sites for the phase 3 studies. 

No price for generic lenacapavir has been released although this is expected to be significantly higher than the best projected prices based on independent models.
 

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Lenacapavir is a remarkable breakthrough, but this price will effectively block the considerable promise to end new HIV transmissions. Based on this price it appears cheaper to become HIV positive and take ART.

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 

  1. 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
  2. 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
  3. Fortunak JM et al. Lenacapavir to Prevent HIV Infection: Updated Estimated Costs of Production for Generic Treatments. Lancet HIV pree press. (18 Jun 2025).
    https://papers.ssrn.com/sol3/papers.cfm
  4. NAIDS. UNAIDS urges Gilead to drop price of new HIV prevention shot. (18 Jun 2025).
    https://www.unaids.org/en/resources/presscentre/pressreleaseandstatementarchive/2025/june/20250618_lenacapavir

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