Global Fund plans for lenacapavir PrEP in selected countries

Simon Collins, HIV i-Base

On 9 July 2025, the Global Fund and Gilead Sciences announced details of plans to make lenacapavir available as a six-monthly injection in selected low- and middle-income countries (LMICs). [1, 2]

The Global Fund plans for their programme to reach two million people with long-acting PrEP. The first stage of this goal includes having signed a licensing contract with the manufacturer Gilead to provide lenacapavir until generic companies are able to produce lower-priced versions.

Although early access will be decided both on a country’s needs and the available resources, these essential details are not reported. However, the timeline includes providing lenacapavir to at least one African country before the end of 2025.

The press release also refers to working with private donors to roll out this programme including UNITAID, the Elton John AIDS Foundation (EJAF), AVAC and the Children’s Investment Fund Foundation (CIFF).

Last month, Bill Gates also publicly committed to support lenacapavir PrEP. [3]

It also suggests that there is still much to be done to ensure appropriate funding will be available and that the Global Fund itself is not able to guarantee this:

“Without urgent and sustained investments the ambition to reach 2 million people with long-acting PrEP risks falling short — just as the world stands at the brink of a decisive step toward ending AIDS for good”.

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This is good news but funding commitments and more details are essential in order to balance realistic expectations.

Access will also depend on Gilead registering lenacapavir widely in all countries and previous announcements on access have not included many high-incidence countries in Central and South America, including those where registration studies for lenacapavir were held.

Health Gap, together with other HIV activist organisations, highlighted the permanent secrecy imposed on the Global Fund as part of the agreement and the lack of transparency about pricing. Also that the countries invited to take part are South Africa, Eswatini, Lesotho, Mozambique, Kenya, Uganda, Zambia and Zimbabwe. [4]

Asia Russell, Executive Director, Health GAP said: “Coming on top of Trump and Rubio’s anti-science and anti-HIV funding cuts, Gilead’s greed has created an unprecedented, coordinated global regime of lenacapavir-LA price secrecy that violates our basic rights and will undermine global access. We demand price transparency from Gilead and the Global Fund.”

Similarly, MSF emphasised that the potential of lenacapavir was dependent on access:included: “Gilead is paying lip service to equity and access while imposing restrictions on potential generic producers that will minimise scale-up of this game-changing drug while protecting and maximising its profits.” [5]

Details for why transparency over the price that Gilead is charging the Global Fund is important is covered in a detailed report about South Africa. [6]

Since 20 January 2025, the withdrawal of US international funding has led to the closure of thousands of clinics in LMICs that provided sexual health services for key populations.

This meant that many basic services like condoms, lube and oral PrEP disappeared overnight. Showing the urgency of restoring even these basic services will be essential to provide the framework for programmes for injectable PrEP.

The importance of re-establishing HIV prevention as an urgent priority is also stressed in the recent Kigali Call to Action, launched to coincide with the upcoming IAS conference in Rwanda next week. [7]

Two million is a good start but access really needs to reach ten million people for lenacapavir to have the potential to end new transmissions by 2030. But just like the WHO 3×5 Campaign on access to ART, we needed to get past the first few million to reach the 30 million people currently on treatment globally.

References

The Global Fund to Fight AIDS Tuberculosis and Malaria (the Global Fund). Global Fund Secures Access to Breakthrough HIV Prevention Drug Lenacapavir for Low- and Middle-Income Countries. (9 July 2025).
https://www.theglobalfund.org/en/news/2025/2025-07-09-global-fund-secures-access-breakthrough-hiv-prevention-drug-lenacapavir
Gilead press statement. Gilead Finalizes Agreement With the Global Fund to Accelerate Access to Twice-Yearly Lenacapavir for HIV Prevention for up to Two Million People in Primarily Low- and Lower-Middle-Income Countries. (9 July 2025).
https://www.gilead.com/news/news-details/2025/gilead-finalizes-agreement-with-the-global-fund-to-accelerate-access-to-twice-yearly-lenacapavir-for-hiv-prevention-for-up-to-two-million-people-in-primarily-low–and-lower-middle-income-countries
Gates Foundation commits to providing lenacapavir as PrEP next year. HTB (3 June 2025).https://i-base.info/htb/51222
Health GAP. Gilead Imposes Price Secrecy on Global Fund Over Breakthrough HIV Prevention Shot, Blocking Transparency and Accountability. (9 July 2025).
https://healthgap.org/press/gilead-imposes-price-secrecy-on-global-fund-over-breakthrough-hiv-prevention-shot-blocking-transparency-and-accountability/
MSF press release. WHO-recommended lenacapavir could offer a path toward an HIV-free world, but only if people can access it. (14 July 2025).
https://www.doctorswithoutborders.org/latest/who-recommended-lenacapavir-could-offer-path-toward-hiv-free-world-only-if-people-can-access
Bhekisisa. SA gets R520-million to buy the twice-a-year anti-HIV jab — but there’s a snag. (15 July 2025),
https://bhekisisa.org/health-news-south-africa/2025-07-15-sa-gets-r520-million-to-buy-the-twice-a-year-anti-hiv-jab-but-theres-a-snag/
Kigali Call to Action: sign-on for IAS 2025 conference, HTB (1 July 2025).
https://i-base.info/htb/51418