UNAIDS executive director Winnie Byanyima speaking at a conference. Gilead recently presented data from the PURPOSE 1 trial of Sunlenca showing 100% prevention in cisgender women. Image credit: Shutterstock / Richard Juilliart

The UNAIDS executive director has called upon Gilead Sciences to make its ‘miracle’ drug lenacapavir for human immunodeficiency virus (HIV) prevention available to people from developing countries.

At the opening ceremony of the 25th International AIDS Conference (AIDS 2024), UNAIDS executive director Winnie Byanyima called upon the pharma giant to make the drug available to those who face violence for taking HIV medication.

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“Gilead you have a long-acting injectable lenacapavir. I call it a ‘miracle preventative’ tool. You have a miracle tool that could transform access for gay men, trans people, sex workers, for young women in Africa who could be freed from the stigma and fear of being attacked just for being seen swallowing tablets. Right now, Gilead, lenacapavir is priced for rich countries – this inequality never served us well in HIV response.”

Byanyima went on to say that Gilead’s drug comes with a $40,000 price tag in the US, adding that calculations have shown that a generic version of the drug could be developed for less than $100 per year in developing countries.

A Gilead spokesperson tells Pharmaceutical Technology: “While Gilead awaits additional Phase III clinical trial data and the potential regulatory filings for HIV prevention administered twice-yearly, it is too early to state the price of lenacapavir for PrEP (prevention). Our pledge is to price our medicines to reflect the value they deliver to people, patients, healthcare systems and society.”

“Gilead, make this happen now,” Byanyima added. “Grant generic licencing through the UN-backed Medicines Patent Pool and make generics available to all of Africa, Asia and Latin America.”

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There have been growing concerns that due to more strict bills being introduced against LGBTQI+ people in some sub-Saharan African countries, it will become even more difficult to access treatments and clinical trials in the HIV development landscape.

The Gilead spokesperson went to add that the company is exploring ways to deliver lenacapavir “swiftly, sustainably and in sufficient volumes, if approved, to high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries”.

The company plans to ensure supply where the need is greatest until voluntary licensing partners can provide high-quality, low-cost versions of lenacapavir, and develop a direct voluntary licensing program to expedite access to those versions of lenacapavir in high-incidence, resource-limited countries, said the spokesperson.

Last month, Gilead announced data from the PURPOSE-1 trial, showing lenacapavir, prevented 100% of HIV cases in cisgender women. The company will be announcing further data during AIDS 2024, which is being held between 22 – 26 July in Munich, Germany.

The US Food and Drug Administration (FDA) approved lenacapavir, in combination with an antiretroviral, for the treatment of HIV in heavily pretreated individuals who are failing current regimens due to resistance. The therapy is sold under the brand name Sunlenca for this indication.

The selection of high-incidence, resource-limited countries which will be eligible for high-quality, low-cost versions of LEN for PrEP is ongoing and we will provide information as soon as details are finalized, the Gilead spokesperson added.

The opening session of the conference was disrupted by a group of transgender activists, pleading for more trans inclusion before chanting ‘trans rights now’. The group’s protest was allowed by the conference, actor Annabelle Mandeng, who moderated the opening ceremony, adding that activists are welcome at AIDS 2024.

Also at the conference, a keynote speech from Christian Gaebler, professor at Charité, Universitätsmedizin, Berlin, will cover data from the seventh patient who has been ‘cured’ of HIV through a stem cell transplant.

Update: Sunlenca is the brand name for lenacapavir’s approved use as an HIV treatment for certain individuals. A previous version of this article incorrectly used the brand name to reference lenacapavir’s use as PreP regimen. Paragraphs 1, 3, 5, 9 have been updated

This article was updated to include comments from a Gilead spokesperson on 22 July.