Gilead Urged to Expand Voluntary Licences for its Breakthrough HIV Treatment 
HIV and AIDS 03/10/2024 •
Lenacapavir, packaged as Sunlenca in the US, where is sells for $42,250 for two injections.

HIV activists have hailed the announcement by Gilead on Wednesday that it has authorised six generic manufacturers to sell its breakthrough HIV treatment, lenacapavir, in 120 low- and middle-income countries. 

However, they have urged Gilead to expand the deal to include countries such as Brazil, Colombia and Mexico.

Lenacapavir is a long-acting injectable drug that has proven 100% successful in preventing HIV in women who received it twice a year, and almost 100% protective for men and gender minorities who have sex with men in clinical trials.

Results of the PURPOSE1 trial involving women were presented at the International AIDS conference in Munich in July, receiving a standing ovation.

In late September, results from the PURPOSE2 trial reported 99% success rate for the drug as pre-exposure prophylaxis (PrEP).

While lenacapavir is not yet authorised in many countries, it is licensed in the US as Sunlenca for people with drug-resistant HIV, and costs $42,250 a year for two injections.

A wide range of organisations, including UNAIDS, called on Gilead to lower costs and license generic companies to produce the injection. The company undertook to do so at a media briefing at the AIDS conference in July, 

On Wednesday, Gilead CEO Daniel O’Day announced it had signed voluntary licencing deals with the six generic companies to produce lenacapavir. Four of the companies are from India: Reddy’s Laboratories, Hetero Pharma, Emcure and Mylan (a subsidiary of Viatris). Egypt’s Eva Pharma and Pakistan’s Ferozsons Laboratories are also part of the deal.

“Given the transformative potential of lenacapavir for prevention, our focus is on making it available as quickly and broadly as possible where the need is greatest,” said O’Day.

“Gilead teams have been working with urgency to bring on high-volume generic manufacturers now, so that we can ensure a rapid transition to these voluntary licence partners after lenacapavir for PrEP is approved.”

Most of South America excluded

Activists at the International AIDS conference protesting against the high price of lenacapavir.

Public Citizen’s access to medicines director Peter Maybarduk said Gilead had “heard the call in part” from people living with HIV and allies worldwide to make lenacapavir “available for global, timely affordable supply, by licensing developing country manufacturers”.

“Its licence will help ensure access to needed treatment for many people and countries. But it leaves out others, including most of South America, where communities continue to fight against real challenges for access,” Maybarduk added.

“Gilead will continue to control who sells lenacapavir and where, through restrictive licensing terms, which will limit availability of affordable lenacapavir even where Gilead claims no patents.”

Public Citizen would have preferred Gilead to license the Medicines Patent Pool, which “would have helped Gilead reach as many people as possible through equitable access terms and brought added credibility”. 

UNAIDS applauded Gilead for licensing the generic companies – including one on the African continent – without waiting for registraion.

“Lenacapavir, which requires only two injections per year, could be game changing – if all who would benefit can access it,” noted UNAIDS.

However, it said that 41% of new HIV infections are in upper-middle income countries, so the “exclusion of many middle-income countries from the licenses is deeply worrying and undermines the potential of this scientific breakthrough”.

UNAIDS also welcomed Gilead’s statement of commitment to “non-profit pricing”, and urged the company to name a specific price.

“Respected researchers have shown it is possible to produce and sell lenacapavir for $100 per patient per year, falling to as little as $40,” it noted.

HIV advocacy organisation AVAC welcomed the speedy issuing of the licenses and the fact that the generic companies come from three different countries, but noted that “key countries with significant HIV incidence, including several of those hosting the PURPOSE 2 trials of lenacapavir” had been left out.

“This challenges the field’s ability to use this new option at the scale needed to drive down HIV incidence as quickly as possible to meet global targets,” said AVAC, noting that the price of lenacapavir is “still unknown”.

Untaid ‘prepared to invest immediately’ in generics

Meanwhile, Unitaid welcomed the announcement, adding that it is “prepared to invest immediately and collaborate to fast-track access to lenacapavir”.

Unitaid, an initiative hosted by the World Health Organization (WHO) that promotes equitable access to treatment for key global diseases, said it was ready to assist the six generic companies that have been licensed.

“This is a potentially game-changing medication that could dramatically turn the tide against HIV infections, and we must ensure, without delay, global access to lenacapavir for all those who need it,” said Dr Philippe Duneton, Unitaid’s executive director. 

Duneton urged Gilead to “expand its licensing framework to include all populations in need, clarify its plans for registration in all trial countries, and provide a clear timeline for when lenacapavir will be accessible in the countries it promises to serve”.

Brazil was one of the countries that hosted the PURPOSE trials and “cannot be excluded from licensing agreements, and registration plans,” noted Unitaid.

Unitaid, working with the Wits RHI (South Africa) and Clinton Health Access Initiative (CHAI), will soon launch an Expression of Interest for generic lenacapavir licensees to for support for “the accelerated development, regulatory filing, commercialisation, and cost-effective launch pricing for generic lenacapavir”. 

It also urged Gilead to ensure an access strategy that is “transparent, global, and equitable, prioritising those in greatest need wherever they live”. 

“There is an urgent need to understand what pricing policies would be put forward by Gilead, and whether the same populations excluded today from the possibility of acquiring lower-cost generic products in the future, will also be left with unaffordable for-profit prices.”

Story updated to include UNAIDS comment.

Image Credits: Gilead.

Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.