Two Indian manufacturers will be able to mass-produce cheap generic versions of the HIV ‘miracle’ drug, lenacapavir, which almost eliminates HIV transmission via an injection given twice a year – thanks to support from donors.

The Gates Foundation will support Hetero Labs, while Unitaid, the Clinton Health Access Initiative (CHAI), and Wits RHI will support Dr Reddy’s Laboratories. This will reduce the annual price per patient for the two injections to $40, according to simultaneous announcements in New York on Wednesday.

Gates is offering Hetero “upfront funding and volume guarantees”, and Unitaid-CHAI-Wits RHI will provide Dr Reddy’s with “financial, technical, and regulatory support to deliver affordable, quality-assured generic versions of lenacapavir to low- and middle-income countries (LMICs) by 2027, following regulatory approval.”

In clinical trials, lenacapvir eliminated 99% of HIV transmission, making it the closest product to an HIV vaccine.

One study shows that scaling up access to lenacapavir to just 4% of the population in high-burden countries could prevent up to 20% of new infections, according to the Gates Foundation.

It has made more than $80 million available in “catalytic investments” to accelerate market readiness, scale delivery, and shorten the timeline for generic entry of lenacapavir.

End HIV

“Scientific advances like lenacapavir can help us end the HIV epidemic—if they are made accessible to people who can benefit from them the most,” said Trevor Mundel, president of global health at the Gates Foundation. “We are committed to ensuring that those at highest risk, who can least afford it, aren’t left behind.”

“Securing a US$40 price for the twice-yearly lenacapavir injection for PrEP is a historic breakthrough that proves the most advanced tools can be made affordable from the very start,” said Unitaid’s executive director, Dr Philippe Duneton.

In 2024, Gilead Sciences granted royalty-free licenses for lenacapavir production to six generic manufacturers for 120 low- and middle-income countries. Following regulatory approvals, generic lenacapavir will flow through national HIV programs and public procurement channels such as the Global Fund.

On 4 September, the US government announced that lenacapavir’s US manufacturer, Gilead, had made the drug available to the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund at cost.

PEPFAR plans a “market-shaping initiative” to get the drug to some two million people in countries with high burdens of HIV, according to the US announcement.

PEPFAR will focus on using lenacapavir to prevent mother-to-child HIV transmission.

Still ‘far away’

“The deals announced today on generics are a major step forward in ending the HIV epidemic,” said Kate Hampton, CEO of the Children’s Investment Fund Foundation (CIFF), which is also supporting the rollout of lenacapavir via the Global Fund. 

“They build on full value-chain investments by CIFF and others to foster a competitive market so that access to lenacapavir is affordable and reliable for all those who need it.”

“This is a watershed moment. A price of $40 per person per year is a leap forward that will help to unlock the revolutionary potential of long-acting HIV medicines,” said Winnie Byanyima, executive director of UNAIDS.

Describing lenacapavir as “revolutionary”, UNAIDS pointed out that its current annual price in the US is $28,000 per person.

UNAIDS estimates that 1.3 million people were infected with HIV in last year.

Beatriz Grinsztejn, president of the International AIDS Society, welcomed lenacapavir generics being made affordable, but said “availability in 2027 still feels far away.”

“With the HIV response in a funding crisis, countries are already making difficult trade-offs. To realize the full potential of this innovation, [pre-exposure prophylaxis] options like lenacapavir must reach the most vulnerable people, which requires urgent, additional investment to avoid delays or denied access.”

Meanwhile, a global HIV activist coalition noted that the $40 price will be “restricted to the 115 LMICs and five territories covered by Gilead’s voluntary license” announced  earlier this year.

They called for global access tongenerics, particularly as “over a quarter of new HIV acquisitions occur in the 26 countries and territories that are excluded by Gilead from its license, including Argentina, Brazil, Mexico”.

Image Credits: Gilead, Gilead.