Thanks to generous donor support, two Indian manufacturers will be able to mass produce cheap ($40) generic versions of the HIV “miracle” drug lenacapavir (Yeztugo), which almost eliminates HIV transmission via a twice-yearly injection.
Kerry Cullinan writes in Health Policy Watch that 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 only $40, as opposed to the $28 000 price tag in the United States.
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”.
The Gates Foundation has allocated more than $80m in “catalytic investments” to accelerate market readiness, scale delivery, and shorten the timeline for generic entry of lenacapavir.
Critical
“Generic manufacture of lenacapavir is essential to ensure this breakthrough HIV prevention option is not limited to a privileged few,” Professor Saiqa Mullick, director of Implementation Science at Wits RHI, told Reuters, adding that the generic version of the drug, with its low price point, could be a preferred choice by millions affected in low-income countries.
“Scientific advances like this 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, while Unitaid’s executive director, Dr Philippe Duneton, said that securing a $40 price was “a historic breakthrough that proves the most advanced tools can be made affordable from the very start”.
In 2024, Gilead Sciences granted royalty-free licenses for lenacapavir production to six generic manufacturers for 120 low- and middle-income countries.
After regulatory approvals, generic lenacapavir will flow through national HIV programmes and public procurement channels like the Global Fund.
Early last month, the US Government had announced 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 2m people in countries with high burdens of HIV, according to the US announcement, and would focus on using lenacapavir to prevent mother-to-child HIV transmission.
“The price of $40 per person per year is a leap forward that will help to unlock the revolutionary potential of long-acting HIV medicines,” Winnie Byanyima, executive director of UNAids, told Health Policy Watch.
Major step
“The deals announced 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.”
Describing lenacapavir as “revolutionary”, UNAids said that its current annual price in the US is $28 000 per person.
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 realise 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.”
“The availability of generics at an affordable price… will magnify the impact of this game-changing innovation,” Peter Sands, chief executive of the Global Fund, told Reuters.
According to CHAI, the $40 price point puts the long-acting injectable on par with daily oral PrEP meds, and is “a new model for how innovation reaches those who need it the most”, CEO Buddy Shah told FiercePharma.
“With the signing of the new partnership deals, the generic marketplace for Yeztugo is taking shape, and the multiple suppliers will create necessary competition to keep prices low and offer procurement flexibility,” CHAI noted.
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 to generics, particularly as “more than 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”.
See more from MedicalBrief archives:
Lenacapavir to be rolled out via Pepfar to selected countries
New injectable HIV drug could be much cheaper, study shows
Gilead inks deal for generic HIV drug supply to low-income nations