Gilead announces plans to support generic lenacapavir for low-income countries
2 October 2024. Related: Treatment access.
Simon Collins, HIV i-Base
On 2 October 2024, Gilead issued a press release outlining plans to issue voluntary licensing agreements with six generic manufacturers to enable access to lenacapavir for 120 highest incidence and lowest-income countries. [1, 2]
The urgency of the announcement is driven by remarkable early results from two large international PrEP studies showing that 6-monthly injections provide total protection against HIV infection. [3, 4]
The plans will cover the indication to use lenacapavir both as PrEP and HIV treatment.
Gilead also commits to providing lenacapavir globally until the generic manufacturers are able to meet global demand. The six generic companies which already produce other medicines developed by Gilead are Dr. Reddy’s Laboratories Limited, Emcure, Eva Pharma, Ferozsons Laboratories Limited, Hetero and Mylan.
Eighteen countries are being prioritised for registration and access: Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia and Zimbabwe.
The full list of 120 countries are included in the 50-page license agreement, but doesn’t include key middle-income countries with high incidence. Mexico, Brazil, Argentina and Peru are excluded even though they have high HIV incidence and were included in the PURPOSE 2 study. [2]
comment
Agreements with generics companies was always going to be the only solution to achieve global access. So although this announcement is welcomed, it should have already been in place months ago when the early results from PURPOSE 1 were released.
The press release does not include an expected timeline for global access which is urgent and should also have been in place, but which for many countries still might take several years.
Lenacapavir has the potential to be so effective that it warrants exceptional status in terms of global access. On a population level, it could provide vaccine-like coverage, more rapidly and effectively than a vaccine, without the issues of vaccine efficacy.
PURPOSE 1 showed that demand for lenacapavir very effectively reached people living with HIV that were previously undiagnosed and linked them quickly to care. So access programmes for PrEP need to include sufficient support for the linked demand for early ART.
Global access could be easier and faster if lenacapavir has WHO prequalification, which could perhaps also be fast-tracked with other regulatory submissions, expected before the end of 2024.
There is also no mention of the final generic price, which will need to match generic oral PrEP. Given the potential global demand, economies of scale should make an extremely low price possible in low-income countries.
Broad access in high- and middle-income countries is less clear.
Reference
- Gilead press release. Gilead signs royalty-free voluntary licensing agreements with six generic manufacturers to increase access to lenacapavir for HIV prevention in high-incidence, resource-limited countries. (2 October 2024)
https://www.gilead.com/news/news-details/2024/gilead-signs-royalty-free-voluntary-licensing-agreements-with-six-generic-manufacturers-to-increase-access-to-lenacapavir-for-hiv-prevention-in-high-incidence-resource-limited-countries - Gilead. Generic licensing agreement.
https://www.gilead.com/-/media/gileadcorpredesign/pdf/Other/LEN-VL.pdf (PDF) - HTB. AIDS 2024: Lenacapavir as PrEP is “beyond wonderful” but PURPOSE 1 study tells us so much more. HTB (29 July 2024).
https://i-base.info/htb/48260 - HTB. Second lenacapavir PrEP study: 99.9% efficacy in early results from PURPOSE 2: ACT UP London challenge pricing. (26 September 2024).
https://i-base.info/htb/48539