Lenacapavir is a twice-yearly injection for HIV prevention that campaigners and funders call a major advance. Gilead has signed voluntary licensing deals, and under agreements with Indian generic manufacturers the drug will be available in 120 low- and middle-income countries at about US$40 a year. Deployment is expected from 2027, pending regulatory approval, and earlier arrangements with the Global Fund and PEPFAR had aimed to begin rollout in some supported countries by the end of 2025 and to reach 2 million people in the next three years.
The Gates Foundation will back Indian firm Hetero with upfront funding and volume guarantees and says it has invested more than US$80 million to speed market readiness and scale delivery. The Clinton Health Access Initiative, Unitaid and South Africa’s Wits RHI will give Dr. Reddy’s financial, technical and regulatory support to deliver generics from 2027 at the same price. Gilead has also signed licences with six manufacturers, including Dr. Reddy’s and Hetero, in October 2024.
Access advocates warn the deals omit many middle-income countries where HIV is rising. The International Treatment Preparedness Coalition criticised the exclusion of “dozens of countries”, and the Access to Medicine Foundation says 17 countries it tracks are excluded; those countries accounted for 19 per cent of new HIV cases in 2023. Gilead said it is prioritising registrations for 18 countries that represent 70 per cent of the HIV burden among the 120 named countries and is working with governments, regional bodies and the Pan American Health Organization to expand access in Latin America.
A study in The Lancet HIV found that scaling access to 4 per cent of the population in high-burden countries could prevent up to 20 per cent of new infections. Campaigners say funding must cover awareness campaigns, training health workers, supply, delivery and distribution. Questions remain about prices and transparency; Gilead says the price is confidential but that its pricing under partnership agreements “reflects the cost of producing and delivering lenacapavir, at no profit to the company.”
Difficult words
- voluntary licensing — agreements that let others make and sell a product
- generic manufacturer — company that makes non-brand copies of drugsgeneric manufacturers
- deployment — start or use of a product in places
- regulatory approval — official permission from authorities to use a product
- upfront funding — money provided before work or production starts
- access advocate — person or group campaigning for wider accessAccess advocates
- burden — amount of disease or problem in a place
- transparency — open information about decisions, costs and prices
Tip: hover, focus or tap highlighted words in the article to see quick definitions while you read or listen.
Discussion questions
- The article says the drug will cost about US$40 a year in many countries. Do you think this price alone will ensure wide access? Why or why not?
- Campaigners list awareness campaigns, training, supply and distribution as needed. Which of these do you think will be most difficult to organise and why?
- The article mentions some middle-income countries are excluded from the deals. How could excluding these countries affect efforts to reduce new HIV infections?
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