Affordability and broad distribution will determine how much lenacapavir changes HIV prevention. The injectable is a long-acting form of PrEP that prevents HIV from entering cells and replicating. Given every six months, it is the longest-acting injectable available and produced very strong results in late-stage trials: a 96% reduction in infections across diverse groups. In the PURPOSE 2 trial only two people out of more than 2,000 contracted HIV, and PURPOSE 1 reported no cisgender women became infected while on the drug.
Gilead Sciences is pursuing regulatory approval in a number of African countries and plans to begin regulatory processes by the end of 2024 in 18 low- and middle-income countries, including Botswana, Kenya, Uganda, South Africa, Nigeria, Tanzania, Zambia and Malawi. Mitchell Warren of AVAC has called for rapid scale-up and urged that lenacapavir be made available to at least one million people in low- and middle-income countries within the first year of rollout. Early modelling suggests a year’s supply would need to cost about US$40 to reach widespread uptake.
To speed access, Gilead has signed voluntary, non-exclusive, royalty-free licences with six generic manufacturers, including Dr. Reddy’s, Emcure and Mylan, to produce and sell generics in 120 resource-limited countries. The company says it will provide the product at no profit until generics can fully support demand and is working with regulators and initiatives aimed at WHO pre‑qualification to accelerate approvals.
- Remaining challenges include building a reliable supply chain.
- Programs must ensure people return for injections every six months.
- Communities need a range of prevention choices and local support.
Countries such as Zambia and Kenya are likely early adopters and will test the real-world impact of the new prevention option.
Difficult words
- affordability — how easily people can pay for something
- distribution — process of making products available widely
- injectable — medicine given by injection into the body
- long-acting — working for a long time after one doselongest-acting
- regulatory approval — official permission from authorities to sell a product
- scale-up — process of increasing program size quickly
- uptake — the number of people who start using something
- supply chain — the system that moves products to users
Tip: hover, focus or tap highlighted words in the article to see quick definitions while you read or listen.
Discussion questions
- What are the main barriers to making lenacapavir affordable and widely available in low- and middle-income countries?
- How could signing royalty-free licences with generic manufacturers affect access and price in resource-limited countries?
- Why is it important to offer a range of prevention choices and local support alongside this injectable option?
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