Pharmaceutical company Gilead Sciences has struck deals with six generic manufacturers to produce affordable versions of lenacapavir — a twice-yearly injectable drug that has shown near-complete effectiveness at preventing HIV infection — in 120 low- and middle-income countries. The announcement marks one of the most significant access agreements for an HIV prevention drug in years, though health advocates warn that some of the world’s hardest-hit populations have been left out.
At a glance
- Lenacapavir access: Gilead Sciences has signed licensing agreements with six manufacturers across India, Egypt, Pakistan, and the U.S. to produce and sell generic versions of the drug in 120 countries classified as high-incidence and resource-limited.
- HIV prevention trials: Clinical trials demonstrated that lenacapavir stopped HIV infection entirely among girls and women in South Africa and Uganda, and offered near-complete protection in a second trial spanning Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the U.S.
- Generic drug pricing: Researchers estimate lenacapavir could be produced profitably for as little as $40 per patient per year — compared to the $42,250 annual list price under the brand name Sunlenca in the U.S.
Why this drug matters
For decades, HIV prevention has depended heavily on daily oral medication. Adherence is a persistent challenge, particularly for populations facing stigma, poverty, or limited healthcare access.
Lenacapavir changes that equation. Two injections per year — one every six months — dramatically simplifies the prevention regimen. In the trials, the results were extraordinary. Among cisgender women in sub-Saharan Africa, zero participants who received lenacapavir acquired HIV. In the broader second trial, protection was nearly complete.
UNAIDS Executive Director Winnie Byanyima called it potentially “gamechanging — if all who would benefit can access it.” That conditional clause carries real weight.
Who’s included — and who isn’t
The six licensed manufacturers — India’s Dr. Reddy’s Laboratories, Emcure Pharmaceuticals, and Hetero Labs, alongside U.S.-based Viatris unit Mylan, Egypt’s Eva Pharma, and Pakistan’s Ferozsons Laboratories — will produce and distribute affordable versions across 120 countries, most of them lower-income nations.
Gilead has also committed to bridging supply gaps by providing its own product while generic manufacturing scales up, prioritizing 18 high-HIV-rate countries including Botswana, South Africa, and Thailand.
But the deal has drawn sharp criticism for what it excludes. Nearly all of Latin America falls outside the licensing agreement. According to UNAIDS, 41% of new HIV infections occur in upper-middle-income countries — exactly the income bracket most conspicuously absent from the deal.
Dr. Mohga Kamal-Yanni of the People’s Medicines Alliance criticized Gilead for negotiating directly with manufacturers rather than routing the agreements through the Medicines Patent Pool, the UN-backed mechanism designed to expand access to essential medicines. She said the agreements include conditions that would prevent the six licensed manufacturers from selling to excluded countries — even those that might pursue compulsory licensing under international trade law.
The access gap that remains
Compulsory licensing — a legal mechanism that allows countries to override drug patents in public health emergencies — exists as a fallback. But as Kamal-Yanni noted, it’s a route “fraught with difficulties” that can invite legal challenges from pharmaceutical companies. It’s a right, but not a simple one to exercise.
UNAIDS has also flagged that specific pricing details remain undisclosed. Advocates want full transparency on what countries will actually pay, and whether those prices will hold over time as newer manufacturers enter the market.
Gilead has said it plans to file for global regulatory approval of lenacapavir as a prevention regimen by the end of 2024 C.E. That timeline matters: approvals determine when generic manufacturers can formally enter markets and begin distribution at scale.
A breakthrough with conditions attached
Lenacapavir’s clinical results are genuinely remarkable — among the strongest ever recorded for an HIV prevention intervention. UNAIDS praised Gilead for licensing the medicine before waiting for full registration, calling that approach a model for how pharmaceutical companies should respond to global health crises.
Still, the exclusion of much of Latin America, and the absence of pricing transparency, mean this deal lands as a significant step rather than a complete solution. The World Health Organization estimates approximately 39 million people were living with HIV globally as of 2022 C.E., with 1.3 million new infections recorded that year. The countries left outside this agreement account for a substantial share of that ongoing toll.
The science has delivered something remarkable. The harder work — making sure that science reaches everyone it could protect — is still underway.
Read more
For more on this story, see: The Guardian
For more from Good News for Humankind, see:
- Alzheimer’s risk cut in half by drug in landmark prevention trial
- Renewables now make up at least 49% of global power capacity
- The Good News for Humankind archive on global health
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