American company behind HIV prevention drug criticised for excluding sub-Saharan manufacturers
6 November 2025 by Pascalinah Kabi
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South African National AIDS Council chief executive officer, Dr. Thembisile Xulu, has denounced the American biopharmaceutical company behind the HIV prevention drug lenacapavir (LEN) for shutting out sub-Saharan manufacturers — even after the region played a crucial role in the drug’s clinical trials.
Dr. Xulu’s statement drew loud applause from over 800 scientists attending the 4th International Conference on Public Health in Africa (CPHIA) in Durban, South Africa from October 22-25, 2025.
“And while we welcome lenacapivir, it is completely unacceptable that Gilead did not issue a single voluntary license to a sub-Saharan manufacturer despite our participation in their clinical trials,” Dr. Xulu said.
She added: “Sub-Saharan Africa carries the highest HIV burden and we are the largest consumer in terms of ARVs and yet we are excluded from producing the very medicines that our populations depend upon.”
Two sub-Saharan African countries — South Africa and Uganda — took part in the lenacapavir clinical trials, which involved 5,000 participants across three sites in Uganda and 25 sites in South Africa to test the efficacy of lenacapavir alongside two other drugs.
Gilead Sciences recently announced six generic companies — Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a subsidiary of Viatris) — that will manufacture and supply lenacapavir to 120 countries. All six companies are based outside sub-Saharan Africa, a region disproportionately affected by HIV.
Dr. Xulu said the region is largest consumer in terms of ARVs and “yet we are excluded from producing the very medicines that our populations depend upon.”
“That is neither sustainable nor equitable,” she said at the opening of the 4th CPHIA conference on October 22, 2025 in Durban, South Africa.
She said lenacapavir could transform HIV prevention and lead the world towards ending AIDS, only if the drug is introduced with transparency, with sustainability and with accountability.
“Lenacapavir must not undermine existing prevention tools and it must be implemented with strong community involvement. So let us remember this as we leave this conference, HIV prevention is central to universal health coverage. Local manufacturing is non-negotiable for accelerated impact and sustainability and domestic financing is an urgent requirement.
“The power to transform our health systems no longer lies in what donors decide but in what Africa chooses to build. It lies in our decision to produce our own medicines, to finance our own priorities and to strengthen the systems that serve our very own people,” Dr Xulu said.
She concluded by stressing that if LEN is to be a game changer, it won’t be because of the science of the molecule alone but because Africa chose to lead.
“Because we ensured that it was equitably accessed, sustainably financed, locally produced and delivered through people-centered systems. That is health sovereignty and that is what universal coverage demands and that is the Africa that we are building together,” she concluded.
Lesotho receives LEN funding from US
Although Gilead Sciences has not yet announced the price of its twice-yearly HIV prevention jab, the American Embassy in Maseru revealed that Lesotho has been selected to receive lenacapivir. The announcement, made on September 16, 2025, followed a meeting between Health Minister Selibe Mochoboroane and Thomas Hines, the U.S. Chargé d’Affaires.
“The U.S. government has provided $6 million to the FHI360/EpiC program to continue lifesaving work to control the HIV and TB pandemics in Lesotho. CDA Hines reaffirmed America’s commitment to supporting Lesotho’s HIV/AIDS response. Together, we are advancing the fight against TB and HIV for healthier, stronger communities,” read the statement posted on the American Embassy’s official Facebook page.
How does LEN work?
South African’s Bhekisisa Centre for Health Journalism explains how LEN works. “HIV needs to replicate to survive, but, like other viruses, it can’t survive on its own, Linda-Gail Bekker who heads up the Desmond Tutu Health Foundation, and was also the chief investigator in a trial that tested LEN on teens and young women, explained at a LEN meeting organised by South Africa’s Aids Council, Sanac, earlier this month.
To survive in humans, HIV hijacks a type of immune cell called a CD-4 cell and worms itself into its DNA, forcing the cell to make copies of the virus instead of itself, Bekker explained.
LEN is called a capsid inhibitor. A capsid is the shell around the virus’s DNA and lenacapavir messes with it in ways that make it impossible for the virus to infiltrate CD-4 cells and replicate.”
