South African companies were excluded from Gilead Science’s voluntary licensing for the anti-HIV drug lenacapavir because those that were evaluated in 2024 did not satisfy the technical specifications for the production of sterile injectables at that time, reports AP.
According to Wendy Cupido, country manager for Gilead, the company was, however, still prepared to look at further voluntary licensing if a South African manufacturer could develop the required capabilities and meet quality standards in the future.
This followed a warning by Health Minister Aaron Motsoaledi that although the revolutionary twice-annual jab was a “ground-breaking” tool to fight the disease, the initial donated supply would be limited to only about half a million people in the country.
This comes just weeks after the United States announced plans to buy 2m doses of the drug for low-income countries.
The first supply in South Africa will kick off in April 2026, funded by a $29.2m Global Fund grant, with an additional $5m allocated by the Networking HIV and Aids Community of Southern Africa (NACOSA).
Addressing a national healthcare round-table dialogue in Johannesburg last week, Motsoaledi said the Global Fund’s catalytic commitment would deliver around 456 000 lenacapavir initiations over two years, translating into 912 000 doses.
“We plan to roll out it out initially in about 23 high-incident districts across six provinces, targeting around 360 high-performing public clinics within these areas for phase one implementation,” he said.
“About half a million people will be able to begin using lenacapavir, thanks to this support, but demand is likely to outstrip supply at first,” he added, highlighting that research data suggested that prioritising vulnerable populations in high-burden districts first would result in the highest impact in preventing new infections.
Although Motsoaledi expressed gratitude that Gilead Sciences had lowered the price from the $28 000 initially touted to $40 per person annually, he said that South Africa aimed to fund its programme independently, with long-term funding depending on lenacapavir’s integration into local systems, like the Essential Medicines List.
In July, the WHO had recommended the six-month HIV prevention jab – already approved in the US and Europe – as an additional prevention choice as part of combination approaches.
Gilead is expediting registration in 18 high-incidence countries, including South Africa, to deliver lenacapavir until generic versions become available in 2027.
Early in October, Gilead said it had executed voluntary, non-exclusive, royalty-free licence contracts with six pharmaceutical companies in Egypt, Pakistan, and India to produce and market generic lenacapavir.
However, despite participating in the clinical trials for the drug in recent years, South African companies were excluded from Gilead’s voluntary licensing, which has infuriated civil society.
“This is not the principle of ubuntu,” said Sheila Mbele-Khama, in reference to the philosophy that values principles like human dignity and fairness.
Mbele-Khama, speaking on behalf of the South African National Aids Council (SANAC), claimed that one out of every four new HIV infections took place in the 26 nations to which Gilead didn’t give licences.
“You can’t come into the house to ask us to allow you to learn and then you run away. . . and you no longer include us,” she added.
Fresh option
Welcoming the more than $34m in investment into the roll-out, UNAIDS South Africa country director Eva Kiwango said at a time when foreign assistance funding cuts could lead to an additional 6m HIV infections globally by 2029, long-acting injectable medicines were a “fresh option for all people at risk”.
“It is not a cure or a vaccine, but it could be a game-changer if made accessible to all who could benefit,” said Kiwango.
“For many people, lenacapavir expands choice, strengthens agency, and reduces barriers linked to stigma, disclosure, or daily adherence.”
See more from MedicalBrief archives:
Concerns grow over lenacapavir price transparency
Lenacapavir to be rolled out via Pepfar to selected countries
Donors enable deal for $40 generic anti-HIV ‘miracle’ drug
Gilead inks deal for generic HIV drug supply to low-income nations