Health activists have urged pharmaceutical manufacturer Gilead Sciences to lower the price of its twice-yearly injection for HIV prevention.
The activists say the injection will not live up to its potential if it remains unaffordable for the governments and people who need it most.
US-based Gilead announced on Wednesday that its long-acting jab lenacapavir had been approved by the US Food and Drug Administration (FDA), paving the way for regulators in other countries to follow suit.
Lenacapavir, branded Yetzugo, has been hailed a potential game-changer in the fight against HIV as it provides almost complete protection against infection.
But Gilead’s pricing strategy and its offer of licences to just six generic manufacturers that will supply 120 low and middle incomes has drawn fire from activists, partly because the list still excludes some badly affected countries such as Brazil.
Gilead previously said it would provide lenacapavir to the listed countries, which included SA, at no profit until generic supplies were in place, but it has not disclosed what this price would be.
“Gilead intends to maximise profit in those excluded countries through opaque, inflated ‘tiered pricing’ deals that will be unaffordable for individuals and the health systems that serve them,’’ said an international coalition of health activists that includes SA’s Health Justice Initiative (HJI).
“Lenacapavir has once-in-a-generation potential to prevent millions of new HIV infections. Accelerating global access to affordable injectable lenacapavir should be top priority for Gilead Sciences CEO Daniel O’Day,” said HJI director Fatima Hassan.
“But it will only be rolled out effectively if all low and middle-income countries are included, and there is a single affordable access price, comparable with oral pre-exposure prophylaxis,” she said.
Lencapavir will cost $28,218 for a year’s treatment in the US, according to the New York Times. However treatment with a generic version could cost $35-$46, and fall to $25 per person per year if there was guaranteed uptake of 5-million to 10-million people in the first year, according to a paper published in the Lancet earlier this week.
UNAids executive director Winnie Byanyima said Gilead’s US price for lenacapavir was “beyond comprehension”.
“This is a breakthrough moment … lenacapavir could be the tool we need to bring new infections under control — but only if it is priced affordably and made available to everyone who could benefit,” she said.
“If this game-changing medicine remains unaffordable, it will change nothing. I urge Gilead to do the right thing. Drop the price, expand production and ensure the world has a shot at ending Aids,” she said.
SA has the world’s worst HIV burden, with an estimated 7.8-million people living with the disease. There were about 173,000 new infections last year (2024), according to the Thembisa model.
More than 30 years after HIV was discovered, there is still no vaccine and a limited set of tools to prevent transmission.
While condoms and daily or monthly pills are effective, they are not suitable for everyone. Public health experts believe the twice-yearly lenacapavir may prove almost as good as a vaccine at stopping HIV in its tracks.
SA researchers released a modelling study earlier this year that found widespread use of lenacapavir would speed up SA’s efforts to eliminate HIV as a public health threat and lead to epidemic control by 2032, instead of 2042.
Even at $100 a shot it would be much more cost-effective than increasing the use of oral pre-exposure prophylaxis or another injectable called cabotegravir, they said in a paper presented at the Conference on Retroviruses and Opportunistic Infections.
Gilead is seeking regulatory approval in several countries outside the US, including SA. It submitted its dossier to the SA Health Products Regulatory Authority in March. 2025 but the regulator has yet to make a decision.
Sahpra’s review is being conducted in collaboration with the European Medicines for All initiative, which allows the European Medicines Authority to provide scientific opinion on priority medicines such as lenacapavir.
Lenacapavir can be registered in SA 90 days after it receives a green light for the EU, Sahpra spokesperson Yuven Gounden said in a written response to questions.
A Gilead spokesperson said pricing for lenacapavir had not yet been determined for any country or region outside the US.
"We’re committed to achieving broad, sustainable access to long-acting HIV [pre-exposure prophylaxis] in high-incidence, resource-limited countries — primarily low- and lower-middle-income countries.
“To that end, we are executing an access strategy, informed by global health advocates and organisations, that prioritises speed and enables the most efficient paths for the regulatory review, approval of and access to twice-yearly lenacapavir for [pre-exposure prophylaxis],” it said in a response to Business Days’ questions.
Correction: June 30 2025
This story has been corrected to reflect that Gilead included SA in its list of 120 countries that will be eligible for generic supplies of lenacapavir. A previous version of the story incorrectly stated that SA had been excluded.
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