The US has approved lenacapavir as a twice-yearly injection to prevent HIV, but the game-changer drug remains out of reach for South Africans, who carry the world's highest burden of HIV. MedicalBrief writes that the drug is awaiting regulatory approval in South Africa but will be unaffordable for the vast majority of its citizens as the country is not among those to be supplied with generic versions.
Daniel O’Day, chairman and CEO of Gilead Sciences, called the approval of Yeztugo (as lenacapavir has been labelled in the US) a “milestone moment in the decades-long fight against HIV”.
“Yeztugo will help us prevent HIV on a scale never seen before. We now have a way to end the HIV epidemic once and for all,” he said.
There are concerns, though, that it will be far too expensive for low- and middle-income countries which carry the highest HIV burden, with critics slamming Gilead’s pricing strategy and its offer of licences to just six generic manufacturers that will supply 120 low and middle income countries.
The list excludes many high-burden countries, such as SA and Brazil. Gilead previously said it would provide lenacapavir to high-burden countries at no profit until generic supplies are in place, but has not disclosed what this price will be.
UNAIDS executive director Winnie Byanyima said she believes the intended market price is around $25 000 per person per year, writes Yoliswa Sobuwa for Health-e News.
Yet researchers at the University of Liverpool suggest the drug could be manufactured and rolled out at around $40 per person per year. And as the market expands, that cost could drop to as little as $25 per person annually, they said.
However, treatment with a generic version could cost $35-$46, and fall to $25 per person per year if there were guaranteed uptake of 5m to 10m people in the first year, according to a paper published in The Lancet recently.
Byanyima said Gilead’s US price for lenacapavir was “beyond comprehension”.
“This is a breakthrough moment … but only if it is priced affordably and made available to everyone who could benefit,” she said.
“If this 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 that without urgent global co-ordination on pricing and distribution, the medication’s impact may be limited to wealthier nations.
Key to curbing HIV
The rollout of long-acting prevention medicines like lenacapavir is crucial to reach the UNAIDS 2030 goals, she added.
“It’s an amazing tool, especially for girls and young women in Africa who are disproportionately affected.”
Adolescent girls and young women remain the most at risk, with the highest rates of HIV infection occurring within this group. In 2023 alone, an estimated 210 000 young women aged 15 to 24 worldwide acquired HIV, amounting to roughly 570 new infections every day in this age group.
In South Africa, nearly 1 000 adolescent girls and young women are infected with HIV each week.
“Accelerating global access to affordable injectable lenacapavir should be a top priority for Gilead,” said Health Justice Initiative director Fatima Hassan.
“The company intends to maximise profit in 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 the HJI.
“Lenacapavir has once-in-a-generation potential to prevent millions of new HIV infections,” said 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.”
SA reviews jab
While the South African Health Products Authority (SAHPRA) is still reviewing Gilead’s March application to register lenacapivir, there are other longer-acting PrEP methods approved in the country. But roll-out seems to be a challenge.
SAHPRA approved the dapivirine vaginal ring in March 2022. In December 2022, Cabotegravir (CAB-LA), the long-acting injection administered every two months, was registered. But these have yet to be rolled out.
Public health experts believe lenacapavir may prove almost as good as a vaccine at stopping HIV in its tracks.
Earlier this year, reports Business Day, SA researchers released a modelling study that found widespread use of lenacapavir would speed up the country’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 the other injectable, CAB-LA, they said in a paper presented at the Conference on Retroviruses and Opportunistic Infections.
SAHPRA’s review of the jab 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 like lenacapavir.
Lenacapavir can be registered in this country 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.
“… 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 lenacapavir” it said in a response to Business Day’s questions.
South Africa is still struggling to find additional funding to address the R7.9bn shortfall in its HIV programme since the withdrawal of Pepfar, with Health Minister Dr Aaron Motsoaledi saying in May that that while the government has been in talks with donors like the Gates Foundation and the Clinton Health Access Initiative, it hasn’t been able to secure the money.
Dr Barton Ford Haynes, director of the Duke Human Vaccine Institute, recently told CBS News that lenacapavir is a “wonderful development for the field” but said there was still a need for a vaccine.
“For HIV vaccine design and development, we’ve begun to see light at the end of the tunnel after many years of research,” Dennis Burton, an immunology professor at Scripps Research, previously told CBS News in reference to the shutting down of funding by the Trump administration.
“This is a terrible time to cut it off. We’re beginning to get close. We’re getting good results out of clinical trials.”
Burton warned that HIV vaccine research could not simply be turned back on, even if a future administration decided to change course on the funding.
He said ongoing experiments would be shuttered, and researchers assembled to study the issue would be forced to refocus their careers on other topics.
“This is a decision with consequences that will linger. This is a setback of probably a decade for HIV vaccine research,” he added.
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BusinessLIVE article – Health activists pressure Gilead to drop price of anti-HIV jab (Open access)
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