US approves twice-yearly HIV jab in ‘breakthrough moment' for fight against Aids
Lenacapavir was developed by the US drug company Gilead, and is already sold under the brand name Sunlenca to treat HIV infections. But two clinical trials last year raised expectations that the drug could prove even more powerful as a pre-exposure prophylaxis (PrEP) tool.
In one study in South Africa and Uganda, called Purpose 1, some 5,000 sexually-active women were tracked – none of those taking lenacapavir caught HIV from their partners, compared to two per cent of those taking a daily pill. In Purpose 2, only two of 3,200 men, transgender, and non-binary people developed the disease – an efficacy of 96 per cent.
When the results were published last year, experts told The Telegraph they were 'stunning'.
'I have been undertaking research on HIV prevention in women for just over 35 years,' said Prof Salim Abdool Karim, director of the Centre for the Aids Program of Research in South Africa, which contributed to the trial. 'In all of that time, I have never seen a result as compelling as this.'
Subsequent research has suggested that the drug, named the 2024 scientific breakthrough of the year by Science journal, also has the potential to work for up to a year.
Still, even in the current twice-yearly form, it is hoped the injection will be easier to administer than an alternative jab currently sold by GSK, which must be given every two months.
Lenacapavir could also solve major issues limiting the impact of daily PrEP pills. In real world studies, efficacy drops to as low as 60 per cent because people forget to take a tablet, or are unable to refill supplies. Some people also don't want to be seen with the tablets or attend frequent doctors appointments because of stigma around HIV, Aids and homosexuality.
'This is a historic day in the decades-long fight against HIV,' said Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences. '[This drug] is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.'
Drug must be 'accessible and affordable'
The FDA is the first regulator to approve the drug. Yet the high cost of lenacapavir, combined with sweeping cuts to global health spending and doubts about the future of Medicare in the US, has raised concerns that its impact will be blunted.
Gilead has said it will sell lenacapavir under the brand name Yeztugo, for $28,218 per person per year in the US.
The company has already signed agreements with six generic drug makers to produce low-cost versions of the shot for 120 poor countries – mostly in Africa, Southeast Asia and the Caribbean – and said it plans to supply two million people in these countries at no profit until these are available.
Yet critics said two million people – while it sounds like a lot – is a drop in the ocean, given an estimated 39.9 million people are living with HIV worldwide. Researchers have estimated that you need to treat between 40 and 50 people to stop a single new infection.
Critics add that the deal does not cover middle income countries – including Brazil, Mexico, Malaysia and Algeria – and pointed to research in the Lancet suggesting it could be manufactured for as little as $25.
'UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of rollout,' said Ms Byanyima. It is beyond comprehension how Gilead can justify a price of $28,218.
'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.'
Kevin Robert Frost, chief executive of amfAR, The Foundation for AIDS Research, added: 'Having the option of a twice-annual shot, rather than relying on a daily pill, will make long-term adherence to PrEP much easier for many. But this remarkable drug will only be as effective as it is accessible and affordable.'
Meanwhile some of the major funders of HIV prevention programmes, who would contribute to funds for lenacapavir for countries worldwide, have been badly hit by aid spending cuts.
For instance in January, the Trump administration froze spending from the President's Emergency Program for AIDS Relief (PEPFAR), and while waivers later allowed treatments to resume, most of the funding for HIV prevention is still on hold. The only current exception is to prevent transmission from a pregnant woman to her child.
'It's a very difficult situation,' Andrew Hill, a pharmacology researcher at Liverpool University, told NPR. 'Because of the cuts in funding, we're going to see millions of people die from HIV in the next several years.'
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