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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The Independent
4 hours ago
- The Independent
US approves breakthrough HIV jab – but aid cuts mean it may not get to millions in need
US medicines regulator the Food and Drug Administration (FDA) has approved a groundbreaking HIV prevention jab hailed as having the potential to quell the Aids pandemic. But the moment has been overshadowed by the spectre of aid cuts, placing in doubt whether this breakthrough injection – lenacapavir – will get to the people who need it most. Lenacapavir given in a twice-yearly injection stops HIV from replicating, protecting close to 100 per cent of people from developing the virus if they are exposed to it. This approval is one of the last crucial steps to getting the drug, branded Yeztugo, out to patients. Although the FDA's approval only applies to US patients, the World Health Organization (WHO) said it paved the way for its own recommendation of the drug and for approval in other countries. Director of WHO's Global HIV, Hepatitis and STI Programmes, Dr Meg Doherty described it as a 'regulatory milestone' adding: 'We are working with partners and national authorities to ensure lenacapavir reaches people who need it most – quickly, safely and equitably.' Researchers have raised concerns that, amid aid cuts, the jab will be too expensive to be taken up by lower-income countries. Gilead – the drugs company producing lencapavir – did not make public the cost of each dose to global funders but it announced a US price of $28,218 per year for each patient. 'If this game-changing medicine remains unaffordable, it will change nothing,' said Winnie Byanyima, executive director of the United Nations' Aids agency, UNAIDS. She called the approval of lenacapavir a 'breakthrough moment' adding the jab, '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. ' UNAIDS has seen research that lenacapavir can be produced for just $40 per person per year, falling to $25 within a year of roll out. It is beyond comprehension how Gilead can justify a price of $28,218.' Dr Andrew Hill, a pharmacology research fellow at the University of Liverpool, worked on the research which found lenacapavir could be provided for as little as $25, including a 30 per cent profit margin. 'Scientifically, it's a great moment that we have a drug which has been judged to be safe and efficacious by a leading regulatory authority in the world,'' he said. 'Public health-wise and in terms of the epidemic, it's tragic because the drug is so expensive that it's not going to get used'. It is also unlikely to be affordable in the UK, he said, despite government promises to end new cases of HIV in England by 2030. A Gilead spokesperson said, 'Yeztugo is priced in line with existing branded PrEP [pre-exposure prophylaxis] options. We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage in the US. 'We're taking unprecedented actions with urgency to plan for access to lenacapavir for PrEP globally—particularly in low- and lower-middle-income countries where the need is greatest.' Gilead signed agreements with six pharmaceutical companies in India, Pakistan, Egypt, and the US to allow them to make generic versions of the drug in order to increase supply and drive down the cost of the jab. This will take some time. Gilead also agreed to sell enough doses of the jab to protect at least two million people over three years in lower-income countries. These would be paid for by global funders led by the US President's Emergency Plan for Aids Relief (Pepfar) and the Global Fund to Fight Aids, Tuberculosis and Malaria. However, The Independent reported earlier in the month that these doses are now at risk because of US funding cuts. A significant chunk of the money to fund the doses of lenacapavir was set to come from the US-led global Aids response programme, Pepfar, as well as the Global Fund whose biggest donor was the US. This funding is now uncertain. Figures previously reported by The Independent suggest President Trump's slashing of foreign aid has derailed the projected end of the Aids pandemic and could lead to four million extra deaths by 2030. 'It does feel like this thing that could help us end the epidemic sooner is suddenly receding in the chaos,' said Prof Linda-Gail Bekker, whose trial demonstrated lenacapavir's effectiveness. The aid-funded doses are thought to cost much less than the US list price of almost $30k but still roughly five times more expensive than Dr Hill believes is necessary. And they are in an initial pilot phase, he said: 'We need to get into a different level where we're giving lenacapavir to tens of millions of people'. This is even more important as aid cuts are slashing the HIV prevention budgets of governments across Africa, he said. 'We're in this crazy position where we have a brand new highly effective vaccine-like drug and actually we will probably see the epidemic get worse over the next four years.'
The Independent
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Reuters
10 hours ago
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Insight: Trump aid cuts deal a blow to HIV prevention in Africa
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Sub-Saharan Africa had 390,000 AIDS-related deaths in 2023, or 62% of the global total, according to UNAIDS, the United Nations AIDS agency. However, progress has been made: that death toll was down by 56% from 2010, according to the World Health Organization. Now, some of those who've lost access to the preventative medication because of U.S. cutbacks are already testing positive, according to 10 patients, health officials and activists. Restrictions on PrEP have coincided with dwindling supplies of more widely used HIV prevention tools like condoms and lubricants "because of the US funding cuts", according to a UNAIDS fact sheet, opens new tab from May. The combination is creating what nine activists and three medical experts described as a major threat to prevention across the continent. "I just see this as incredibly short-sighted because we were on a winning path," said Linda-Gail Bekker, an HIV expert at the University of Cape Town. She said that many African governments did not have the resources to spend on PrEP drugs on top of treatment for HIV infections, risking a worsening of the pandemic. "It's as predictable as if you take your eye off a smouldering bushfire and the wind is blowing: a bushfire will come back." Trump has said that the United States pays disproportionately for foreign aid and he wants other countries to shoulder more of the burden, as he seeks to reduce U.S. government spending across the board. The U.S. disbursed $65 billion in foreign assistance last year, nearly half of it via USAID, according to government data, opens new tab. "It's a question of who has primary responsibility for the health needs of citizens of other countries, and it's their own governments," said Max Primorac, a former senior USAID official who is now senior research fellow at The Heritage Foundation's Margaret Thatcher Center for Freedom. "We all know, and this is a bipartisan issue, that aid dependency doesn't help these people - that the best solution is for these countries to be able to take over the responsibility of these programs." UNAIDS says the permanent discontinuation of PEPFAR-supported prevention and treatment programs could lead to an additional 2,300 new HIV cases globally per day. There were 3,500 new cases per day in 2023. Reuters spoke to 23 health workers, PrEP users and activists, nearly all of whom said that the increase in HIV infections since the funding cuts was impossible to quantify because many organisations working with vulnerable populations have been defunded. A State Department waiver issued on February 1 allowed some PEPFAR activities to restart, but only covered HIV prevention for mother-to-child transmission. That means PEPFAR-financed PrEP is no longer available for gay and bisexual men, sex workers and injecting drug users who are especially exposed to the virus. Many African governments had specifically targeted these groups in their PrEP programs. A spokesperson for the State Department, which oversees USAID and the PEPFAR program, told Reuters it "continues to support lifesaving HIV testing, care and treatment, and prevention of mother to child transmission services approved by the Secretary of State." "All other PEPFAR-funded services are being reviewed for assessment of programmatic efficiencies and consistency with United States foreign policy," the spokesperson said. The spokesperson did not directly respond to a question about why the waiver had excluded vulnerable groups from PrEP distribution. In East and Southern Africa, the sub-region that accounts for more than half of all people living with HIV, the U.S. had been funding nearly 45% of HIV prevention programming, UNAIDS said in March, opens new tab. Some countries like Malawi, Zimbabwe and Mozambique were almost entirely dependent on PEPFAR for their HIV prevention programs, the agency said. In some wealthier nations, like South Africa and Kenya, PEPFAR represented less than 25% of spending on HIV prevention. Russell Vought, the director of the U.S. Office of Management and Budget, told a Congressional committee on June 4 that, due to high U.S. debt levels, Africa needed to shoulder more of the burden in fighting AIDS. Asked specifically about restrictions on HIV prevention programs, Vought said: "We believe that many of these nonprofits are not geared toward the viewpoints of the administration." His office did not respond to a request for further details. Reuters spoke to four PrEP users in Nigeria, all gay or bisexual men, who have tested positive for HIV since January when they stopped being able to obtain more pills, after practicing unsafe sex. Hearty Empowerment and Rights (HER) Initiative, a community-based organisation in southeastern Nigeria, worked with other groups that provide HIV/AIDS services to confirm the men's diagnosis and help secure treatment for them, said executive director Festus Alex Chinaza. In Asaba, the capital of Nigeria's Delta state, Echezona, a 30-year-old gay man who took PrEP pills daily for more than three years, is struggling to come to terms with his HIV-positive test result, which he received in early May. He regrets that he had unprotected sex. "I just pray and wish that Trump actually changes his policy and everything comes back to normal so that the spread and transmission of the virus would be reduced," said Echezona, who asked to be identified only by his first name for fear of stigma. Like the other three men, he described being told by staff at community-based clinics that PrEP was only available to pregnant and lactating women, in line with the Trump administration guidelines. Nigeria has an adult HIV prevalence rate of 1.3% and an estimated 2 million people living with HIV, the fourth-highest total globally, according to UNAIDS. But for so-called key populations, the rates are much higher: 25% for men who have sex with men, according to a survey completed in 2021. The Nigerian health ministry did not respond to a request for comment on the effects of the Trump administration's cuts to HIV prevention services. South Africa – which has an estimated 7.7 million people living with HIV, according to UNAIDS, the highest number in the world - pays for its own PrEP pills. But some clinics where so-called key populations obtained them relied on PEPFAR grants and have been forced to close in recent months. PrEP is also available for free at public health centers, but gay men and sex workers often avoid such facilities, fearing discrimination and harassment, nine activists said. Francois Venter, executive director of the Ezintsha medical research center at the University of the Witwatersrand in Johannesburg, said PrEP distribution from public sector clinics in the city had shown almost no increase since the Trump cuts. Foster Mohale, spokesperson for South Africa's health ministry, said the ministry was "not aware" of reports that key populations were avoiding health facilities due to stigma. "We have sensitized health officials across the country to create (a) conducive environment for all healthcare seekers/clients to access the service without feeling judged or discriminated against," he said.
