Latest news with #Yeztugo
The Independent
4 hours ago
- Health
- 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.'
Indian Express
7 hours ago
- Health
- Indian Express
US FDA approves HIV prevention drug: Why is this a breakthrough?
A twice-yearly injectable drug for the prevention of HIV infection has been approved by the United States' Food and Drug Administration. With better compliance expected — instead of daily pills on a shot every two months that people have to take at the moment — it is one of the most anticipated developments in the field of HIV prevention. The Lenacapavir injection — sold as Yeztugo by pharmaceutical giant Gilead — was approved based on the results of two Phase 3 trials that showed 99.9% of individuals remained HIV negative with the two shots taken annually. 'FDA approval … paves the way for WHO prequalification, which can accelerate national regulatory approvals … and procurement by donor agencies like the Global Fund… Lenacapavir's discreet, long-acting formulation may help overcome key barriers such as daily pill burden, frequent clinic visits and stigma associated with HIV prevention,' the World Health Organization (WHO) said. Lenacapavir is an anti-retroviral medication that can be used to treat as well as prevent HIV. As Sunlenca, it is used in combination with other antiretroviral drugs for the treatment of people who have been on pills for a very long time and are resistant to multiple drugs. As Yestugo, it is a pre-exposure prophylaxis (PrEP) to prevent the infection. The drug works by binding with the HIV capsid — a protein shell that protects the virus' genetic material. It then disrupts crucial steps needed for the virus to replicate and infect new cells. PrEP or pre-exposure prophylaxis is a drug or injectable meant to prevent HIV infection in people at a higher risk of contracting the disease. These medicines can reduce the risk of acquiring HIV infection through sexual activity by 99% and through injection drug use by 74%. At present, there are several types of PrEP available — pills such as Truvada or Descovy, Dapivirine vaginal ring and the injectable Cabotegravir that has to be taken every two months. It is important to be tested for HIV before taking PrEP. While these medicines are also used in the treatment of HIV, they are prescribed in combination with other antiretrovirals. Given alone to a patient with HIV, they might develop resistance to the drugs. PrEP is usually recommended for people living with an HIV positive partner, those who frequently change partners, those who have sex with people with unknown HIV status, those who work in the sex industry, and those who use injectable drugs. Medicines for post exposure prophylaxis are also available to be used as an emergency measure in cases such as inadvertent exposure in a hospital setting, after condom failure, or during sexual assault. While generic versions of the PrEP pills are approved in India — Cabotegravir injection is also available through a sub-licensing contract — they are not widely used. This is mainly owing to the cost of the medicines and the fact that they are not yet part of the country's national programme, which already provides life-long treatment to all who have been diagnosed with HIV. The new injectable will cost USD 28,218 annually, remaining out of reach for many. Even in the US, usage remains low. Only 36% of the 1.2 million people who would have benefited from the medicine were prescribed it. Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
Economic Times
10 hours ago
- Health
- Economic Times
US approves Gilead's twice-yearly injection to prevent HIV
AP This photo provided by Gilead Sciences shows packaging for the company's HIV prevention medication, Yeztugo, (lenacapvir) at a manufacturing facility in La Verne, Calif., in June 2025. The US Food and Drug Administration on Wednesday approved Gilead Sciences' twice-yearly injection to prevent HIV -- a move the company hailed as a major breakthrough in the fight against the sexually transmitted virus. Drugs to prevent HIV transmission, known as pre-exposure prophylaxis or PrEP, have existed for more than a decade. But because they typically require taking a daily pill, they have yet to make a significant dent in global infections. "This is a historic day in the decades-long fight against HIV," Gilead chairman and chief executive Daniel O'Day said in a statement. Lenacapavir, marketed under the brand name Yeztugo, has been shown to reduce the risk of HIV transmission by more than 99.9 percent in adults and adolescents -- making it functionally akin to a powerful vaccine. The company conducted two large clinical trials. The first, involving more than 2,000 women in sub-Saharan Africa, resulted in a 100 percent reduction in infections and demonstrated superiority over the daily oral pill Truvada. In the second trial, involving over 2,000 men and gender-diverse individuals, only two infections were recorded - a 99.9 percent prevention rate, again surpassing side effects included injection site reactions, headache, and from both trials were published in The New England Journal of Medicine, and the journal Science named lenacapavir its 2024 "Breakthrough of the Year."- Price concerns dampen hope -Despite the impressive results, optimism may be tempered by the drug's cost -- a list price of $28,218 per year in the United States, Gilead spokeswoman Blair Baumwell told AFP in an email Wednesday. An earlier long-acting HIV prevention shot -- cabotegravir, which is injected every two months and was approved by the FDA in 2021 -- costs tens of thousands of dollars per year and has yet to make a major global impact. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 said the $28,000-plus per year cost for Lenacapavir as a preventive drug is "in line with" those of existing PrEP products and that the company inspects insurers to cover it."We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage," she said in the are urging Gilead to drastically cut the price to help end the HIV pandemic."Even high-income countries will not be able to afford widescale use of lenacapavir at prices above US $20,000 per year," said Andrew Hill of Liverpool University, who led a team of chemists and scientists that found it could be mass-produced and sold for as little as $25 per person per year."I congratulate Gilead and US partners for advancing this important innovation," added Winnie Byanyima, under-secretary-general of the United Nations. "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."In October, Gilead signed agreements with six pharmaceutical companies to produce and distribute generic versions of the drug, pending regulatory approval, in 120 low- and middle-income it will take time for those countries to begin production, the company also announced a separate deal in December with the Global Fund -- an international partnership established by the United Nations, alongside the US President's Emergency Plan for AIDS Relief (PEPFAR) and others -- to purchase doses for two million cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
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Business Standard
11 hours ago
- Health
- Business Standard
USFDA approves first HIV prevention shot needing only two doses a year
Even after decades of medical progress, HIV continues to infect thousands globally each day, according to estimates by the World Health Organization. In a major breakthrough, the US Food and Drug Administration (FDA) on Thursday approved lenacapavir, a long-acting injectable drug that offers near-complete protection against HIV with just two doses a year. Lenacapavir, developed by Gilead Sciences and marketed under the brand name Yeztugo, is the world's first twice-yearly HIV prevention shot. It could transform pre-exposure prophylaxis (PrEP) options, particularly for those who struggle with daily medication adherence due to stigma, access issues, or lifestyle factors. How does lenacapavir work? Lenacapavir is a capsid inhibitor, a class of drugs that blocks the protein shell (capsid) the HIV virus needs to replicate. Unlike oral PrEP pills that must be taken daily, lenacapavir is administered as an injection once every six months, providing a discreet and highly effective method of prevention. How effective is lenacapavir against HIV? In two large-scale clinical trials conducted by Gilead: The first trial involved over 2,000 women in sub-Saharan Africa and showed a 100 per cent reduction in HIV infections, outperforming the daily oral PrEP pill Truvada. The second trial, involving over 2,000 men and gender-diverse individuals, reported only two infections, yielding a 99.9 per cent prevention rate. 'This medicine only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention,' said Daniel O'Day, Chairman and CEO of Gilead Sciences. 'With the FDA approval of Yeztugo, we are one step closer to ending HIV.' Is lenacapavir safe? Clinical trials report that lenacapavir is well tolerated, with mild injection site reactions being the most common side effect. No serious safety concerns have emerged, making it a viable long-term option for prevention. Who stands to benefit the most? The twice-yearly dosing offers particular promise for: Young women LGBTQ+ individuals People in remote or underserved regions Public health experts say it will improve adherence and reduce infection rates in communities often left behind by daily-pill-based prevention strategies. When will lenacapavir be available outside the US? While the FDA has cleared the drug, approvals in other countries are still pending. Applications are under review in Europe, Australia, Canada, South Africa, Brazil, and Latin America. The World Health Organization is expected to release global guidance on July 14 during the International AIDS Conference in Kigali. How much will Yeztugo cost? Gilead has yet to announce the price of Yeztugo. However, analysts estimate that the US launch could cost up to $25,000 per year. Currently, lenacapavir is priced at $39,000 annually for HIV treatment use, though prices are expected to fall for prevention. Advocacy groups such as UNAIDS and Unitaid are calling for significant price reductions in low- and middle-income countries. Generic manufacturing is being explored, with estimates suggesting a potential price of $25–$46 per year if Gilead grants licences. What's the HIV situation in India? According to the National AIDS Control Organisation (NACO), an estimated 2.4 million people were living with HIV in India in 2021. That year, 41,970 AIDS-related deaths were recorded, underscoring the ongoing public health challenge.
Business Insider
11 hours ago
- Business
- Business Insider
Oppenheimer sees limited near-term impact from Gilead HIV approval
Oppenheimer says that while the firm generally agrees with consensus that Yeztugo 'has multi-blockbuster potential,' its model assumes a slow ramp that initially cannibalizes Descvoy's market share. The injectable Apretude has had a sluggish launch, but Yeztugo is different in requiring only two clinic visits a year, the analyst tells investors in a research note. Opco believes a negative Supreme Court decision in Kennedy versus Braidwood 'would most certainly create near-term headwinds.' Given the current political environment, adoption into more commercially mainstream markets will be needed to realize Yeztugo's full potential, contends the firm. It reiterates an Outperform rating on Gilead (GILD) with a $125 price target Confident Investing Starts Here:
