Latest news with #Gilead
Indian Express
38 minutes ago
- Health
- Indian Express
As US FDA approves HIV prevention drug Lenacapavir, expert says ‘India needs to take lead for its equitable, timely distribution
The United States Food and Drug Administration (FDA) on Wednesday approved Lenacapavir (LEN), the most promising HIV prevention medicine to be made so far, and according to Dr I S Gilada, president emeritus, AIDS Society of India, the real breakthrough would be when LEN becomes accessible, affordable and available to everyone in India and across the world. Lenacapavir is an antiretroviral medicine that is used for HIV prevention as a pre-exposure prophylaxis or PrEP. PrEP is a medication that can reduce the risk of HIV infection for individuals who are HIV-negative but are at risk of contracting the virus. The results of two key studies have shown that it helps prevent 99.9 per cent of all HIV transmission. 'LEN is an injectable PrEP that is to be taken twice yearly,' said Dr Glory Alexander, president of AIDS Society of India (ASI) and founder director of ASHA Foundation, Bengaluru. PrEP was first approved by the US FDA in 2012, but the Indian government's National AIDS Control Organisation is yet to roll it out. 'If we invest in HIV prevention, we not only protect people's health but also save expenses in providing lifelong HIV care, including lifelong antiretroviral therapy (ART). HIV prevention must remain at the centre-stage of our national AIDS response,' said Dr Gilada. 'Indian regulators should work with Indian generic manufacturing companies to ensure that 'made in India' generic LEN versions when available, are first rolled out in India,' Dr Gilada told The Indian Express. 'The scientific breakthrough translates into public health impact in terms of stopping the spread of HIV infection. The major impediment is the cost: LEN as PrEP to be sold as Yeztugo by Gilead is priced at US$ 28,218 per person per year. However, Gilead's wisdom by giving voluntary licenses to four Indian generic companies, gives hope that the medicine may cost less than US$ 100 – that is 0.3 per cent of the innovator's cost,' Dr Gilada explained. 'India needs to lead from the front for LEN's equitable and timely distribution at the required scale to prevent HIV transmission and help end AIDS,' said Dr Gilada, adding that only India can deliver LEN to all those in need worldwide, in terms of quality, quantity and speed. Though India meets 92 per cent of the global requirement for ART and the global community (WHO, UNAIDS, Global Fund, World Bank, etc) widely uses Indian generic pharma for their strategies like Treatment as Prevention (TasP), Test and Treat, Post-exposure Prophylaxis (PEP), PreP, etc, it is unfortunate that they are shy to acknowledge this, he said. Gilead had faced a lot of backlash from health advocates and communities last year over the astronomical pricing for LEN, pegged at over US$ 40,000 per person per year, which has now been slashed by 30 per cent. Earlier, Gilead's Hepatitis C treatment, which cost $84,000 in the US for a three-month course, was made available in India for less than $300. So the firm knew what was to be done this time, and granted voluntary licensing to six generic manufacturers, including four Indian: Dr Reddy's Laboratories, Emcure, Hetero Healthcare, and Viatris. 'All international antiretroviral therapy and prevention guidelines are conceptualised and implemented on the strength of India. Only India can meet the global demand for LEN at such low cost, just as it did for ART, at 0.3 per cent of the innovator's cost,' Dr Gilada said. Anuradha Mascarenhas is a journalist with The Indian Express and is based in Pune. A senior editor, Anuradha writes on health, research developments in the field of science and environment and takes keen interest in covering women's issues. With a career spanning over 25 years, Anuradha has also led teams and often coordinated the edition. ... Read More
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.
Time of India
11 hours ago
- Health
- Time of India
US approves Gilead's twice-yearly injection to prevent HIV
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. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like If You Eat Ginger Everyday for 1 Month This is What Happens Tips and Tricks Undo 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. Live Events 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 Truvada. Reported side effects included injection site reactions, headache, and nausea. Results 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 annually. Baumwell 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 email. Activists 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 countries. Because 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 people. However, cuts to the PEPFAR program under President Donald Trump's administration have cast uncertainty over the future of that agreement.
