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Business Standard
20-06-2025
- 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.
Time of India
20-06-2025
- 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.
Eyewitness News
20-06-2025
- Health
- Eyewitness News
US approves Gilead's twice-yearly injection to prevent HIV
WASHINGTON - 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% 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% 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 spokesperson 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.
NDTV
19-06-2025
- Health
- NDTV
Revolutionary New Drug Offers 99.9% Protection Against HIV
Despite decades of progress in HIV treatment, more than a million people are newly infected each year, and an effective vaccine remains out of reach. In a breakthrough, the US Food and Drug Administration has approved lenacapavir, a long-acting drug that offers near-complete protection against HIV with just two injections annually. While HIV prevention drugs, known as pre-exposure prophylaxis (PrEP), have existed for over a decade, their global impact has been limited due to the need for daily pill intake, a routine many struggle to follow consistently. "This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," said Daniel O'Day, Chairman and Chief Executive Officer of Gilead Sciences. "This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life's work to end HIV, and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality." In 2024, Science hailed lenacapavir as its "Breakthrough of the Year". 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 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." Pricing Raises Concerns Over Accessibility Despite the impressive results, optimism may be tempered by the drug's expected high cost. 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. While Gilead hasn't disclosed a price for Yeztugo, analysts estimate the US launch cost could reach $25,000 per year. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, though that is expected to drop when used as a preventive. 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. "To charge one thousand times more for a medicine with pandemic-ending potential would be abhorrent," added Winnie Byanyima, under-secretary-general of the United Nations. "We cannot end AIDS with medicines that are so costly." The approval also comes as President Donald Trump's administration has slashed funding for HIV treatment and prevention programs both abroad and within the United States.
The Hindu
19-06-2025
- Health
- The Hindu
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. 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 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.
