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The Hindu
11 hours ago
- 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.
Mint
13 hours ago
- Health
- Mint
Gilead's bi-annual HIV prevention jab gets FDA approval: How much does it cost and how it works? All you need to know…
American biopharmaceutical major Gilead Sciences, has recieved approval from the United States' Food and Drug Administration (US FDA), for its bi-annual HIV prevention injection, to be marketed as 'Yeztugo'. Gilead shares briefly jumped 3.5 per cent — its biggest gain nearly a month, and rose 17 per cent year-on-year (YoY), till market close on June 18, Bloomberg reported. The stock outperforming a 2 per cent increase in the S&P 500 index. 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, according to an AFP report. Hailed by activists as the world's 'best tool' to fight the HIV virus, especially since no vaccine is yet available, the medicine has to be administered only twice a year and are compatible for a wide range of people, as per the report. 'This is a milestone moment in the decades-long fight against HIV. We now have a way to end the HIV epidemic,' Gilead CEO Daniel O'Day said in an emailed statement to Bloomberg. The injection demonstrated 'powerful ability' to ward off HIV infection in two major international studies last year, the BB report added. AFP reported that 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'. As many as 1.3 million people are infected with the HIV virus each year, with the highest rate in Africa. Daily pills do work, but can be forgotten by patients or also lead to stigma as the bottle can reveal people's health status. One international study published in November 2024 showed that the drug prevented all but two HIV cases among 2,180 men and transgender people — a rate 96 per cent lower than the background incidence level in that population. And in June 2025, Gilead said a trial of the shot in 2,000 women and adolescent girls in sub-Saharan Africa prevented an 'unprecedented' 100 per cent of HIV cases. It also outperformed the company's old HIV prevention daily oral pill Truvada in both studies. Yes, there are some side effects. Around 1.2 per cent of the people in the study had reactions at the injection site and stopped taking the medicine, the Bloomberg report said. Other reported side effects include headache, and nausea, according to the AFP report. Gilead said it will price Yeztugo at $28,218 per year (around ₹ 24.50 lakh), compared to the $26,400 list price of its daily HIV prevention pill, Descovy. There was no specific price given for India or other global markets. Lenacapavir's current list price for its previously approved use as a treatment for HIV is $39,000 annually, the AFP report noted. 'We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,' Gilead spokeswoman Blair Baumwell told AFP via email. The jab will compete with GSK-arm ViiV Healthcare's Apretude prevention shot, which is administered alternate months. This jab costs ₹ 15,200 for a 600mg/3ml vial, according to data on IndiaMart. Notably, Gilead already sells the same drug, lenacapavir, as a treatment for people with multidrug-resistant HIV under the brand Sunlenca — priced at ₹ 23000/box for 300 mg tablets in India, according to IndiaMart. The California-based company is looking at making the drug a 'best-seller' in rich countries, but will also be pushed toward faster roll-out in poorer and middle-income countries that face HIV crisis. And analysts surveyed by Bloomberg expect Yeztugo sales to surpass $4 billion per year by 2031. The report added that Gilead has already filed for approval in a number of countries, including Australia, Brazil, Canada, the European Union, South Africa, and the EU Medicines For All program, which helps speed the review of drugs that will be used in developing countries. In October, Gilead signed agreements with six pharma companies to produce and distribute generic versions of the drug in around 120 low-income and middle-income countries, pending regulatory approval, AFP reported. In a separate deal in December, Gilead announced partnership with the United Nations' Global Fund, the US President's Emergency Plan for AIDS Relief (PEPFAR), and others, to purchase doses for two million people. However, Donald Trump's cuts to the PEPFAR program could now impact this development. (With inputs from Bloomberg, AFP)
