Latest news with #lenacapavir
Medscape
13 hours ago
- Health
- Medscape
Injectable HIV Prevention Drug Gets FDA Nod
Individuals at risk for sexually acquired HIV have a new injectable option for preexposure prophylaxis (PrEP) with the US Food and Drug Administration's (FDA's) approval of lenacapavir, according to a press release from manufacturer, Gilead. Lenacapavir, marketed as Yeztugo, is the first twice-yearly injectable to be indicated for PrEP for adults and adolescents weighing at least 35 kg (approximately 77 lb). Lenacapavir is administered via an injection into the subcutaneous layer of fat in the abdomen. The resulting 'drug depot' may feel like a bump or nodule but resolves or shrinks before the next injection, according to the company. The approval was based on data from a pair of studies, PURPOSE 1 and PURPOSE 2. In the PURPOSE 1 study, published in The New England Journal of Medicine, lenacapavir was 100% effective in preventing HIV infection compared to background HIV incidence in cisgender women and significantly more effective than daily oral combination therapy of emtricitabine and tenofovir disoproxil fumarate (Truvada). Notably, the study included pregnant women and adolescents, and the drug was generally well tolerated. In the PURPOSE 2 study, also published in NEJM, lenacapavir was similarly effective for HIV infection prevention in a population of cisgender men and gender-diverse persons, with only two infections in the more than 2000 individuals randomized to lenacapavir. Overall, the injection was well tolerated but is contraindicated for individuals who test positive for HIV; a negative test is required before each injection, according to the company. The specifics of cost and insurance coverage for lenacapavir remain to be seen, but Gilead's Advancing Access medication assistance program will provide the drug at no cost to eligible patients, according to the press release. Lenacapavir was granted Breakthrough Therapy Designation by the FDA in October 2024 and was approved under the FDA's Priority Review process. Gilead has submitted a marketing authorization application with the European Medicines Agency and filed for regulatory approval in multiple countries worldwide including Australia, Brazil, Canada, and South Africa. The PURPOSE 1 and 2 studies were funded by Gilead.
Telegraph
a day ago
- Health
- Telegraph
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.'
Fox News
a day ago
- Health
- Fox News
FDA approves first twice-yearly injection that prevents HIV infection
The U.S. Food and Drug Administration (FDA) approved a new, twice-yearly shot — the first and only of its kind — to prevent HIV, the creator of the drug, Gilead Sciences, announced on Wednesday. Sold under the name Yeztugo, the company's injectable HIV-1 capsid inhibitor (lenacapavir) reduces the risk of sexually acquired HIV in adults and adolescents. "This is a historic day in the decades-long fight against HIV," said Daniel O'Day, chairman and CEO of California-based Gilead Sciences, in a press release. The medicine, which only needs to be administered twice a year, has shown "remarkable outcomes in clinical studies," as Gilead claims it could transform HIV prevention. The drug is given as an injectable under the skin that the body then slowly absorbs. Individuals must have a negative HIV-1 test prior to starting the treatment. In large trials last year, the drug was not only nearly 100% effective in its prevention of HIV, but proved superior to once-daily oral medication like Truvada, another drug by Gilead. The journal Science named lenacapavir its 2024 "Breakthrough of the Year." Lenacapavir uses a multi-stage approach that distinguishes it from other approved antiviral medications. "While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle," states the press release from Gilead. For more Health articles, visit "Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic," O'Day said in the press release. The most commonly reported adverse reactions during clinical trials included injection site reactions, headache and nausea, according to the company.
The Independent
a day ago
- Health
- The Independent
New preventative shot could ‘end HIV transmission'
The Food And Drug Administration has approved lenacapavir, a new twice-yearly injectable drug for HIV prevention. This new medication is the longest-lasting type of PrEP available, offering a significant advantage over daily pills or bi-monthly shots. Studies demonstrated lenacapavir's high effectiveness, with no HIV infections in participants receiving the shot in a study involving women and teen girls, and similar efficacy in gay men and gender-nonconforming people. Advocates believe the drug has the potential to end HIV transmission by expanding prevention opportunities and improving adherence, as users only need two injections per year. Despite its effectiveness, concerns remain about widespread access due to challenges in the U.S. healthcare system, including cuts to public health agencies and foreign aid for HIV initiatives.
Associated Press
a day ago
- Health
- Associated Press
The world's only twice-a-year shot to prevent HIV could stop transmission — if people can get it
WASHINGTON (AP) — The U.S. has approved the world's only twice-a-year shot to prevent HIV, the first step in an anticipated global rollout that could protect millions – although it's unclear how many in the U.S. and abroad will get access to the powerful new option. While a vaccine to prevent HIV still is needed, some experts say the shot made by Gilead Sciences — a drug called lenacapavir — could be the next best thing. It nearly eliminated new infections in two groundbreaking studies of people at high risk, better than daily preventive pills they can forget to take. 'This really has the possibility of ending HIV transmission,' said Greg Millett, public policy director at amfAR, The Foundation for AIDS Research. Condoms help guard against HIV infection if used properly but what's called PrEP — regularly using preventive medicines such as the daily pills or a different shot given every two months — is increasingly important. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more frequent doctor visits or stigma from daily pills. But upheaval in U.S. healthcare — including cuts to public health agencies and Medicaid — and slashing of American foreign aid to fight HIV are clouding the prospects. Millett said 'gaping holes in the system' in the U.S. and globally 'are going to make it difficult for us to make sure we not only get lenacapavir into people's bodies but make sure they come back' twice a year to keep up their protection. Gilead's drug already is sold to treat HIV under the brand name Sunlenca. The prevention dose will be sold under a different name, Yeztugo. It's given as two injections under the skin of the abdomen, leaving a small 'depot' of medication to slowly absorb into the body. People must test negative for HIV before getting their twice-a-year dose, Gilead warned. It only prevents HIV transmission — it doesn't block other sexually transmitted diseases. Some researchers who helped test the shot advise cold packs to counter injection-site pain. Global efforts at ending the HIV pandemic by 2030 have stalled. There still are more than 30,000 new infections in the U.S. each year and about 1.3 million worldwide. Only about 400,000 Americans already use some form of PrEP, a fraction of those estimated to benefit. A recent study found states with high use of PrEP saw a decrease in HIV infections, while rates continued rising elsewhere. About half of new infections are in women, who often need protection they can use without a partner's knowledge or consent. One rigorous study in South Africa and Uganda compared more than 5,300 sexually active young women and teen girls given twice-yearly lenacapavir or the daily pills. There were no HIV infections in those receiving the shot while about 2% in the comparison group caught HIV from infected sex partners. A second study found the twice-yearly shot nearly as effective in gay men and gender-nonconforming people in the U.S. and in several other countries hard-hit by HIV. Ian Haddock of Houston had tried PrEP off and on since 2015 but he jumped at the chance to participate in the lenacapavir study and continues with the twice-yearly shots as part of the research follow-up. 'Now I forget that I'm on PrEP because I don't have to carry around a pill bottle,' said Haddock, who leads the Normal Anomaly Initiative, a nonprofit serving Black LGBTQ+ communities. 'Men, women, gay, straight – it really just kinds of expands the opportunity for prevention,' he added. Just remembering a clinic visit every six months 'is a powerful tool versus constantly having to talk about, like, condoms, constantly making sure you're taking your pill every day.' Gilead said the U.S. list price, meaning before insurance, is $28,218 a year, which it called similar to some other PrEP options. The company said it anticipated insurance coverage but also has some financial assistance programs. Most private insurers are supposed to cover PrEP options without a co-pay although the Supreme Court is considering a case that could overturn that requirement. Congress also is considering huge cuts to Medicaid. And while community health centers still are an option, the Trump administration has largely dismantled HIV prevention work at the Centers for Disease Control and Prevention that would normally get the message to vulnerable populations who'd qualify for the shot, said Carl Schmid of the nonprofit HIV+Hepatitis Policy Institute. Schmid worries the shot won't meet its potential because 'we're basically pulling the rug out of HIV prevention and testing and outreach programs.' Gilead also has applications pending for the twice-yearly shot in other countries. Last fall, the company 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. Gilead plans to make enough shots to supply 2 million people in those countries, at no profit, until the generics are available, said company senior vice president Dr. Jared Baeten. Winnie Byanyima, executive director of UNAIDS, said in a statement the price is still too high. If it's unaffordable, she said, 'it will change nothing.' And HIV experts worry the arrangements Gilead has made to reduce costs in some countries leave out middle-income countries like some in Latin America. 'Everyone in every country who's at risk of HIV needs access to PrEP,' said Dr. Gordon Crofoot of Houston, who helped lead the study in men. 'We need to get easier access to PrEP that's highly effective like this is.' ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
