Latest news with #Sunlenca
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.'
Gizmodo
2 days ago
- Health
- Gizmodo
FDA Approves ‘Breakthough' Drug to Prevent HIV
The Food and Drug Administration has just approved a preventative HIV drug widely regarded as a breakthrough. On Wednesday afternoon, the FDA approved Gilead Sciences' lenacapavir as a more convenient form of pre-exposure prophylaxis (PrEP). In clinical trials, the drug was shown to be highly effective at preventing HIV infection when taken just twice a year. At the same time, advocates are urging Gilead and U.S. officials to ensure the drug is widely accessible to the public. 'PrEP is one of the most indispensable tools we have for ending the HIV epidemic. 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,' said Kevin Robert Frost, CEO of amfAR, the Foundation for AIDS Research, in a statement provided to Gizmodo. 'But this remarkable drug will only be as effective as it is accessible and affordable.' The FDA first approved lenacapavir in 2022 as an antiretroviral treatment for HIV, marketed under the name Sunlenca. It was the first approved treatment of a novel drug class for HIV—drugs that directly target the capsid, or shell, of the virus. That alone has made lenacapavir a vital advance, since it can potentially treat infections that have become resistant to other drugs. But the drug's greatest potential might come from its vaccine-like ability to prevent the virus from ever gaining a foothold in the first place. A year ago, Gilead released the results of its PURPOSE 1 Phase III trial, which tested out a twice-yearly PrEP injection of lenacapavir in cisgender women. The drug outperformed daily PrEP options with a 100% prevention rate. A later trial also showed a 99.9% prevention rate among cisgender men, transgender men and women, and gender non-binary individuals. The drug's success was so impressive that Science Magazine named it as the research breakthrough of the year. Gilead is also now studying if a single yearly dose can be just as effective. As monumental as lenacapavir's arrival for PrEP may be, its cost could pose a problem—especially given Gilead's reputation. The company has long set high and often increasing list prices for its earlier PrEP drugs and it has fiercely resisted attempts by the U.S. and others to lower these prices (even today, a month's supply of Truvada can cost up to $2,000 without insurance). Gilead has also been accused of trying to delay the development of cheaper generics, though these now exist; in 2023, the company settled a class action lawsuit over these allegations. NBC News reported Wednesday that the PrEP version of lenacapavir, sold under the brand name Yeztugo, will have a list price of $14,109 per injection, or $2,352 per month. In its announcement of the FDA approval, Gilead stated that it is 'working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage.' It will also establish programs intended to reduce Yeztugo's out-of-pocket costs as low as $0 for some eligible people with or without insurance. Time will have to tell whether these assurances will be enough to make the drug widely affordable and accessible to Americans and eventually everyone else in the world. 'amfAR calls on Gilead Sciences and the U.S. government to do everything in their power to make sure as many people who want lenacapavir can get it,' Frost said.
CNBC
2 days ago
- Health
- CNBC
FDA approves Gilead's twice-yearly HIV prevention injection, offering a powerful and convenient new option
The Food and Drug Administration on Wednesday approved Gilead's twice-yearly antiviral injection for preventing HIV – a milestone that the company and some experts say could help bring the world closer to ending the decades-long epidemic caused by the virus. But the launch of the injectable drug, lenacapavir, faces a set of potential threats, including the Trump administration's proposed cuts to federal funding for HIV prevention efforts. In two groundbreaking clinical trials last year, Gilead's injection proved to be capable of virtually eliminating new HIV infections when taken every six months. Patients take it less frequently than all existing HIV prevention medications, including daily pills from Gilead and another injection from GSK received every other month. That makes lenacapavir a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O'Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women. "It's hard to overstate the importance of this for global public health," O'Day said, adding that the injection "really will bend the arc of the epidemic as we roll this out across the globe." But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications. Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year. Gilead did not immediately share how much the injection will cost under its new use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment. In a statement ahead of the approval, Gilead said the pricing of lenacapavir for HIV prevention will be in line with existing branded PrEP options. A month's supply of Truvada and Descovy, Gilead's daily pills for PreP, are both around $2,000 without insurance. One dose of GSK's Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance. The company is also committed to supplying the drug for that use globally as the virus "knows no boundaries," O'Day said. Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries. Gilead also promised to supply doses for up to 2 million people at no profit before those generic versions come to the market, O'Day said. PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men. Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu. "Unfortunately, there's still enormous amount of stigma and cultural challenges when it comes to HIV prevention," Johanna Mercier, Gilead's chief commercial officer, said in an interview. "Getting a twice-a-year injection really gives you that privacy that people have been looking for." She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and efficacy of the company's injection. In one late-stage trial, 99.9% of patients who took Gilead's injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead's daily pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who have sex with partners assigned male at birth. Another trial on cisgender women found that none of the participants who received Gilead's injection contracted an HIV infection, demonstrating 100% efficacy. In the U.S., ensuring access to underserved populations will also require broad insurance coverage. While most PrEP users are under commercial plans, the federal Medicaid program is also crucial to reaching lower-income communities. Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults with HIV, according to health policy research organization KFF. That makes Republicans' proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access. Mercier said, as of now, Gilead believes that Medicaid will continue to cover HIV services and support. "There are pretty incredible programs out there, not only Medicaid and other government programs, that really have safety nets to make sure that people who need or want access, both for HIV treatment and prevention, are set up," she said, also pointing to Gilead's programs for uninsured individuals. But PrEP4All's Johnson said the "entire foundation for HIV prevention in America is under attack at this moment." Other proposed federal funding cuts could make it harder to get Gilead's injection into the hands of physicians and patients, Johnson said. For example, the White House's proposed budget for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those run through the CDC. While some funding streams are continuing, Johnson said they are doing so "in a way that would completely destabilize the entire field of HIV prevention." He said if Congress does not push back on the proposed cuts, people currently taking PrEP "could start to slip off" and HIV infections could rise in many communities.
Yahoo
10-06-2025
- Health
- Yahoo
US FDA pauses Gilead trials testing experimental HIV pill combination
By Sneha S K (Reuters) -The U.S. Food and Drug Administration has paused Gilead Sciences' trials testing a combination of two of its experimental HIV treatments due to low levels of a type of white blood cell in some patients, the company said on Tuesday. Shares of the company, a global leader in HIV drugs, were down 2.3% at $110.35. The agency placed the trials on hold after some patients who received the combination of the drugs, GS-1720 and GS-4182, were found to have low levels of a type of white blood cell called CD4+T-cell, the company said. Gilead did not provide more information on what caused the decline in the type of white blood cell, which is a key measurement in HIV management and serves as a guide for treatment. The company said it plans to investigate and will work with regulatory authorities to resolve the issues. The paused trials included two mid-to-late studies, and three more in the early phase, the company said. The mid-to-late stage trials were testing the oral combination treatment against Biktarvy, Gilead's once-a-day pill to treat HIV. "Today's update underscores the difficulties of improving upon the profile of Gilead's once-daily Biktarvy," said BMO Capital Markets analyst Evan Seigerman. GS-4182 is an experimental pill version of the company's approved HIV drug lenacapavir, while GS-1720 is a once-weekly therapy in development for treatment of HIV. The company said the hold is not related to Gilead's application seeking FDA's approval for lenacapavir in preventing HIV. The agency is set to decide on the application by June 19. The FDA had approved lenacapavir for HIV treatment in 2022 and is sold under the brand Sunlenca. Gilead has multiple other long-acting oral and injectable HIV treatment combinations under development, and this clinical hold does not impact those combinations, the drugmaker said.
Forbes
01-05-2025
- Health
- Forbes
Why A Single Drug Could Change Everything For HIV And AIDS
CHENGDU, CHINA - DECEMBER 1: (CHINA OUT) A migrant worker wears a red ribbon during an event ... More organized by the local government to promote HIV/AIDS knowledge among migrant workers . (Photo by) A twice-yearly injection of a drug known as Sunlenca offered 100% protection against HIV among young women and girls in South Africa and Uganda, according to research published in the New England Journal of Medicine. Over 5,000 girls participated in the study, with participants receiving either the twice-yearly shot or an oral pill for HIV prevention. Of those receiving the oral pill, 2% eventually acquired HIV from infected sex partners. The study did not examine what the effect of Sunlenca would be on men. The twice-yearly shot is manufactured by U.S. drug maker Gilead and is sold as Sunlenca (Lenacapavir), but only to treat HIV, not prevent it. If found to prevent HIV infection with 100% efficacy in men too, the drug could be a huge game-changer for HIV and AIDS. Here is why. The drug operates differently from most HIV medications that usually target enzymes. Sunlenca, on the other hand, targets the HIV capsid which is a protein shell that encases the virus's genetic material. This allows the drug to interfere with multiple stages of the HIV life cycle, including but not limited to the virus's ability to assemble new viral particles, replicate and enter cells. This unique mechanism of action plays a huge role in its success to prevent the HIV virus from proliferating in a person's body. The drug is also long-acting and is injected as opposed to taken orally. This has many advantages, since taking daily oral pills can be difficult for most patients. In one study, the median rate of compliance in taking an oral pill for HIV pre-exposure prophylaxis among men was just about 64%, highlighting a major barrier in HIV prevention. Many patients on drugs for any reason struggle with the burden of taking daily pills, leading to missed doses and suboptimal treatment for their specific disease. Sunlenca's twice-yearly dose regimen eases compliance to treatment and could potentially lead to very low if not zero rates of HIV infection in the future if it were ever recommended for prevention. Sunlenca also has the potential to mitigate the stigma and psychological toll of patients that have or may be at high risk of getting HIV. Taking daily oral pills to treat or prevent HIV can act as a constant reminder of HIV for an individual, a viral infection acquired primarily through sexual contact or sharing of needles. HIV stigma refers to the negative beliefs and attitudes regarding people with HIV, which include but are not limited to judging people who are taking steps to prevent HIV or treating them differently. A twice-yearly injection can reduce this stigma, allowing people to live more normal lives without the constant reminder of their HIV status. Finally, Sunlenca can have broader implications for public health. Globally, there are approximately 40 million people living with HIV, according to Kaiser Family Foundation. Imagine a world where people can take an injection once every six months, and not worry about ever contracting the virus. This could be a reality if Sunlenca is shown to prevent HIV in a broader population, as it already has shown to be 100% effective among young girls in South Africa and Uganda. Although more thorough research and testing will be needed, Sunlenca could be a game-changer for HIV prevention. It offers a much needed hope for the millions around the world who could potentially prevent getting HIV altogether.
