Latest news with #lenacapavir
Associated Press
4 days ago
- Health
- Associated Press
EU regulator approves injectable HIV drug that experts say could help stop transmission
LONDON (AP) — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus' transmission. In a statement on Friday, the EU drug regulator said its evaluations of lenacapavir, sold as Yeytuo in Europe by Gilead Sciences, showed the drug is 'highly effective' and 'considered to be of major public health interest.' Once the regulator's guidance is accepted by the European Commission, the authorization is valid in all 27 EU member countries as well as Iceland, Norway and Liechtenstein. Last year, studies suggested that lenacapavir, already used to treat people with HIV, was nearly 100% effective in stopping transmission in both women and men. Winnie Byanyima, executive director of the U.N. AIDS agency, has said the drug 'could change the trajectory of the HIV epidemic' if it is made available to everyone who needs it. In June, the U.S. Food and Drug Administration authorized lenacapavir to prevent HIV. Earlier this month, the World Health Organization recommended countries offer the drug as an additional option to people at risk of the virus. Condoms help guard against HIV infection if used properly. Other medication aimed at preventing HIV include daily pills that people can take and another injectable drug called cabotegravir, which is given every two months. Lenacapavir's six-month protection makes it the longest-lasting type, an option that could attract people wary of more visits to health clinics or stigma from taking daily pills. Critics have raised concerns, however, that lenacapavir may not be made widely enough available to stop global outbreaks of HIV. Drugmaker Gilead has said it will allow cheap, generic versions to be sold in 120 poor countries with high HIV rates — mostly in Africa, Southeast Asia and the Caribbean. But it has excluded nearly all of Latin America, where rates are far lower but increasing, sparking concern the world is missing a critical opportunity to stop the disease. Last year, there were about 630,000 AIDS deaths worldwide and more than 40 million people are estimated to have HIV, according to UNAIDS. UNAIDS chief Byanyima has previously suggested the U.S. President Donald Trump make a deal with Gilead to produce and license its 'magical' prevention drug lenacapavir across the world to the millions of people who need it. ___ 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.
Yahoo
14-07-2025
- Health
- Yahoo
WHO endorses Gilead's Yeztugo for HIV prevention
The World Health Organization (WHO) is recommending the use of Gilead Sciences' newly approved injectable version of lenacapavir to fight HIV, as separate research forecasts a rise in cases in Africa amid foreign aid cuts. Announced at the 13th International AIDS Society Conference (IAS 2025) on HIV Science, in Kigali, Rwanda, the policy sees injectable lenacapavir – known under the brand name Yeztugo – added to the world's arsenal of tools endorsed by the WHO to curb HIV cases and end the epidemic. Lenacapavir was first approved in 2022 under the brand name Sunlenca for the treatment of HIV infection in adults with multi-drug resistance. An injectable version of lenacapavir given twice a year was approved by the US Food and Drug Administration (FDA) last month, licensed as a pre-exposure prophylaxis (PrEP) option for HIV prevention. The approval of Yeztugo was hailed as a historical breakthrough by HIV experts and charities. The Elton John AIDS Foundation commented that the drug 'will fundamentally bend the curve of new HIV infections'. The WHO says that the vaccine offers a highly effective, long-acting alternative to daily oral pills and other shorter-acting options. Data reported by Gilead from a Phase III trial showed that Yeztugo led to a 96% reduction in the risk of acquiring HIV. The more accessible dosing will also improve adherence and stigma, meaning more people are likely to take the drug. WHO Director-General Dr Tedros Adhanom Ghebreyesus said: 'While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk. 'The launch of WHO's new guidelines, alongside the FDA's recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.' GlobalData analysts stated that the approval of Yeztugo is a 'momentous step in improving PrEP options available for people vulnerable to contracting HIV'. However, a potential barrier to its global uptake could be cost, with the US list price for Yeztugo sitting at $28,218 per year for each patient. For comparison, GSK's Apretude – the only other injectable PrEP therapy available in the US – costs $22,000 per year, though this is given monthly. The amount of foreign aid that supports Yeztugo's rollout in Africa will therefore impact its availability. Despite scientific breakthroughs such as Yeztugo, the WHO's recommendation comes at a time of concern from public health experts about the impact of foreign aid cuts on HIV cases. Research suggests that cuts in funding made by US President Donald Trump are set to increase transmission rates in Africa. Clinical trial operations, diagnostic testing, and drug availability have already been impacted. The US President's Emergency Plan for AIDS Relief (PEPFAR), which invested significant amounts of money into HIV prevention and treatment last year, has had its funding pulled by the Trump administration. A report by UNAIDS predicts that six million new HIV infections and four million AIDS-related deaths could occur between 2025 and 2029 if US-supported HIV treatment and prevention services collapse. The WHO itself has been searching for funding recently, after Trump said the US – historically the largest contributor to the organisation – would stop sending money. Member states of the organisation agreed earlier this year to pay 20% more in membership fees to stopgap the US funding shortfall, though WHO's overall budget for 2026-2027 will be lower than that for 2024-2025. "WHO endorses Gilead's Yeztugo for HIV prevention" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Health Line
14-07-2025
- Health
- Health Line
WHO Recommends 'Breakthrough' Twice-Yearly Shot for HIV Prevention
The WHO issued a global recommendation for lenacapavir, a highly effective, twice-yearly injection to prevent HIV infection. The recommendation follows a recent FDA approval for the drug, which will be sold in the U.S. under the brand name Yeztugo. The twice-yearly shot showed near total effectiveness in clinical trials and could improve adherence rates compared to other PrEP medications. Experts are excited about using lenacapvir for HIV prevention, but remain cautious about the drug's affordability and accessibility. A drug used to treat some HIV infections can now be used to help prevent HIV, the virus that causes AIDS. The World Health Organization (WHO) issued a global recommendation for lenacapavir, a twice-yearly injection to help prevent HIV infections, particularly for higher-risk groups and in regions where HIV transmission remains high. The recommendation, issued on July 14 at the International AIDS Conference in Kigali, Rwanda, follows a recent Food and Drug Administration (FDA) approval for lenacapavir to prevent human immunodeficiency virus or HIV in adults and adolescents. Lenacapavir (Yeztugo) from Gilead Sciences has been shown to significantly reduce the risk of HIV infection in two phase 3 clinical trials that were funded by the company. The PURPOSE 1 and PURPOSE 2 trials, which were highly inclusive by design, showed that 99.9% of participants who received lenacapavir remained HIV negative. The side effects were also minimal, mostly pain or swelling at the injection site. Additionally, when compared to current preexposure prophylaxis or PrEP therapies, lenacapavir offered superior protection against the HIV virus. In 2024, Science magazine named the drug its 'Breakthrough of the Year.' PrEP treatments have been used in the United States to prevent HIV since 2012. These therapies generally involve daily oral medication (Truvada) or injections every two months (Apretude). The new biannual injection option offers an effective and appealing alternative for HIV prevention with less commitment. Yeztugo is the first and only twice-yearly option for HIV prevention available in the United States for those who may need or want PrEP. The FDA approval of this prevention therapy marks a silver lining amid uncertainty in HIV treatment and research. The Trump administration had recently announced federal cuts to funding for an HIV vaccine program and the elimination of federal support for clinical practice guidelines that advise doctors on how to diagnose and treat HIV. 'Yeztugo could be the transformative PrEP option we've been waiting for — offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,' Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and co-director of the Emory Center for AIDS Research in Atlanta, said in a news release on June 18. 'A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing,' del Rio continued. Twice-yearly shot could improve PrEP adherence rates Despite advancements in HIV treatment and prevention, in 2023, more than 100 people were diagnosed with HIV every day in the United States. A recent CDC analysis shows that up to 2.5 million U.S. adults need PrEP to prevent HIV infection. However, just over one-third of those who would benefit from the medication are prescribed it. PrEP therapies are widely available in the United States, but the medication remains underutilized due to stigma or lack of affordability, insurance, and access. Black people, African Americans, and Latin or Hispanic populations are most impacted by this disparity, as are those who reside in the Southern U.S. Experts say having a highly effective, twice-yearly PrEP option for HIV prevention could improve access for people with and without insurance and bolster adherence rates. 'Providers are excited about the approval of long-acting lenacapavir for HIV prevention since this once-every-six-month injection has been shown to have high efficacy in preventing HIV in both women and men in two large trials,' said Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco. Gandhi wasn't involved in the clinical trials. 'Data from our clinic in San Francisco, which serves low income people with or at risk of HIV, and others have shown that long-acting PrEP works well for people living with HIV who have high rates of concomitant challenges such as housing insecurity and substance use where it can be difficult to take a daily oral pill for PrEP,' Gandhi told Healthline. Gandhi further noted that higher retention rates have been observed among those on long-acting PrEP with another long-acting agent, Apretude (cabotegravir), compared to oral PrEP alone. She anticipates similar improved adherence rates for those on long-acting Yeztugo (lenacapavir), both for those who have difficulty taking an oral pill or those who might prefer the convenience of a twice-yearly injection. Twice-yearly PrEP could be a 'game-changer' Within the United States, men who have sex with men, as well as heterosexual individuals with multiple partners, are considered high risk for HIV transmission. But the need for accessible HIV prevention therapies like PrEP spans the globe. According to Gilead, regulators around the world are reviewing Yeztugo for HIV prevention. For now, the United States is the only country to approve the drug. 'It's very exciting and we have a great deal of confidence in it,' William Schaffner, MD, professor of preventive medicine and infectious diseases in the Department of Health Policy at Vanderbilt University Medical Center in Nashville, said of the drug. Schaffner wasn't involved in the clinical trials. 'It could be a game-changer,' he told Healthline. 'Short of a vaccine, this is a way to efficiently prevent HIV infection in large populations that are at high risk, not only in the developed world, but potentially in the developing world also. If we have the determination, followed by the allocation of resources to reach out to populations at high risk, we can make this available,' Schaffer noted. A promising option with obstacles ahead It's unclear when Yeztugo will become available to the general U.S. population and how much it might cost out of pocket, particularly for those without health insurance. 'I don't know how quickly the company can make this available and educate practitioners about its utility, but certainly both in the public health sector — and we'll see where the resources extend to — and in private medical circumstances, we may have to wait a little while before medical insurance programs include Yeztugo in their benefits packages,' Schaffer said. Gandhi expressed concern over the drug's high cost and whether it would be covered by large health insurance companies. A corporate spokesperson for Gilead said lenacapavir could cost around $28,218 annually per person in the United States. 'We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,' the spokesperson said by email. 'We've seen high insurance coverage for existing prevention options — for example, the vast majority of consumers have a $0 copay for Descovy for PrEP in the U.S. — and we are working to ensure broad coverage for lenacapavir.' Gandhi agreed that the estimated total cost per year is similar to the total cost of other long-acting PrEP therapies, such as Apretude (cabotegravir), but noted the medication may still be out of reach for those with low socioeconomic status who rely on federal subsidies. 'These are days of austerity in healthcare, including the concerning possibility of a $700 billion cut to Medicaid which will be determined in an upcoming Senate vote, leaving the health insurance program for low-income individuals in the U.S. severely underfunded. I urge the company to reconsider their price to improve access for Americans,' Gandhi said.
Reuters
14-07-2025
- Health
- Reuters
WHO recommends Gilead's twice-yearly injection for HIV prevention
July 14 (Reuters) - The World Health Organization on Monday recommended Gilead's (GILD.O), opens new tab lenacapavir, a twice-yearly injection, as a tool to prevent HIV infection. The recommendation, issued at the International AIDS Conference in Kigali, Rwanda, comes nearly a month after the U.S. health regulator approved the drug, giving patients new hope of interrupting virus transmission. The twice-yearly injectable offers a long-acting alternative to daily oral pills and other shorter-acting options, reshaping the response to the disease especially among those who face challenges with daily adherence, stigma, or access to health care "While an HIV vaccine remains elusive, lenacapavir is the next best thing," said Tedros Adhanom Ghebreyesus, WHO Director-General. The WHO's recommendations come at a critical moment as HIV prevention efforts stagnate with 1.3 million new HIV infections occurring in 2024 as funding challenges, stigma around the disease persist. These infections disproportionately impact populations such as sex workers, men who have sex with men, transgender people, people who inject drugs, people in prisons, and children and adolescents. WHO has also recommended a public health approach to HIV testing using HIV rapid tests that would remove a major access barrier by eliminating complex and costly procedures. Lenacapavir, part of a class of drugs known as capsid inhibitors, proved nearly 100% effective at preventing HIV in large trials last year.
Medscape
14-07-2025
- Health
- Medscape
WHO Endorses Twice-Yearly HIV Prevention Injection
The World Health Organization (WHO) is recommending a twice-yearly injection of lenacapavir for prevention of HIV, according to a press release. The injectable represents an additional option for people at risk, said Michelle Rodolph, a technical officer that the WHO, who presented the recommendations at the International AIDS Society Conference in Kigali, Rwanda. Lenacapavir was approved by the FDA for HIV PrEP in June 2025, as noted by the WHO. However, lenacapavir is not meant as a stand-alone prevention strategy, Rodolph emphasized in her presentation at the meeting. 'The WHO is very firm that lenacapavir should be offered as an additional prevention choice alongside other HIV PrEP and prevention options,' she said. This does not mean that all other prevention options need be available, but choice is important, she said. Previous research has shown that PrEP uptake is greater when individuals are offered multiple options, she added. Some considerations and research gaps related to lenacapavir remain, she added. Provider training needs to increase, as does monitoring surveillance systems, and successful introduction depends on community participation, she said. The guidelines allow for lenacapavir use in women who are pregnant or breastfeeding, Rodolph noted. The WHO also announced a new recommendation for rapid diagnostic testing. These tests may be used for HIV testing for initiation, continuation, and discontinuation of long-acting PrEP, Rodolph said. Although the recommendation is strong, the certainty of evidence is currently low, and the WHO will review emerging evidence when it becomes available and update guidance accordingly, she said. Meanwhile, the simplified testing recommendation improves access by facilitating delivery of long-acting PrEP in a variety of settings including clinics, pharmacies, and telehealth protocols, Rodolph said.
