Latest news with #HIVPrEP
Reuters
27-06-2025
- Business
- Reuters
Gilead shares rise after US top court ruling on preventative coverage
June 27 (Reuters) - Shares of Gilead (GILD.O), opens new tab rose nearly 3% after the U.S. Supreme Court on Friday preserved a key element of the Obamacare law that helps guarantee that health insurers cover preventive care at no cost to patients. At the heart of the case was whether the U.S. Preventive Services Task Force (USPSTF), which determines which preventive services insurers must cover at no cost, was unconstitutionally structured because its members are appointed without Senate confirmation. The 5th Circuit ruled in 2024 that the task force's structure violates the Constitution. On Friday, the justices in a 6-3 decision reversed the lower court's ruling. This eased fears on insurance coverage for PrEP, or pre-exposure prophylaxis, drugs approved in the U.S. to prevent HIV infection, which can cause AIDS. "This ruling is a relief in maintaining the critical role of the U. S. Preventive Services Task Force to cover preventive care services under the Affordable Care Act, including HIV PrEP," said Mitchell Warren, AIDS nonprofit AVAC's executive director in an email. The drugs are made by Gilead and by ViiV Healthcare, a joint venture of GSK (GSK.L), opens new tab, Pfizer (PFE.N), opens new tab and Shionogi (4507.T), opens new tab. Analysts had warned ahead of the verdict that any adverse decision could reduce uptake among lower-income and younger patients, weighing on Gilead's HIV prevention revenues. Gilead's HIV franchise, including its PrEP products, is a significant revenue driver. Obamacare had fueled broad insurance coverage without cost-sharing, contributing to steady prescription volumes. Gilead's HIV business, which includes prominent PrEP drug Descovy, accounted for $4.6 billion in sales in the latest reported quarter. Total revenue during the said period was $6.6 billion.
The Hill
18-06-2025
- Health
- The Hill
FDA approves 6-month HIV prevention shot
Pharmaceutical company Gilead Sciences announced Wednesday the Food and Drug Administration (FDA) has approved its six-month, twice-yearly HIV PrEP injection, which was found in trials to be more than 99.9 percent effective among participants. Gilead's product Yeztugo, a form of lenacapavir, was approved for reducing the risk of sexually acquired HIV in adults and adolescents when injected twice a year. Lenacapavir is also marketed as Sunlenca, administered orally or through injection, as a treatment for HIV/AIDS in combination with other drugs. The drug is solely manufactured by Gilead. There are currently three available HIV PrEP options: two oral pills taken daily — Truvada and Descovy — and a long-acting injection called Apretude administered every two months. '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, co-Director of the Emory Center for AIDS Research, said in a statement shared by Gilead. In a Phase 3, double-blind, randomized study, there were only two HIV infections among 2,179 participants who received Yeztugo subcutaneous injections twice a year. Lenacapavir is currently not approved for HIV prevention outside of the U.S., though it is approved for treating HIV in several countries. 'In the U.S., Gilead is working closely with insurers, healthcare systems and other payers with the goal of ensuring broad insurance coverage for Yeztugo,' the company said in a statement. 'Additionally, for eligible commercially insured individuals with commercial insurance, Gilead's Advancing Access® Co-Pay Savings Program will reduce out-of-pocket costs to as little as zero dollars.' Carl Schmid, Executive Director of the HIV+Hepatitis Policy Institute, called the approval a 'monumental advance in HIV prevention.' 'Long-acting PrEP is now not only effective for up to six months but also improves adherence and will reduce HIV infections—if people are aware of it and payers, including private insurers, cover it without cost-sharing as a preventive service,' said Shmid. 'Recent actions by the Trump administration to decimate HIV prevention jeopardize access to preventive measures such as PrEP,' he added. 'In fact, the president's budget zeroes out all CDC HIV prevention and surveillance funding, hampering our nation's ability to make people aware of and access new HIV prevention measures. Dismantling these programs means that there will be a weakened public health infrastructure and much less HIV testing, which is needed before a person can take PrEP.' The Hill has reached out to the White House for comment.
The Hill
29-04-2025
- Health
- The Hill
Trump administration proposes getting rid of crisis hotline serving LGBTQ+ youth
WASHINGTON (WDCW) — The Trump administration is planning to eliminate the 988 suicide and crisis prevention hotline, which serves members of the LGBTQ+ community. According to a leaked draft of the federal budget, the program, which launched in 2022 and is funded through the Department of Health and Human Services (HHS), could end as soon as Oct. 1 if it's approved by Congress. The Trevor Project, which offers help through 988, said the hotline has provided life-saving services to more than 1.2 million crisis contacts. DC mayor reveals part of FY26 budget, some childcare programs fully funded Suicide is one of the top causes of death among young people aged 10-25. Trevor Project CEO Jaymes Black said in a statement that ending the 988 suicide and crisis lifeline program will put the lives of LGBTQ+ youth at risk. The Human Rights Campaign (HRC) warned that the deep cuts to HHS in staffing and funding will also negatively impact programs aimed at HIV and STI prevention and access to HIV PrEP medications. 'We have seen an unconscionable amount of tax on LGBTQ+ health at all levels,' said Matthew Rose, senior public policy advocate for HRC. 'Nothing like this has ever existed in any other administration before, and we are here to say that we won't stand for it. And that our people, our lives and our communities matter and that what they're doing does nothing to advance anything they say, what they want to make happen.' Black said regardless of federal funding, the Trevor Project will remain available 24/7 for anyone in need just as they 'always have.'
Yahoo
25-04-2025
- Health
- Yahoo
Trump administration proposes getting rid of crisis hotline serving LGBTQ+ youth
WASHINGTON () — The Trump administration currently has plans to eliminate the 988 suicide and crisis prevention hotline, which specifically serves members of the LGBTQ+ community. DC mayor reveals part of FY26 budget, some childcare programs fully funded According to a leaked draft of the federal budget, the program, which launched in 2022, is funded through the Department of Health and Human Services. It could end as soon as Oct. 1 if it's approved by Trevor Project, which offers help through 988, said the hotline has provided life-saving services to more than 1.2-million crisis is one of the top causes of death among young people aged Project CEO Jaymes Black said in a statement that ending the 988 suicide and crisis lifeline program will put the lives of LGBTQ+ youth at risk. The Human Rights Campaign warned that the deep cuts to HHS in staffing and funding will also negatively impact programs aimed at HIV and STI prevention and access to HIV PrEP medications. 'We have seen an unconscionable amount of tax on LGBTQ+ health at all levels,' said Matthew Rose, senior public policy advocate for the Human Rights Campaign. 'Nothing like this has ever existed in any other administration before, and we are here to say that we won't stand for it. And that our people, our lives and our communities matter and that what they're doing does nothing to advance anything they say, what they want to make happen.' Black said regardless of federal funding, The Trevor Project will remain available 24/7 for anyone in need just as they 'always have.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Yahoo
15-04-2025
- Health
- Yahoo
Kennedy's deep HHS cuts threaten HIV/AIDS response
In drastically cutting down its public health workforce, the Trump administration is potentially undoing decades of work combatting the HIV epidemic and delaying upcoming advances. When Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced plans to reduce his department's staff by 20 percent, several divisions within the Centers for Disease Control and Prevention (CDC) were effectively eliminated, with programs focused on HIV and AIDS hit especially hard. The entire staff at the Office of Infectious Diseases & HIV Policy (OIDP) was eliminated and other divisions dedicated to HIV were severely cut down. Both the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention (NCHHSTP) as well as the Global Health Center Division of Global HIV & TB lost about a fourth of their staff. Within the CDC's division of HIV prevention, five branches were eliminated completely, including the research, surveillance and prevention communication branches. Top staffers including Jonathan Mermin, director of the NCHHSTP, and Jeanne Marrazzo, director of the National Institute of Allergy and Infectious Diseases (NIAID), were both reassigned to the Indian Health Service. The United States spends around $28 billion on its domestic response to the HIV epidemic, which amounts to roughly one percent of HHS's FY 2025 budget of $2.61 trillion. 'I don't know why HIV has been singled out,' Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, told The Hill. One of the teams that was let go oversaw guidelines for HIV PrEP. Schmid worries their absence could impact the implementation of a new investigational PrEP medication that, if approved, would only need to be administered twice a year. Along with getting rid of entire branches crucial to the HIV response, Schmid noted hundreds of research grants have been halted. Many of these grants were likely stopped due to the administration's edict to get rid of diversity, equity and inclusion (DEI) within the federal agencies. Some of the cut funding went towards HIV research focusing on trans, Black and Latino individuals, groups who are disproportionately impacted by the epidemic. 'I don't understand what 'No DEI' means. Because everything that we do is based on disparities — you know, whether you're Black, you're gay, you're trans — and also it could be geographic in certain areas. I mean, that's how you address an infectious disease. You go where the epidemic is,' said Schmid. 'If you ignore them, it's just going to get worse.' Prior to becoming HHS secretary, Kennedy publicly questioned several aspects of the HIV epidemic, including whether the virus causes AIDS. He has promoted the idea that AIDS could be caused by the recreational drug poppers, popular in the gay community. Kennedy has previously claimed that former longtime NIAID Director Anthony Fauci sabotaged effective AIDS treatments also cast doubt on the efficacy of azidothymidine (AZT), the first ever drug approved by the Food and Drug Administration to treat HIV and AIDS When left untreated, HIV can lead to AIDS, a fact acknowledged by both the CDC and the World Health Organization. Outside of conspiracy theories, Schmid sees echoes in the current administration of how the HIV epidemic was treated in the past, when government officials moralized the behavior of affected people and words like 'gay' and 'condom' couldn't be uttered in meetings. Now, terms like 'trans' and 'DEI' are being censored. The apparent kneecapping of the federal response to HIV marks a contrast to President Trump's first term, when he launched an initiative of ending the HIV epidemic by 2030. 'I think there's some new people, you know, and I don't think they're reflective of where the country is,' Schmid said of current Trump administration and its actions on the HIV epidemic. 'It doesn't seem like it's very Trumpian either.' Changes to the HIV response will also affect efforts in combatting other sexually transmitted infections (STI). 'The HIV and STI response in the United States is inextricably linked,' said David C. Harvey, executive director of the National Coalition of STD Directors. 'What happens to one program impacts the other program. What impacts these two distinct issues also impacts our larger ability to deal with infectious diseases in the U.S.' Harvey said. According to Harvey, the federal government provides the majority of STI funding for some state health departments, meaning a drastic reduction at the federal level would be 'devastating' for them, particularly for 'rural, low-income southern states.' Two branches of the CDC's STI division were also eliminated in Kennedy's culling: the STD Laboratory Reference Branch and the Disease Intervention and Response Branch. The cutting of these branches, coupled with the elimination of the OIDP and the HIV branches, means losing 'many, many years of scientific and administrative expertise,' according to Harvey. The rate of STIs in the U.S. has been on the rise over the past two decades, with a 90 percent increase since 2004. It's only in recent years that the rate of STI infections has seemed to level off. From 2022 to 2023 the number of STIs in the U.S. fell by 1.8 percent. Experts said defunding and eliminating these divisions runs counter to Kennedy's stated plans to focus on chronic illness over infectious disease. HIV, while manageable with today's medical advancements, is still currently a lifelong condition and other STIs can cause chronic illnesses. 'HIV and STIs squarely fall within the framework of chronic disease,' said Harvey. 'And we can do much more in this country to have an effective response to both prevent these diseases from ever happening and then if they do, provide universal access to testing and treatment.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
