Latest news with #MitchellWarren
UPI
12 hours ago
- Health
- UPI
FDA approves long-lasting HIV-prevention drug
1 of 2 | A man photographs a portion of the AIDS quilt during an HIV/AIDS rally on the National Mall in Washington, D.C., in 2021. The Food and Drug Administration has said that it has approved a new drug that could prevent HIV infections with just two shots every year. File Photo by Kevin Dietsch/UPI | License Photo June 18 (UPI) -- The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and possibly eradicate the disease. The drug's scientific name is lenacapavir and it will be marketed as Yeztugo, which requires one injection every six months to maintain its effectiveness in preventing HIV infections. Other drugs exist that also prevent HIV, but they require daily dosages in pill form and have not significantly affected the disease on a global level. "We're on the precipice of now being able to deliver the greatest prevention option we've had in 44 years of this epidemic," AVAC executive director Mitchell Warren told the New York Times. AVAC is an anti-HIV organization. He said recent funding cuts by the Trump administration will make it hard to distribute the drug globally. "It's as if that opportunity is being snatched from out of our hands by the policies of the last five months," Warren said. Gilead Sciences is producing the drug, which is the second long-lasting HIV prevention drug available. The other option is cabotegravir, which is sold under the brand name Apretude and requires an injection every two months. About 21,000 Americans use Apretude, while about 500,000 use daily oral medications to prevent HIV. Clinical trials showed most participants who received two shots of lenacapavir every year had nearly full protection against HIV. More than 39,000 people in the United States contracted HIV in 2023, which carries an estimated lifetime treatment cost of $1.1 million per patient, Gilead Chairman and Chief Executive Officer Daniel O'Day told the New York Times. Lenacapavir already is being prescribed to treat people with HIV infections that resist other medications and at an annual cost of $42,000 per patient, but most patients don't pay the full cost. Health insurance coverage and patient-assistance programs would cover the cost for most people using lenacapavir, according to Gilead. The cost for oral pills taken daily is just $1 per pill, while Apretude carries an annual cost of about $24,000. Proposed funding reductions for Medicaid and the President's Emergency Program for AIDs Relief, commonly called PEPFAR, might greatly reduce access to the drug, according to advocacy groups. The PrEP oral treatment still would be available, but it does not work for many people, Health Gap Executive Director Asia Russell told the New York Times.
Yahoo
15 hours ago
- Health
- Yahoo
FDA approves powerful HIV drug that nearly eliminated spread in clinical trials
The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported Wednesday. In clinical trials, the drug nearly eliminated HIV's spread among people given an injection every six months. Called Yeztugo, the highly effective drug has inspired feverish anticipation among advocates for HIV prevention. The hope is the medication could accelerate the stubbornly slow decline of HIV transmission in the United States. 'This is the single best opportunity in 44 years of HIV prevention,' said Mitchell Warren, executive director of the HIV advocacy nonprofit group AVAC. Yeztugo (generic name lenacapavir), which is given by health care workers in clinics, is significantly more effective than the existing oral HIV-prevention drugs, experts said, because it appears to address the challenges of sticking to a daily pill regimen for people who are at high risk of HIV. Gilead's chairman and CEO, Daniel O'Day, suggested in a statement Wednesday that the drug could 'end the HIV epidemic once and for all.' It was approved after astounding results in Gilead's large clinical trials of the drug. The trials randomly assigned people at risk of HIV to receive either lenacapavir injections every six months or daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP. Among gay and bisexual men and transgender people, the Yeztugo group had an 89% lower HIV rate than a group taking Truvada and a 96% lower rate than Gilead estimated would have been expected absent any PrEP. In a similar trial among cisgender women in sub-Saharan Africa, no one who received Yeztugo contracted HIV. The shot is the first in a new class of antiretrovirals which block HIV from infecting and making new copies of itself inside the immune cells it targets. Lenacapavir was first approved in 2022, under the brand name Sunleca, for use with other medications to treat highly drug resistant strains of the virus. All forms of PrEP work in the same way: If enough of the drug is present in the body when a person is exposed to HIV, it's highly effective at preventing the virus from taking hold and establishing a lifelong infection. Lenacapavir is so long-acting, it only needs to be injected twice a year. However, Yeztugo's use as PrEP against HIV emerges into a political climate that experts warn could derail progress against the virus' spread. The Trump administration's recent sweeping cancellations of research grants and its severe cuts to the Centers for Disease Control and Prevention's staffing have dramatically affected the HIV-prevention field in particular. HIV experts are concerned that Yeztugo's full potential might remain unrealized. Priced at $14,109 per injection, or $2,352 per month, Yeztugo's cost could be another hurdle. Health insurers, at least in the near term, might decline to cover the shots in favor of other forms of PrEP, including the cheaper generic version of Truvada pills, which cost as little as $30 per month. Or insurers might impose higher copays for lenacapavir, said Elizabeth Kaplan, director of health care access at Harvard Law School's Health Law and Policy Clinic. A pending Supreme Court decision concerning a pillar of the Affordable Care Act could also be a barrier to insurance coverage for medications that prevent HIV. The ACA, or Obamacare, mandates no-cost coverage for certain preventive interventions like PrEP. A Gilead spokesperson said that within two days from Yeztugo's approval, people should be able to start asking health care providers for the drug. However, putting aside the question of whether insurance will cover the drug, it could take up to two months for people to actually receive their first injection. Older forms of PrEP have had mixed success. Truvada, also made by Gilead, was the first approved PrEP drug in 2012, followed by a similar oral medication from the company, Descovy, in 2019. They have steadily gained popularity among gay and bisexual men, who, according to the CDC, account for 7 in 10 new HIV cases and comprise the overwhelming share of PrEP users. However, considering how much higher the HIV rate is among Black and Latino gay men compared with their white peers, PrEP use among men of color has remained disproportionately low. Experts believe PrEP has most likely hastened HIV's considerable decline among white gay and bisexual men, but the HIV rate among Black and Latino gay and bisexual men has persisted at markedly high rates. In addition, when they are prescribed PrEP, Black gay men are less likely to take the pill regimen as prescribed. When they are taken daily, Truvada and Descovy each slash HIV risk by at least 99%. But inconsistent use diminishes PrEP's effectiveness. In late 2021, ViiV Healthcare's Apretude was approved as an injectable PrEP given every two months. Despite being much more effective than Truvada at lowering HIV cases across a population of gay and bisexual men and transgender women in a major clinical trial, Apretude has gained scant traction until recently. About 21,000 people are taking it, ViiV reported. It's possible that, in part, people have been alienated by the requirement to visit a clinic every two months for Apretude, instead of every three months for an oral PrEP prescription. The twice-yearly injection offers an alternative for people who won't or have trouble remembering to take a pill every day, reducing the number of required annual clinic visits from four to two. According to CDC estimates, during the decade after PrEP's debut, the annual HIV transmission rate declined by only 17%, from 38,300 cases in 2012 to 31,800 cases in 2022. Much of the decline occurred since 2018, with case numbers falling by 12% during that four-year period. In 2019, the Trump administration launched the Ending the HIV Epidemic, or EHE, initiative, which has since targeted nearly $3 billion in new spending to combat HIV, including by promoting PrEP, in 48 hot-spot counties in particular. The target jurisdictions had a swifter 21% decline in estimated HIV transmissions from 2018 to 2022. In a study published in October, CDC investigators reported that PrEP use has risen steadily since 2014 and that about 200,000 people were receiving some form of it during any month of 2023. But that is only a small fraction of the 1.5 million gay and bisexual men who are good PrEP candidates, according to estimates in a new CDC study published in May. The crucial question is whether a critical mass of people who otherwise wouldn't have stuck to an oral PrEP regimen can routinely be provided lenacapavir while they are at risk of HIV. Dr. Susanne Doblecki-Lewis, chief of the division of infectious diseases at the University of Miami Miller School of Medicine, is the site principal investigator for the lenacapavir clinical trial in gay men and a separate trial in people who inject drugs. She said lenacapavir could mitigate HIV-related racial disparities, provided it is made 'available easily and at low or no cost to people who can benefit from it who are uninsured or underinsured.' But, she said, 'if there are barriers, like complicated prior authorizations or high copays that will prevent people from easily starting it, we could see disparities just get worse.' The Trump administration's 2026 budget request seeks a $1.5 billion, or 35%, cut for domestic HIV funding. That includes shuttering the CDC's $794 million HIV-prevention division, although some remnants of it are apparently meant to be folded into a new federal health department, along with a maintained $220 million in EHE funding. Much of the CDC's HIV-prevention and -surveillance budget is distributed in grants to state and local health departments and nonprofit organizations. Severe federal budget cuts would most likely hobble those entities' efforts to educate at-risk populations and doctors about lenacapavir and provide services to facilitate its use. Another hurdle for prescribers is whether they can ensure that people at risk of HIV return for lenacapavir shots twice yearly. Two recent studies, one published in May and another presented at a conference in March, found that fewer than half of oral PrEP users stay on it for six months or longer. Historically, the National Institutes of Health has funded research to help implement new forms of PrEP, examining weak spots and devising interventions. But the Trump administration's campaign to slash NIH spending has had a severe impact on HIV research, including PrEP, according to a dossier of canceled grants compiled by a Harvard researcher. A federal judge ruled Monday that some such NIH grant terminations were 'arbitrary and capricious' and 'void and illegal.' But the temporary win for researchers doesn't mean the NIH under Trump will necessarily become newly hospitable to grant proposals concerning PrEP implementation. Johanna Mercier, Gilead's chief commercial officer, said in an interview this month that the company has been pushing insurers to cover lenacapavir. She expressed optimism for ultimately widespread coverage of the drug. Gilead will cover up to $7,200 annually in out-of-pocket costs for insured people receiving Yeztugo. And its patient assistance program will provide it free to low-income uninsured people. There is otherwise a patchwork system nationally that can often aid the uninsured in covering the required clinic visits and lab tests. Tristan Schukraft, CEO of the popular PrEP-focused telehealth company Mistr, said it intends to begin offering the drug immediately through its storefronts in seven major urban gay neighborhoods. The company has also formed partnerships with a nationwide network of community-based clinics that can provide the shots, including to people without insurance. 'We're ready,' Schukraft said. This article was originally published on
New York Times
17 hours ago
- Health
- New York Times
Regulators Approve a Twice-Yearly Shot to Prevent H.I.V. Infection
The Food and Drug Administration on Wednesday approved a twice-yearly injection that provided a near-perfect shield against H.I.V. infection in clinical trials. The approval is among the most anticipated developments in the prevention of H.I.V. But it arrives during deep cuts to global health programs that were expected to purchase and distribute the drug in low-income countries. To what extent the drug, called lenacapavir, can now be rolled out is uncertain. 'We're on the precipice of now being able to deliver the greatest prevention option we've had in 44 years of this epidemic,' said Mitchell Warren, executive director of the international H.I.V. prevention organization AVAC. 'And it's as if that opportunity is being snatched out of our hands by the policies of the last five months,' he said. With much less money available, governments abroad may instead choose to prioritize treatment of the infected. 'We were so excited about the possibilities,' said Dr. Linda-Gail Bekker, who led a clinical trial of the drug. 'I don't think any of us envisaged this year going quite the way it has.' Want all of The Times? Subscribe.
NBC News
18 hours ago
- Health
- NBC News
FDA approves powerful HIV drug that nearly eliminated spread in clinical trials
The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported Wednesday. In clinical trials, the drug nearly eliminated HIV's spread among people given an injection every six months. Called lenacapavir, the highly effective drug has inspired feverish anticipation among advocates for HIV prevention. The hope is the medication could accelerate the stubbornly slow decline of HIV transmission in the United States. 'This is the single best opportunity in 44 years of HIV prevention,' said Mitchell Warren, executive director of the HIV advocacy nonprofit group AVAC. Lenacapavir, which is given by health care workers in clinics, is significantly more effective than the existing oral HIV-prevention drugs, experts said, because it appears to address the challenges of sticking to a daily pill regimen for people who are at high risk of HIV. Gilead's chairman and CEO, Daniel O'Day, suggested in a statement Wednesday that lenacapavir could 'end the HIV epidemic once and for all.' Lenacapavir was approved after astounding results in Gilead's large clinical trials of the drug. The trials randomly assigned people at risk of HIV to receive either lenacapavir injections every six months or daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP. Among gay and bisexual men and transgender people, the lenacapavir group had an 89% lower HIV rate than a group taking Truvada and a 96% lower rate than Gilead estimated would have been expected absent any PrEP. In a similar trial among cisgender women in sub-Saharan Africa, no one who received lenacapavir contracted HIV. The drug the first in a new class of antiretrovirals which block HIV from infecting and making new copies of itself inside the immune cells it targets. Lenacapavir was first approved in 2022, under the brand name Sunleca, for use with other medications to treat highly drug resistant strains of the virus. All forms of PrEP work in the same way: If enough of the drug is present in the body when a person is exposed to HIV, it's highly effective at preventing the virus from taking hold and establishing a lifelong infection. Lenacapavir is so long-acting, it only needs to be injected twice a year. However, lenacapavir's use as PrEP against HIV emerges into a political climate that experts warn could derail progress against the virus' spread. The Trump administration's recent sweeping cancellations of research grants and its severe cuts to the Centers for Disease Control and Prevention's staffing have dramatically affected the HIV-prevention field in particular. HIV experts are concerned that lenacapavir's full potential might remain unrealized. Lenacapavir's cost could be another hurdle if health insurance companies don't pay for the new drug. Health insurers, at least in the near term, might decline to cover lenacapavir in favor of other forms of PrEP, including the cheaper generic version of Truvada pills, which cost as little as $30 per month. Or insurers might impose higher copays for lenacapavir, said Elizabeth Kaplan, director of health care access at Harvard Law School's Health Law and Policy Clinic. A pending Supreme Court decision concerning a pillar of the Affordable Care Act could also be a barrier to insurance coverage for medications that prevent HIV. The ACA, or Obamacare, mandates no-cost coverage for certain preventive interventions like PrEP. Mixed success for PrEP drugs Older forms of PrEP have had mixed success. Truvada, also made by Gilead, was the first approved PrEP drug in 2012, followed by a similar oral medication from the company, Descovy, in 2019. They have steadily gained popularity among gay and bisexual men, who, according to the CDC, account for 7 in 10 new HIV cases and comprise the overwhelming share of PrEP users. However, considering how much higher the HIV rate is among Black and Latino gay men compared with their white peers, PrEP use among men of color has remained disproportionately low. Experts believe PrEP has most likely hastened HIV's considerable decline among white gay and bisexual men, but the HIV rate among Black and Latino gay and bisexual men has persisted at markedly high rates. In addition, when they are prescribed PrEP, Black gay men are less likely to take the pill regimen as prescribed. When they are taken daily, Truvada and Descovy each slash HIV risk by at least 99%. But inconsistent use diminishes PrEP's effectiveness. In late 2021, ViiV Healthcare's Apretude was approved as an injectable PrEP given every two months. Despite being much more effective than Truvada at lowering HIV cases across a population of gay and bisexual men and transgender women in a major clinical trial, Apretude has gained scant traction until recently. About 21,000 people are taking it, ViiV reported. It's possible that, in part, people have been alienated by the requirement to visit a clinic every two months for Apretude, instead of every three months for an oral PrEP prescription. Lenacapavir has the potential, but will it deliver? Lenacapavir offers an alternative for people who won't or have trouble remembering to take a pill every day, and it reduces the number of required annual clinic visits from four to two. According to CDC estimates, during the decade after PrEP's debut, the annual HIV transmission rate declined by only 17%, from 38,300 cases in 2012 to 31,800 cases in 2022. Much of the decline occurred since 2018, with case numbers falling by 12% during that four-year period. In 2019, the Trump administration launched the Ending the HIV Epidemic, or EHE, initiative, which has since targeted nearly $3 billion in new spending to combat HIV, including by promoting PrEP, in 48 hot-spot counties in particular. The target jurisdictions had a swifter 21% decline in estimated HIV transmissions from 2018 to 2022. In a study published in October, CDC investigators reported that PrEP use has risen steadily since 2014 and that about 200,000 people were receiving some form of it during any month of 2023. But that is only a small fraction of the 1.5 million gay and bisexual men who are good PrEP candidates, according to estimates in a new CDC study published in May. The crucial question is whether a critical mass of people who otherwise wouldn't have stuck to an oral PrEP regimen can routinely be provided lenacapavir while they are at risk of HIV. Dr. Susanne Doblecki-Lewis, chief of the division of infectious diseases at the University of Miami Miller School of Medicine, is the site principal investigator for the lenacapavir clinical trial in gay men and a separate trial in people who inject drugs. She said lenacapavir could mitigate HIV-related racial disparities, provided it is made 'available easily and at low or no cost to people who can benefit from it who are uninsured or underinsured.' But, she said, 'if there are barriers, like complicated prior authorizations or high copays that will prevent people from easily starting it, we could see disparities just get worse.' Political challenges The Trump administration's 2026 budget request seeks a $1.5 billion, or 35%, cut for domestic HIV funding. That includes shuttering the CDC's $794 million HIV-prevention division, although some remnants of it are apparently meant to be folded into a new federal health department, along with a maintained $220 million in EHE funding. Much of the CDC's HIV-prevention and -surveillance budget is distributed in grants to state and local health departments and nonprofit organizations. Severe federal budget cuts would most likely hobble those entities' efforts to educate at-risk populations and doctors about lenacapavir and provide services to facilitate its use. Another hurdle for prescribers is whether they can ensure that people at risk of HIV return for lenacapavir shots twice yearly. Two recent studies, one published in May and another presented at a conference in March, found that fewer than half of oral PrEP users stay on it for six months or longer. Historically, the National Institutes of Health has funded research to help implement new forms of PrEP, examining weak spots and devising interventions. But the Trump administration's campaign to slash NIH spending has had a severe impact on HIV research, including PrEP, according to a dossier of canceled grants compiled by a Harvard researcher. A federal judge ruled Monday that some such NIH grant terminations were 'arbitrary and capricious' and 'void and illegal.' But the temporary win for researchers doesn't mean the NIH under Trump will necessarily become newly hospitable to grant proposals concerning PrEP implementation. Johanna Mercier, Gilead's chief commercial officer, said in an interview this month that the company has been pushing insurers to cover lenacapavir. She expressed optimism for ultimately widespread coverage of the drug. Gilead will cover up to $7,200 annually in out-of-pocket costs for insured people receiving lenacapavir. And its patient assistance program will provide it free to low-income uninsured people. There is otherwise a patchwork system nationally that can often aid the uninsured in covering the required clinic visits and lab tests. Tristan Schukraft, CEO of the popular PrEP-focused telehealth company Mistr, said it intends to begin offering lenacapavir immediately through its storefronts in seven major urban gay neighborhoods. The company has also formed partnerships with a nationwide network of community-based clinics that can provide the shots, including to people without insurance. 'We're ready,' Schukraft said.
Yahoo
02-03-2025
- Health
- Yahoo
USAID cuts could send global health into chaos
The Trump administration's decision to end almost all foreign aid spending from the United States Agency for International Development (USAID) is poised to plunge global health into chaos. The contract terminations announced Wednesday will end grants for HIV treatments and prevention, tuberculosis, polio, malaria, Ebola and numerous other diseases and conditions. Nutrition assistance programs for infants in developing countries have also been halted, organizations said. Nearly 5,800 projects funded by USAID have been terminated, ending the hope that contracts previously frozen might have been restarted. 'This reckless and unilateral move will cost millions of lives around the world,' said the Global Health Council, an alliance of nonprofit organizations and companies that receive U.S. foreign aid funding, in a statement. 'With the stroke of a pen, the U.S. government has gutted decades of progress in global health, development, and humanitarian aid — without due process, transparency, or good faith consideration of the consequences,' the council said. The Global Health Council is one of the nonprofits that have challenged a freeze on foreign aid. Shortly after taking office, the Trump administration suspended nearly all foreign assistance, saying the funds needed to undergo a 90-day review to ensure compliance with the administration's policies. The freeze led to thousands of humanitarian workers losing their jobs and life-threatening delays in food and medicine to impoverished areas around the world. A few days later, the State Department issued stop work orders on foreign assistance funded by or through the State Department and USAID, including existing awards. The stop-work orders came without warning, sowing immediate chaos and confusion. The State Department then issued waivers to allow certain 'lifesaving' programs, including the President's Emergency Plan for AIDS Relief (PEPFAR), to continue. But the waivers were unevenly applied, and organizations granted waivers said they still weren't being paid. International health groups said they were under the impression the waivers would continue to apply through the 90-day review period. 'The chaos and confusion of the last four weeks we thought had reached a fever pitch but what happened [Wednesday] night takes this to a new dimension. Every project imaginable in HIV, tuberculosis, malaria, nutritional support, has now been terminated,' said Mitchell Warren, executive director of AVAC, an international nonprofit focused on HIV prevention and one of the plaintiffs in the effort to unfreeze funding. 'The only strategy the administration seems to have is to sow chaos and confusion. There's no effort to look at what aligns with foreign policy, diplomacy, partnerships. And no strategy to prepare for public health threats,' Warren said. But on Wednesday night, the administration said it had concluded a 'a good-faith, individualized assessment' of USAID's 6,300 grants in less than a month. 'Secretary [of State Marco] Rubio has now made a final decision with respect to each award, on an individualized basis, affirmatively electing to either retain the award or terminate it pursuant to the terms of the instrument or independent legal authority as inconsistent with the national interests and foreign policy of the United States,' the administration said in a court filing. The State Department has said the agency spared critical awards for lifesaving medical treatment, including those that had been operating under a waiver from the earlier funding freeze, but health groups say that is not the case. For instance, the Elizabeth Glaser Pediatric AIDS Foundation said three of its primary USAID agreements, which had received approval to resume limited work under the State Department's waiver for lifesaving work, were terminated. The projects supported more than 350,000 people on HIV treatment, including nearly 10,000 children and more than 10,000 HIV-positive pregnant people in Lesotho, Eswatini, and Tanzania. The International Rescue Committee (IRC) said 46 of its USAID and State Department programs were canceled, including funding for operating nutrition assistance centers, which help severely malnourished children. Those had been operating under a waiver. The Joint United Nations HIV/AIDS program said its U.S. government funding was also terminated. Global health experts said the effects of the cuts will be disastrous, both in terms of health and for how the U.S. is seen throughout the rest of the world. If a person with HIV stops taking the medication, the virus is no longer suppressed and can multiply, leading to weakened immune systems, illness and then potential spread to others. For malaria, the cuts mean programs that supplied mosquito nets for cribs won't continue, which means fewer babies protected from malaria. That increases malaria infections, which then can increase deaths. 'It's just a cascading effect on almost every level that ultimately leads to more people being ill, more people dying, and ultimately more costs associated with running these programs and caring for these people,' said Jirair Ratevosian, a fellow at Duke University's Global Health Institute who worked as a chief of staff for the PEPFAR program. 'So it's counterintuitive to what we're trying to do.' Jen Kates, a senior vice president and director of the Global Health & HIV Policy Program at KFF, said the terminations could set back years of health progress that the U.S. and others have been working toward in developing countries. 'The U.S., frankly, has been one of the main forces behind health achievements in low- and middle-income countries. So a lot of money was provided to make these gains, and they could be set back,' Kates said. 'The extent of the damage is not known yet, but I think in a lot of cases it might be hard to recover easily, even with the replacement funds at some point in the future.' Jocelyn Wyatt, CEO of the aid group Alight, said she had to terminate programs for millions of displaced people in Sudan, Somalia and South Sudan. Wyatt said Alight was the largest health provider in Sudan, serving 2.1 million people. They operated under a waiver during the earlier funding freeze, but this week had to close 33 health clinics in the country. In Somalia, the group had to close 13 health centers, as well as a mobile clinic. In Sudan, it had to stop water and sanitation services and close three camps for displaced people and refugees. 'We're working in very remote regions. Humanitarian assistance was already very scarce. There were not a lot of services before, and now there's none,' Wyatt said. 'These are lifesaving services. There's no alternative, and people will die.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
