Latest news with #AVAC
Yahoo
2 days 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
2 days 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.
The Star
10-06-2025
- Business
- The Star
Vietnam exports first African swine fever vaccine batch to Indonesia
Workers at AVAC Vietnam preparing a shipment of African swine fever vaccine for export to Indonesia. — Courtesy of AVAC HANOI: Biotechnology firm AVAC Vietnam Joint Stock Company has exported its first shipment of African swine fever (ASF) vaccines to Indonesia, a major milestone in the country's efforts to bring domestically developed veterinary vaccines to the international market. The shipment, consisting of 120,000 doses of the AVAC ASF LIVE vaccine, was sent to Indonesia on Monday following nearly three years of evaluation and testing in collaboration with Indonesian authorities. The vaccine was officially approved for use by Indonesia's Ministry of Agriculture in April this year. The importer and distributor is PT. Biotis Prima Agrisindo, based in West Java. According to Nguyen Van Diep, General Director of AVAC Vietnam, the export underscores the vaccine's quality and efficacy, having passed Indonesia's stringent veterinary approval process. He said the milestone reflected not only the company's success but also the progress of Vietnam's veterinary vaccine sector in establishing a presence on the global stage. The live attenuated vaccine is the first of its kind in the world to have been successfully developed and commercialised, a result of intensive research by AVAC. The product has so far been used to administer over 3.5 million doses, with around three million doses deployed across Vietnam to help contain ASF outbreaks in various localities. Nearly 500,000 doses have already been exported to the Philippines and Nigeria, both of which have responded positively to the vaccine. AVAC currently maintains a reserve of approximately 1.5 million doses to meet urgent domestic and international demand. The company is also pursuing regulatory approval in several other countries, including India, Malaysia, Nepal and Myanmar. In Vietnam, the vaccine has been rolled out on a large scale in provinces such as Cao Bang, Lang Son, Bac Ninh, Hai Duong, Hai Phong, Quang Ninh, Quang Ngai and Tra Vinh, with the support of local funding. Field results have shown the vaccine to be highly effective and safe, with no recurrence of ASF in vaccinated herds. Veterinary authorities are continuing to assess the vaccine's use in breeding pigs, including both sows and boars, to extend protection across the entire pig population. Initial trials have indicated good safety and efficacy, though full evaluation is still underway. Le Toan Thang, head of Veterinary Medicine Management Division at the Department of Livestock Production and Animal Health, said the successful export to Indonesia further demonstrated the effectiveness of Vietnamese-made vaccines. He said that Vietnam's ability to control ASF domestically helped build trust in the product and opened the door for more exports. All exported veterinary vaccines must undergo rigorous testing, independent trials and safety assessments in the importing country before they are approved for use. AVAC's product has successfully met these standards. AVAC is one of three domestic manufacturers currently licensed to produce ASF vaccines in Vietnam, alongside Navetco Central Veterinary Medicine JSC and Dabaco Group. — Vietnam News/ANN
Yahoo
11-02-2025
- Politics
- Yahoo
Nonprofits sue Trump administration for freezing foreign aid
A liberal-leaning advocacy group filed a lawsuit against the Trump administration Monday seeking to halt the freeze on foreign aid the administration has imposed. The group, Public Citizen, argues the freeze on funds appropriated by Congress is unlawful and is endangering lives abroad. 'When programs like the ones run by our clients are abruptly shuttered, the impacts are felt throughout the world — with the most vulnerable people bearing the deadliest impact,' Public Citizen attorney Lauren Bateman, the lead lawyer on the case, said in a statement. The Trump administration's sudden halt on U.S. foreign aid last month caused chaos and confusion inside groups providing a range of assistance to other countries, from providing health care to removing land mines. The funding freeze led to mass layoffs at contractors who work for the government, as well as grantees. They warned the freeze would decimate the firms that carry out the work and significantly hamper the government's ability to deliver foreign aid in the future. Secretary of State Marco Rubio said that the freeze was necessary to review U.S. foreign aid spending and ensure that it aligns with President Donald Trump's 'America First' foreign policy. The administration has pointed to grants and contracts it says don't meet that definition and, in the administration's view, seek to advance progressive causes, like LGBTQ+ rights. But global health and development advocates warned that the sudden stop to existing grants and contracts was unnecessary and cruel and would make the U.S. look unreliable, potentially leading countries that benefit from American foreign aid to turn to U.S. rivals like China. Public Citizen filed the lawsuit in federal district court in Washington on behalf of the AIDS Vaccine Advocacy Coalition, or AVAC, and the Journalism Development Network, or JDN. AVAC is a New York-based nonprofit which received a grant from the President's Emergency Plan for AIDS Relief, better known as PEPFAR, to support biomedical HIV prevention research in Africa. JDN received grants from the State Department and the U.S. Agency for International Development to help foreign journalists do their work. Both organizations have been unable to access grant funding since the freeze, Public Citizen wrote in its complaint. AVAC has laid off 7 of its 46 employees, while JDN has laid off a fifth of its staff, according to the complaint.
New York Times
08-02-2025
- Business
- New York Times
With Aid Cutoff, Trump Severs a Lifeline for Millions
Funds from the world's richest nation once flowed from the largest global aid agency to an intricate network of small, medium and large organizations that delivered aid: H.I.V. medications for more than 20 million people; nutrition supplements for starving children; support for refugees, orphaned children and women battered by violence. Now, that network is unraveling. The Trump administration froze foreign aid for 90 days and has planned to gut the U.S. Agency for International Development to just 5 percent of its work force, although a federal judge paused the plan on Friday. Given wars and strapped economies, other governments or philanthropies are unlikely to make up for the shortfall, and recipient nations are too hamstrung by debt to manage on their own. Even the largest organizations are unlikely to emerge unscathed. In interviews, more than 25 aid workers, former U.S.A.I.D. employees and officials from aid organizations described a system thrown into mass confusion and chaos. A tower of blocks may take hours to build, but 'you pull one of those blocks out and it collapses,' said Mitchell Warren, executive director of the H.I.V. prevention organization AVAC, which relied on U.S.A.I.D. for 38 percent of its funding. 'You've gotten rid of all of the staff, all of the institutional memory, all of the trust and confidence, not only in the United States but in the dozens of countries in which U.S.A.I.D. works,' Mr. Warren said. 'Those things have taken decades to build up but two weeks to destroy.' Small organizations, some with as few as 10 employees, have folded. Some midsize organizations have furloughed up to 80 percent of their employees. Even large organizations — including Catholic Relief Services and FHI 360, among the biggest recipients of U.S.A.I.D. funding — have announced large layoffs or furloughs. In one survey, about 1 in 4 nonprofits said they might last a month; more than half said they had enough reserves to survive for three months at most. The damage is compounded by President Trump's announcement that the United States would withdraw from the World Health Organization, forcing its leaders to announce cost-cutting measures of their own. Global health experts said that the future suddenly looked uncertain, even dystopian, and struggled to articulate alternatives. 'We are quite clear that the future looks different,' said Christine Stegling, a deputy executive director at UNAIDS, the United Nations' H.I.V. division. But 'none of us yet has a real picture of what that means.' The damage extends not just to the health of people abroad but to Americans and American businesses. Along with the roughly 100,000 positions cut overseas, an estimated 52,000 Americans in 42 states have lost their jobs. The global health care supply chain market was valued at nearly $3 billion in 2023 and was expected to grow. Each year, about $2 billion in American agricultural products were purchased as food aid. The abrupt halt risks more than $450 million worth of corn, lentils, rice and other commodities that are in transit or in warehouses and ports. 'The economic impact of this is going to be astounding to people's lives and businesses,' said Lisa Hilmi, executive director of CORE group, a consortium of large global health practitioners. Ms. Hilmi, who worked as a nurse in many conflict and disaster zones, said that a lack of health services could drive poor health, malnutrition, epidemics, civil unrest and 'a much broader meltdown of society across the world.' 'If America is the biggest superpower, then we need to act like it,' she said. 'And part of that is acting with humanity.' 'Dizzying chaos' A week after the aid was paused, Secretary of State Marco Rubio issued a waiver for lifesaving humanitarian assistance and medications. But stop-work orders for some programs, including food assistance, followed even after the waiver's announcement. Last week, one large organization got the go-ahead for some of its programs. But later that same day the Trump administration placed dozens of U.S.A.I.D. officers on leave, leaving the organization wondering whether the division that issued the waiver was still a viable entity and the officer who wrote the notice was still employed. 'It's another example of the dizzying chaos that this administration has inflicted on us,' said a senior official at the organization. The leaders of most organizations that depend on U.S.A.I.D. funding would not speak on the record, fearing retaliation from the Trump administration. Even when organizations have received approvals to continue, no money has flowed. One large organization received less than 5 percent of its expected budget for the period, but others have received nothing. 'I obviously welcome that the secretary approved a waiver and put a post on the internet, but we cannot pay our bills with the post,' a senior official at a large organization said of Mr. Rubio. Some groups feel morally obligated to continue to provide lifesaving services, hoping that they will eventually be reimbursed. But with dozens of small organizations shuttering by the day, damage to some of the world's most vulnerable groups is accruing, some experts warned. The ecosystem of global health is so closely interwoven that the pause has frozen the work even of organizations that receive no money from the U.S. government. The nonprofit IPAS works with hundreds of organizations in dozens of countries to provide access to contraception, abortion and other reproductive health services. Many of the clinics have shuttered, some permanently, said Anu Kumar, the organization's president. The speed of the disruption did not allow clinics time to make contingency plans or taper their dependence on the funding, she said, adding, 'This definitely has a ripple effect.' After one week of the freeze, more than 900,000 women and girls will have been denied reproductive care, a figure that will grow to 11.7 million over the 90-day pause, according to the Guttmacher Institute. 'That's more than the entire population of North Carolina,' Dr. Kumar said. As a result, the institute estimated, 4.2 million girls and women will experience unintended pregnancies, and 8,340 will die from complications during pregnancy and childbirth. Many H.I.V. programs were focused on 'key populations' at highest risk, including transgender people and men who have sex with men, who are marginalized and even criminalized in some countries. In Uganda, for instance, where a harsh anti-gay law can carry the death penalty for consensual homosexual activity for people with H.I.V., nonprofit groups funded by the United States have been crucial sources of financial and medical support. 'It's something every American should be proud about, but I don't think they know it,' said Kenneth Mwehonge, executive director of the Coalition for Health Promotion and Social Development, which monitors the quality of other H.I.V. programs in Uganda. 'I don't think they know how much they've contributed and the lives they've saved, and they don't celebrate it enough,' he said. His organization has had to let go of 140 full-time staff members and community workers. Childhood immunizations, malaria prevention and treatment and malnutrition programs are also stalled. So are programs on education, economic empowerment, preventive health services and family planning. 'This is a perfect storm for poor health outcomes, no getting around it,' said Elisha Dunn-Georgiou, executive director of the Global Health Council, a membership organization of health groups. Some U.S.A.I.D.-funded organizations provided clean water and sanitation, particularly for refugee populations. Others helped governments protect against diseases like polio and measles in conflict zones and among nomadic groups. Still others provided expertise in containing outbreaks of dangerous pathogens like Ebola and Marburg, which are smoldering in Uganda and Tanzania. Any of these threats, if not contained, could easily cross borders and land on America's shores, said Rebecca Wolfe, who worked at the U.S.A.I.D.-funded nonprofit Mercy Corps for 15 years and is now a development expert at the University of Chicago. The world 'is so interconnected, and to try to divide it into 'America first' and the rest no longer works in today's age,' she said. 'It feels like grief' Some U.S.A.I.D. employees and aid organizations said that the sudden unplugging of funding was antithetical to the goal: helping countries become independent enough to care for their own citizens. In the past few years, U.S.A.I.D. has been working on training midwives, nurses, doctors, laboratories and hospitals to begin to transfer the responsibility. Self-sufficiency would require small nonprofits at the local level to deliver services, but the smallest organizations are also the least likely to weather the current storm. 'The irony is that their priority in Project 2025 is localizing and moving away from big partners,' said Jeremiah Centrella, former general counsel at Mercy Corps. 'But big international partners are the only ones with access to private donors and strong enough balance sheets to get through this.' It's unclear what will happen to the tens of thousands of workers who suddenly have no jobs and no industry in which to find one. In Kenya, Mercy Githinji cared for 100 households in the Kayole neighborhood of Nairobi when the clinic where she worked, run by the U.S.A.I.D. Tumukia Mtoto Project, abruptly closed down. Now Ms. Githinji, a 52-year-old single mother of four daughters, is unsure how she will pay rent or school fees. The clinic provided medical care but also helped residents with rent money, food and sanitary pads. 'Now there's no check, there's nothing,' Ms. Githinji said. 'It's very bad. People are suffering.' Even if aid were to resume next week, clinics and offices have already closed, people have moved, and trust has been broken, some former U.S.A.I.D. employees said. Others said they were desperately saddened — not for themselves, but for the people they had pledged to serve. 'The only way I have been able to describe it is, it feels like grief,' one former U.S.A.I.D. employee said. 'Our mission is to save lives and alleviate suffering,' she said. 'Not having the opportunity to contribute to that, and have it be taken away overnight, arbitrarily, without notice or reason, being called a criminal or radical lunatic, has just been deeply heartbreaking.'
