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Reuters
3 days ago
- Business
- Reuters
Gilead commits to HIV prevention rollout for low-income countries despite funding uncertainty
May 30 (Reuters) - Gilead Sciences says it still plans to supply its twice-yearly injection for preventing HIV infection in low-income countries if it wins U.S. approval despite funding uncertainty over the Trump Administration's pullback in aid spending. Some AIDS experts, including activists and doctors, say the Gilead drug, lenacapavir, could help end the 44-year-old epidemic that infects 1.3 million people a year and is estimated by the World Health Organization to have killed more than 42 million. An FDA approval decision is expected by June 19 for lenacapavir, which proved to be nearly 100% effective at preventing HIV in large trials. If the Food and Drug Administration green lights the drug, and its view is seconded by the WHO, the shots could start to roll out early in 2026 to at least 2 million people in 18 low-income countries based on Gilead's agreement with the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, a worldwide partnership targeting HIV, tuberculosis and malaria. Gilead agreed to provide lenacapavir at cost for two-to-three years while six generic drugmakers, which were granted licenses to make the medicine for low-income countries, ramp up production. Experts said a successful launch of a long-acting HIV prevention drug could help stall the epidemic. Until recently, the only pre-exposure prophylaxis (PrEP) options for people at high risk of infection were daily pills, requiring careful adherence to be effective. "You can foresee a day where there are no new HIV diagnoses. It doesn't happen if we only do this in the U.S.," Gilead Chief Commercial Officer Johanna Mercier said. "We need to make sure we have a global approach to this launch." PEPFAR being part of the effort is Gilead's intent and goal, Mercier said. "Unfortunately, if they're not part of that mix, our goal is still to meet that objective of 2 million people getting access." Wall Street has a close eye on lenacapavir, one of the highest-profile drugs to undergo FDA review since President Donald Trump named Robert F. Kennedy Jr. as health secretary and promised to upend the status quo. Most of the drug's profits are expected in the U.S., with annual sales reaching $1 billion by next year, according to analysts' estimates compiled by LSEG. Whether all of the agreed funding for low-income countries - most of which are in Africa - will come through is unclear. Countries that rely on aid are already reeling from funding cuts by the Trump Administration, including to PEPFAR, and AIDS researchers are bracing for the worst. The United Nations program on HIV/AIDS earlier this month said many HIV prevention programs supported by PEPFAR were stalled, although services for pregnant and breastfeeding women were technically exempt from the cuts. Peter Sands, executive director of the Global Fund, told Reuters the group intends to fund as much of the lenacapavir rollout as possible, but it will need to start slowly. "It's not just the uncertainty over PEPFAR's funding that's an issue, but the uncertainty over our funding," Sands said, adding that the group's first priority is treating people already infected with the deadly virus. Much will depend on the success of the Global Fund's effort to raise $18 billion to fund its work from 2027-2029. The U.S. is its largest donor, committing $6 billion in the previous funding round. It is unclear what the U.S. may provide this round, or whether other big governments will step up. UNAIDS estimates that the permanent discontinuation of HIV prevention and treatment programs supported by PEPFAR would lead to an additional 6.6 million new HIV infections between 2025 and 2029. The U.S. State Department, which oversees PEPFAR, did not respond to a request for comment. Gilead declined to comment on its manufacturing cost for lenacapavir, whose U.S. price is likely to be on par with current preventive medications at around $25,000 per year. ViiV Healthcare's Apretude, an injection given every two months, costs about 124.20 pounds ($168) in low- and middle-income countries. Mitchell Warren, executive director of the AIDS nonprofit AVAC, estimates the eventual annual cost at $100-$120. The lower the price, the more people who could receive it, he said. Warren said PEPFAR could still participate, and others may come forward. The Gates Foundation and the Children's Investment Fund Foundation are "actively involved in all of these conversations," he said, as is the Elton John AIDS Foundation. Linda-Gail Bekker of the University of Cape Town, who led lenacapavir clinical trials in South Africa and Uganda, said she was elated when she first saw the findings. "The huge feeling I have now is one of incredible dismay," said Bekker of uncertainty over the Trump administration's commitment to PEPFAR and HIV prevention in poor nations. "It felt like the stars were aligning, and one of the stars has fallen out of the sky."
Business Wire
08-05-2025
- Health
- Business Wire
VirTus Respiratory Research Ltd的人体鼻病毒攻毒模型研究结果推动Altesa BioSciences的主导药物进入高级临床试验阶段
伦敦--(BUSINESS WIRE)--(美国商业资讯)-- 专注呼吸系统研究的知名合同研究公司VirTus Respiratory Research Ltd今日宣布，其针对慢性阻塞性肺疾病（COPD）患者开展的鼻病毒人体攻毒模型研究结果，为Altesa BioSciences提供了关键证据，支持将其主导候选药物vapendavir推进至大规模后期临床试验阶段。 鼻病毒感染是导致数百万慢性阻塞性肺病患者出现急性呼吸功能恶化的主要原因，占比至少50%。Altesa首席执行官、美国前卫生部助理部长兼FDA代理局长Brett Giroir博士表示，'在投入数千万美元将vapendavir推进至涉及数千名患者的临床试验之前，通过概念验证研究证实该药物的疗效至关重要。经过全球范围的严格筛选，我们确认VirTus是唯一能够安全、有效且可靠地在真实COPD志愿者中开展此项研究的机构。' 这项随机、安慰剂对照研究招募并评估了40名慢性阻塞性肺病（COPD）志愿者，COPD是全球第三大死亡原因。经过预先筛查的COPD受试者在接种已知安全型鼻病毒毒株后，于症状出现时完成随机分组。本次研究将精准社交媒体推广作为主要招募渠道，触达逾万名潜在志愿者，这一创新性招募策略充分彰显了VirTus为确保受试者高效入组所采用的先进方法。 VirTus联合创始人兼首席医疗官Sebastian Johnston教授表示，'这些积极成果印证了我们人体病毒攻毒模型能够有效地在新药临床研发早期快速评估疗效。该方法能让生物科技和制药合作伙伴获得具有临床意义的早期数据，帮助他们在药物研发管线中做出可靠的继续/终止决策。' VirTus人体病毒攻毒模型为临床试验主办方提供了在受控环境下评估治疗方案的机会，与传统的大规模早期临床开发研究相比，可显著降低不确定性并大幅缩减时间和成本。 Altesa首席医学官、GSK前首席医学官Kate Knobil博士表示，'借助Johnston教授及VirTus团队的丰富经验，我们已掌握如何最优使用vapendavir，使其最大程度改善COPD患者的生活质量——这正是我们矢志追求的终极目标，也是我毕生职业生涯的奋斗方向。' VirTus联合创始人兼董事总经理Michael Edwards博士补充道，'我们非常荣幸能支持Altesa BioSciences取得vapendavir的这些鼓舞性成果。此次成功合作彰显了我们人体攻毒研究的优势与可靠性，进一步强化了我们加速全球呼吸道疾病创新疗法开发的使命。' 关于VirTus Respiratory Research Ltd VirTus Respiratory Research Ltd是由英国帝国理工学院Sebastian Johnston教授与Michael Edwards博士共同领导的合同研究组织（CRO）。VirTus专注于加速呼吸道病毒感染治疗与预防新疗法的开发——这类感染正是哮喘、慢性阻塞性肺疾病（COPD）及支气管扩张等慢性呼吸系统疾病急性发作的首要诱因。VirTus开展从临床前到早期阶段的临床研究，其专长的人体病毒攻毒模型可生成高质量数据，为创新疗法推进至后期研发阶段提供关键支持。 鼻病毒攻毒模型 VirTus Respiratory Research Ltd使用鼻病毒攻毒模型在严格受控、可重复的实验环境中，产生药物临床疗效的早期信号。该模型通过对志愿者实施监测条件下的鼻病毒感染，可全面评估治疗方案对症状、病毒载量及免疫/炎症反应的影响。对合作伙伴而言，这一模型是在开展规模更大、成本更高的IIb/III期试验前至关重要的"继续/终止"决策工具。它能在早期解答包括临床疗效、剂量选择和终点指标优化等关键问题。主办方可借此缩短研发周期、提前获得'继续/终止'决策依据，通过在早期阶段识别有潜力的候选药物或排除无效方案来降低研发风险，最终实现资源优化配置并提高后续研发成功率。 关于Vapendavir 口服片剂vapendavir是一款处于临床阶段的抗病毒药物，对97%的测试鼻病毒株及其他呼吸道肠道病毒均表现出强效活性。该药物通过双重作用机制起效：既能阻断病毒侵入人体细胞，又可抑制病毒复制。目前，Vapendavir针对COPD患者鼻病毒感染的适应症已进入后期临床试验阶段。其作用机制与Gilead Sciences已获FDA批准的HIV衣壳抑制剂lenacapavir类似。 关于COPD 慢性阻塞性肺疾病（COPD）是一种影响全球数亿患者的致命性慢性肺部疾病。作为当前全球第三大死因，COPD患病率随着人口老龄化及持续暴露于吸烟、空气污染等风险因素而不断攀升。该疾病给患者个体和医疗系统均带来沉重负担：一方面因进行性肺功能衰退和频繁急性加重导致高发病率；另一方面长期治疗及反复住院产生的巨额医疗费用（仅美国每年就高达490亿美元）也造成巨大经济压力。 关于Altesa Altesa BioSciences是一家临床阶段制药公司，致力于为人类健康长期面临的重大威胁——高致病性病毒感染，开发新型疗法。这类感染对脆弱人群的影响尤为严重，包括肺部疾病等慢性病患者、老年人以及医疗服务不足社区的众多群体。 免责声明：本公告之原文版本乃官方授权版本。译文仅供方便了解之用，烦请参照原文，原文版本乃唯一具法律效力之版本。
Yahoo
26-02-2025
- Politics
- Yahoo
USAID workers told to leave; PEPFAR funding protesters arrested
Feb. 26 (UPI) -- Several protesters were arrested Wednesday after U.S. Agency for International Development workers were told via a text message to pack their belongings and leave on Tuesday. "All staff and their property will undergo magnetometer and X-ray machine screening upon entry. Staff will then be escorted to their workspace, where they will be permitted to collect their personal items and given approx [sic] 15 minutes to complete this retrieval and must be finished removing items within their time slot only," the message told workers on Tuesday, WPRI reported. The message said USAID workers must bring their own boxes, tape or other containers needed to remove their personal items. The Trump administration on Sunday announced 1,600 USAID workers would be fired and another 4,200 would be placed on administrative leave. USAID reported having 14,000 employees prior to the Trump administration officials announcing their intent to dismantle the federal agency. The administration's efforts triggered a protest Wednesday at the Cannon House Office Building, where Capitol Police arrested about 21 protestors opposed to a freeze on funding for foreign aid, including the U.S. President's Emergency Plan for AIDS Relief, the New York Times reported. Several protesters carried signs and wore shirts that read: "Stop The Deadly Global AID Freeze" with a red hand print depicted and "Save PEPFAR Now!" USAID administered PEPFAR funding prior to the funding freeze and the agency's current dismantling by the Trump administration. U.S. District Court for Washington, D.C., Judge Amir Ali on Tuesday ordered the Trump administration to end its funding freeze on foreign aid by midnight Wednesday after administration officials ignored a prior court order made 12 days earlier, NPR reported. Ali on Feb. 13 ordered the Trump administration to release hundreds of millions of dollars in USAID payments for international projects, but those funds have not been released. The funds were not released as of Tuesday, but Ali declined to hold the Trump administration in contempt of court and instead gave it through Wednesday to release the frozen funds. The frozen funds include PEPFAR funding for HIV prevention and treatment services in 55 nations, Public Health Newswire reported. The Department of State on Feb. 1 limited PEPFAR funding to focus on preventing AIDS transmission between mothers and their children. The limited PEPFAR funding could lead to more than 600,000 HIV-related deaths and 565,000 new HIV infections in South Africa, according to a study published Feb. 11 in the Annals of Internal Medicine. The funding freeze also endangers the continued use of HIV prevention drug lenacapavir, which the U.S. Food and Drug Administration has not approved for use in the United States but is targeted for use in 2 million people overseas. The State Department indicated PEPFAR funding accounts for 90% of the medication's use around the globe. "Activists have spent four decades fighting for expanded government investment to prevent, treat and ultimate end HIV," Treatment Action Group Executive Director Mark Harrington said in a statement on Feb. 6. "We're unwilling to stand by and let the new administration destroy decades of progress against one of the world's deadliest pandemics." Members of HIV/AIDS advocacy group Housing Works also protested the freeze in PEPFAR funding on Feb. 6 in Washington, D.C.
