Islatravir

默沙东将在IAS 2025发布其HIV预防和治疗管线研究进展该下一代CD3/CD19 双特异性抗体对于B细胞恶性肿瘤和自身免疫性疾病具有应用潜力将增强并丰富默沙东的在研管线美国新泽西州罗威市，2025年7月8日——默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）宣布，公司将在2025年7月13日至17日于卢旺达基加利举行的第十三届国际艾滋病协会（IAS）HIV科学会议（IAS 2025）上展示其HIV预防和治疗管线的最新研究进展。默沙东将发布其HIV临床研发项目中的全新科学数据，包括针对MK-8257[1]安全性和药代动力学分析的II期研究数据，MK-8257是一款在研新型核苷类逆转录酶易位抑制剂（NRTTI），每月口服一次，研发用于HIV暴露前预防（PrEP）。IAS 2025会议上将发布三项III期研究数据（P051: NCT05631093; P052: NCT05630755; P054: NCT05766501），评估前病毒DNA中预存耐药相关突变（RAMs）对于多拉韦林/Islatravir[2]（DOR/ISL）病毒学应答的影响。此外，针对每周口服一次的islatravir和ulonivirine[3]（ISL/ULO）组合方案的临床研发项目也将公布研究数据。其中包括两项I期研究，评估ulonivirine每周口服一次的安全性和耐受性以及islatravir和ulonivirine在未感染HIV成人中每周剂量的药物相互作用；一项IIb期剂量探索研究，评估使用较高剂量（20mg）的islatravir和三种剂量的ulonivirine 用于未经治疗的HIV-1感染成人患者。基于这些临床试验结果以及此次会议期间将要展示的药代动力学模型，islatravir（2mg）和ulonivirine（200mg）（MK-8591B）每周口服一次的组合方案正在推进临床开发。Elizabeth Rhee博士默沙东实验室全球临床开发副总裁“随着我们持续推进HIV领域的研究，我们很高兴在IAS 2025上展示HIV研发管线的最新数据，包括来自核苷类逆转录酶易位抑制剂研发项目的新数据，通过开发每日、每周和每月的口服方案，我们希望能够为感染或受HIV影响的人提供更多选择，以满足不断变化的需求。”今年IAS会议期间，默沙东将于中部非洲时间（CAT）7月15日18:00–19:30 举办政策研讨会“Harnessing the Private Sector to Deliver HIV Prevention”；以及于7月16日2:15–13:15 CAT举办医学研讨会“Let’s Talk About It – Practical Case Discussions”，探讨如今治疗HIV的关键考虑因素，以及基于III期研究数据深入探讨DOR/ISL的耐药性特征。这两项活动对IAS 2025注册参会者线上和现场开放。此外，默沙东将于美国东部时间7月17日上午9时举办线上投资者活动，分享公司在HIV治疗和预防方面的前沿研究管线。投资者、分析师、媒体以及公众可通过阅读原文访问活动。关于默沙东在HIV领域的承诺默沙东在HIV领域已有超过35年的持续投入，致力于通过科学研发进展与突破帮助改变HIV治疗格局。我们已创新引领多种药物类别的研发并帮助那些受到HIV影响的人。目前，我们正在开发一系列抗病毒药物，旨在帮助人们管理和预防HIV，以期减少全球范围内不断增加的感染负担。我们希望人们的生活不再被HIV所限，并持续通过变革性创新、全球HIV社群合作、以及提升可及性等多重努力，助力终结HIV流行的目标。[1] 截至目前，MK-8257尚未获中国国家药品监督管理局（NMPA）的批准[2] 截至目前，多拉韦林/Islatravir尚未获NMPA的批准[3] 截至目前，islatravir和ulonivirine尚未获NMPA的批准若您想了解更多有关疾病知识的信息，请咨询医疗卫生专业人士08-2025-CN-DOR-00320关于默沙东在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。130多年来，我们通过研发重要药物和疫苗，为全人类带来希望。我们致力成为顶尖的研究密集型生物制药公司——当下，我们正处于研发前线，推出创新解决方案，以推进人类和动物疾病的预防和治疗。我们建立了一个多元、包容的全球员工体系，以负责的态度经营每一天，确保所有人、所有社区都能有一个安全、可持续和健康的未来。更多信息，请访问www.msd.com，并在X（前身为Twitter）、LinkedIn和Youtube平台关注我们。关于默沙东中国中国是默沙东全球增长战略中至关重要的一部分。默沙东中国总部设在上海，同时在北京设有研发中心、在杭州、宁波和天津分别设有工厂，实现了研发、制造和商业运营三擎合一。我们全心全意，向中国大众提供高质量的创新药物、疫苗和服务，造福中国社会。更多信息，敬请访问默沙东中国官网，或关注默沙东中国在微信上的官方社交媒体账号。默沙东前瞻性声明默沙东是美国新泽西州罗威市默克公司的公司商号（下称“公司”）。本新闻稿包含根据《1995 年美国私人证券诉讼改革法案》之安全条款而做出的“前瞻性声明”。本文内容基于公司管理层当前的看法和预期，并且受制于可能出现的重大风险和不确定因素。默沙东不保证在研产品能获得所需的监管部门批准或取得商业成功。如果相关假设与现实有所出入、出现风险，或发生不确定情况，实际结果可与前瞻性声明中的预期有实质上的差异。风险和不确定因素包括但不仅限于一般行业情况与竞争、一般经济因素（包括利率与汇率浮动）、美国及其他国家制药行业监管以及医疗政策的影响、全球范围内控制医疗成本的趋势、技术发展、竞争对手获得的新产品与专利、新产品开发固有的挑战（包括获得监管部门批准）、默沙东对未来市场形势做出准确预测的能力、生产上的困难或迟延、国际经济金融状况不稳定与主权风险、对默沙东专利和其它创新产品保护的有效性的依赖程度，以及公司面临专利诉讼和/或监管行动的风险。默沙东没有义务就新信息、未来事件或其它原因对任何前瞻性声明进行公开的更新。尚有其它因素可能导致实际结果与前瞻性声明存在实质性差异，请参见默沙东2024年年报10-K报表以及公司在美国证券交易所备案的其它文件（可在美国证券交易所网站www.sec.gov上查阅）。

iStock, MotionIsland HIV pharma leaders are in Kigali, Rwanda for IAS 2025, touting their latest advancements in HIV and PrEP development on the heels of the landmark Yeztugo approval. The HIV space saw a historic moment last month with the approval of Gilead’s Yeztugo, a long-acting preventive injectable for HIV. Yeztugo isn’t the first long-acting pre-exposure prophylactic option—ViiV Healthcare’s Apretude also provides prolonged protection—but Gilead’s option only needs to be dosed twice a year, giving patients a more convenient option. Analysts and global health authorities have lauded the approval, with Mizuho at the time saying that Yeztugo “has the potential to ‘redefine’ the PrEP market.” The annual meeting of the International AIDS Society (IAS) is riding these tailwinds. The conference, currently being held in Kigali, Rwanda, is headlined by pharmas with some of the biggest developments in the field presenting the latest developments in their pipelines. BioSpace looks at some of the most interesting presentations here. Gilead Broadens Evidence Base for Yeztugo in Pregnancy and Young People On Thursday, Gilead will present additional data from its Phase III PURPOSE program for Yeztugo, showing that the drug was “efficacious and well tolerated” when used in different vulnerable patient populations. In the PURPOSE 1 study, which enrolled cisgender women and adolescent girls across sub-Saharan Africa , none of the 184 pregnant and lactating women treated with Yeztugo contracted HIV, according to a press announcement on Monday. The twice-yearly PrEP injection was also safe in these women, with no notable differences in adverse events compared with non-pregnant women. Infant exposure through breastfeeding was also “minimal,” according to Gilead. Meanwhile, data from PURPOSE 1 and PURPOSE 2—which together encompass a geographically and gender diverse population—showed that Yeztugo maintained its efficacy in young people aged 16 through 25 years. In this age group, only two cases of HIV were detected after Yeztugo treatment. Gilead did not say the size of the patient population in these trials. Gilead also presented modeling data which suggest that Yeztugo, when given at a slightly altered dosing regimen, can retain its efficacy in patients with tuberculosis, who often take other medications that can otherwise interfere with PrEP’s overall activity. Yeztugo is currently only approved in the U.S., but Gilead is working on securing regulatory clearances around the world, including South Africa. The pharma last week signed an agreement with the Global Fund to provide the HIV prophylactic to low- and middle-income countries at the same time as in high-income countries. A spokesperson at the time declined to disclose specific pricing details for Yeztugo under the Global Fund partnership, but told BioSpace that it will provide the product to the program at no profit to Gilead. ViiV Finds Patients ‘Happy’ to Switch to Apretude from Daily Oral PrEP ViiV unveiled data from the PILLAR and EBONI implementation trials showing that the use of Apretude, a long acting PrEP given every other month, is both acceptable and feasible for patients across different demographic groups, including transgender men, Black women and men who have sex with men (MSM). Apretude was the first injectable long acting HIV PrEP, approved in the US in 2021 . Viiv is a joint venture between GSK, Pfizer and Shionogi that is focued on HIV care. EBONI, which focused on Black cis- and transgender women, found Apretude to be “highly appropriate” and “feasible” for the prevention of HIV in this population, as per Monday’s release. PILLAR, meanwhile, enrolled MSM and transgender men, among whom 95% reported being “happy” with switching from oral PrEP medications to Apretude. ViiV additionally presented data from several real-world studies, showing that the combination of cabotegravir and rilpivirine—marketed as the injectable drug Cabenuva in the U.S.—not only sustains viral suppression in patients but also improves their overall experience. For instance, results in the Phase IIIb VOLITION study showed that 89% of patients with HIV who had reached viral suppression chose to switch to Cabenuva from oral daily pills. Largely, patients opted for Cabenuva so they wouldn’t have to worry about missing a dose and so they wouldn’t have to bring their medication all the time. Cabenuva can be dosed monthly or every two months, according to its label . Meanwhile, results from the two-year prospective observational study BEYOND found that of 308 patients who decided to switch to Cabenuva, 97% were able to maintain viral suppression at 24 months. Merck Pushes Monthly PrEP Pill to Phase III Merck announced on Monday that it will launch the Phase III EXPrESSIVE program to study MK-8527, a once-monthly and orally available nucleoside reverse transcriptase translocation inhibitor to prevent HIV infection. The program will include EXPrESSIVE-11, which will test the PrEP candidate in more than 8,500 high-risk participants across 16 countries. That trial is set to start enrolling in August. Meanwhile, the EXPrESSIVE-10 study will focus on women and adolescents in sub-Saharan Africa and is set to start recruiting “in the next few months,” as per Monday’s release. Phase II data for MK-8527, which will be presented at IAS 2025 on Wednesday, is supporting the advancement of the drug into late-stage development, according to Merck, with encouraging pharmacokinetic and safety findings. 350 people with low risk of HIV-1 exposure participated in the mid-stage study. The EXPrESSIVE program represents Merck’s comeback in the late-stage PrEP arena after discontinuing the prophylaxis program for oral islatravir in September 2022, after safety concerns led the company to suspend dosing in a Phase II study in November 2021. Like MK-8527, the pharma was proposing islatravir as a once-monthly oral option to prevent HIV infection. However, Merck continued to assess islatravir as a therapeutic option for patients with HIV in combination with another HIV drug called doravirine. The FDA last week accepted a new drug application for this combo regimen for adults with virologically suppressed HIV-1.