Alimatravir

Multi-faceted strategy aims to enable rapid, broad and sustainable access to alimatravir (MK-8527), if approved, in low- and middle-income countries Voluntary licensing agreements cover 129 countries in regions which account for the substantial majority of new HIV diagnoses globally As Phase 3 trials continue, Merck is committed to advancing access plans, working in close collaboration with the HIV community and global health stakeholders Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced early components of a multi-faceted strategy to provide rapid, broad and sustainable access in low- and middle-income countries (LMICs) to alimatravir (MK-8527), an investigational, novel, once-monthly oral pill as pre-exposure prophylaxis (PrEP) for the prevention of HIV-1, following regulatory approval. Initial access plans as part of Merck’s broader strategy include establishing early generic licensing covering 129 LMICs; supporting targeted, regional manufacturing capabilities in Africa and Latin America; and investing early in product manufacturing to enable timely access and availability in regions of high unmet need. The first steps of this strategy are being announced in the lead up to the 26th International AIDS Conference in Rio de Janeiro, Brazil. Planning early for rapid, broad and sustainable access in LMICs: By initiating a multi-faceted access strategy while Phase 3 trials are ongoing and before enrollment is complete, Merck aims to make alimatravir available in LMICs as broadly and as quickly as possible, if approved. Community-guided access strategy: Merck’s access plans have been shaped by years of engagement with the HIV community, advocates and global health stakeholders, and that collaboration will continue as Phase 3 trials progress. A potential new oral PrEP option: If approved, alimatravir would provide an important new option, with the potential to offer one month of protection from HIV-1 in one pill, predicted to be protective starting within one hour after dosing. Globally, 1.2 million people acquired HIV in 2025, approximately 3,300 each day. Today, multiple HIV prevention options are available, including daily oral PrEP, long-acting injectable PrEP, and other evidence-based prevention tools. Yet, according to the 2024 UNAIDS report, only 3.5 million people were using oral PrEP in 2023, demonstrating the urgent need to expand access and uptake to reach the global goal of 20 million people receiving PrEP by 2030. New access programs should enable rapid, broad and sustainable scale-up, and focus on the persistent barriers that may be limiting PrEP use, including stigma and affordability. “Scientific innovation only has impact when it reaches those who need it most,” said Robert M. Davis, chairman and chief executive officer, Merck. “Merck has a deep legacy in HIV and a longstanding commitment to public health. Recognizing the urgent, unmet needs in HIV prevention, we are acting early to enable rapid, broad and sustainable access to alimatravir, an investigational once-monthly oral PrEP option, in low- and middle-income countries. These important first steps reflect years of engagement with advocates and global health stakeholders. As Phase 3 trials progress, we remain committed to advancing our efforts in partnership with the HIV community to help maximize the public health impact of alimatravir, if approved.” Merck has signed seven non-exclusive voluntary licensing agreements* with generic manufacturers, including three in sub-Saharan Africa (Aspen Pharmacare Holdings, Ltd (Aspen), Quality Chemical Industries Limited (Qcil) and UCL Kenya) and four in India (Aurobindo, Cipla, Emcure and Viatris). The royalty-free agreements with these companies cover both the public and private sectors and will enable supply of generic alimatravir in 129 LMICs that account for a substantial majority of new HIV diagnoses globally. Entering into licensing agreements before Phase 3 trial enrollment is complete represents a first in HIV prevention. This early action should help stakeholders across the HIV response begin planning for ambitious scale-up. It will also facilitate the acceleration of developmental and regulatory activities by the licensed generic manufacturers to help them bring generic alimatravir that meets internationally recognized standards to market in licensed territories, if approved. “Merck's early and proactive efforts to enable quick access to its new PrEP option, if approved, are important to help protect the communities most affected by HIV,” said Mark Suzman, chief executive officer of the Gates Foundation, which aims to end or significantly reduce preventable infectious diseases, including HIV, in the next two decades. “We look forward to continuing to work with Merck and other partners who will help advance these plans and expand access to HIV prevention options.” Sustainable access for HIV prevention requires reliable supply chains, strong local partnerships and country ownership and prioritization. The voluntary licensing strategy for alimatravir is designed to help support sustainable access across Africa and other high-burden geographies by enabling regional manufacturing, strengthening supply resilience and supporting long-term availability following approval. Africa has the highest burden of HIV worldwide. With this announcement, for the first time in HIV, generic manufacturers in sub-Saharan Africa have been included in the initial voluntary licenses granted, alongside generic manufacturers in India, enabling planning for introduction and scale-up by local manufacturers. “People across Africa need more options to prevent HIV. A once-monthly pill could provide a different choice for people in how to protect themselves, subject to successful trials and regulatory approval,” said Jean Kaseya, Director General of the Africa Centres for Disease Control and Prevention. “We welcome this decision to engage African manufacturers early. Africa must continue to expand its role across the health innovation value chain, from supporting research ecosystems and clinical trial capacity to manufacturing and access. This is how we strengthen health sovereignty and bring new HIV prevention options closer to our people.” HIV incidence remains a pressing public health challenge in Latin America, and specifically in Brazil, where approximately 55,000 people acquired HIV in 2024. In recognition of this significant unmet need, Merck is in active discussions with organizations, including Fiocruz, with a goal to enable rapid availability and broad supply of alimatravir in the region. To reduce the time between potential regulatory approval of alimatravir and its availability in LMICs, Merck is investing early in its product manufacturing capacity as Phase 3 trials continue. These efforts are intended to help ensure that sufficient product supply is made available, if approved, in areas of high unmet need following the anticipated U.S. approval to enable early program implementation and ambitious scale-up. Merck expects to provide initial supply and continue supplying product as needed while licensed generic manufacturers complete development, obtain the necessary regulatory approvals and prepare to provide supply in the licensed territories. The goal is to help avoid delays in access by providing an initial supply pathway until generic manufacturing capacity is established and brought online. These actions represent important early steps to help support the future availability and supply of alimatravir in countries with a high burden of HIV, subject to applicable regulatory approvals and requirements. Merck is committed to continuing to advance its access plans, working in close collaboration with communities and global health stakeholders, as Phase 3 trials continue. Alimatravir (MK-8527) is being evaluated as a potential once-monthly oral prevention option for HIV-1. Alimatravir inhibits reverse transcriptase through multiple mechanisms, including: inhibition of reverse transcriptase translocation, resulting in immediate chain termination, and induction of structural changes in the viral DNA (delayed chain termination). Alimatravir is currently being evaluated in two ongoing Phase 3 clinical trials. With financial support from the Gates Foundation, the Phase 3 EXPrESSIVE-10 trial (MK-8527-010, NCT07071623) is evaluating the safety and efficacy of alimatravir in adolescent girls and young women in Kenya, South Africa and Uganda. The Phase 3 EXPrESSIVE-11 trial (MK-8527-011, NCT07044297) is evaluating the safety and efficacy of alimatravir among people with greater likelihood of HIV-1 exposure in 16 countries. Both trials are now enrolling. The initiation of the Phase 3 clinical trial program was supported by results of a double-blind, multicenter, Phase 2 trial (MK-8527-007, NCT06045507) examining the safety and pharmacokinetics of alimatravir. The study enrolled 350 participants, 18–65 years of age, with low likelihood of HIV-1 exposure, who were randomized 2:2:2:1 to receive alimatravir (3, 6 or 12 mg) or placebo once monthly for six months. In the trial, the rates of adverse events were similar among those in the alimatravir arms and those in the placebo arm, and no clinically meaningful changes were seen in laboratory tests, including total lymphocyte and CD4 T-cell counts. The pharmacokinetics of alimatravir and alimatravir-triphosphate, the active form of alimatravir, support the continued development of alimatravir as an oral, once-monthly option for PrEP. Merck is committed to ensuring that the people who are participating in the EXPrESSIVE Phase 3 trials have access to alimatravir after the trials conclude, pending regulatory approval. Merck’s Commitment to HIV For more than 40 years, Merck has been committed to research and discovery in HIV leading to scientific breakthroughs that have helped change HIV treatment. Our work has helped pioneer the development of new options across multiple drug classes to help those impacted by HIV. Today, we are developing a series of antiviral options for both HIV treatment and prevention. We’re inspired by the lived experiences of the HIV community as we advance research with real life in mind. Our work focuses on potentially transformative innovations, collaborations with others in the global HIV community and access initiatives to help end the HIV epidemic. At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. The content above comes from the network. if any infringement, please contact us to modify.

全球规模最大的HIV领域国际会议即将开幕。 红枫湾APP： i-base.info网消息，7月26日至30日， 国际艾滋病大会（AIDS 2026） 将在巴西里约热内卢举行。本次会议主题为Rethink·Rebuild·Rise（重新思考、重建、崛起），将围绕 HIV治疗、预防、药物研发及HIV治愈研 究等多个方向展开讨论。 长效HIV治疗研究 AIDS 2026将公布今年早些时候在CROI会议上提出的许多在研药物的最新结果，其中包括： ▶两项 每周口服一次 伊斯拉曲韦/来那帕韦（ISL/LEN）的Ⅲ期临床研究的48周结果——均为最新研究成果。 两种药物分别作用于HIV复制过程中的不同环节，有望通过每周一次服药降低治疗负担。 ▶ 每6个月注射一次 的LEN联合广谱中和抗体（bNAbs）的Ⅱ期研究104周数据。 该组合疗法的两项Ⅲ期研究也已进入公布阶段。如果未来成功，这类方案可能实现——一年仅需少数几次注射，就能维持HIV病毒长期抑制。 ▶ 每4个月注射一次 的广谱中和抗体lotivibart（LVB，N6LS）与长效卡博特韦（CAB-LA）联合用药的情况。 ▶ 每周口服一 次ISL联合ulonivirine（ULO,MK-8507）方案的Ⅱ期研究。 ▶CAB-LA联合长效利匹韦林（RPV-LA）治疗青少年HIV感染者。 红枫湾小编： 从每天口服一次到每周口服一次、每半年注射一次，HIV治疗正在进入“低频给药时代”。 其他重要治疗研究 ▶ ARTISTRY-1/2研究： 公布每日口服比克替拉韦/来那帕韦（BIC/LEN）的最新数据，包括基线耐药情况、长期病毒抑制效果以及不同人群的疗效表现。 ▶ DOR/ISL研究： 公布每日一次多拉韦林/伊斯拉曲韦（DOR/ISL）治疗携带M184V耐药突变患者96周结果，并发布初治及转换治疗Ⅲ期研究的亚组分析。 ▶ VOGUE研究： 直接比较DTG/3TC（多伟托）双药方案与BIC/FTC/TAF（必妥维）三药方案的疗效和安全性。 ▶ BicDol研究： 比较多替拉韦（DTG）与BIC三药方案在高病毒载量感染者中的治疗效果。 ▶ 儿童和青少年治疗： 公布B必妥维在儿童及青少年感染者中的长期随访数据。 红枫湾小编： 从每天吃一把药，到每天只需1粒药；从三药方案到双药方案，HIV治疗正变得越来越简单。 HIV预防研究 ▶数十项关于LEN用于HIV暴露前预防（PrEP）的研究，包括PURPOSE 1/2研究后续随访、美国和非洲真实世界应用情况，以及推广过程中遇到的问题。 ▶数十项关于CAB-LA用于PrEP的研究，包括延迟注射是否影响保护效果、真实世界依从性及药物相互作用等。 ▶长效注射PrEP的实际应用问题，包括LEN和CAB-LA与芬太尼潜在药物相互作用的小鼠研究。 ▶每月口服一次PrEP候选药物MK-8527（现更名为Alimatravir）的药代动力学和耐药性研究；模型分析显示，如实现大规模生产，其成本有望降至每人每年约15美元。 ▶南非女性使用双广谱中和抗体（bNAbs）进行PrEP的随机Ⅱ期临床试验早期结果。 红枫湾小编： HIV预防也正在进入长效时代，但真想用长效PrEP实现终结艾滋病的目标，还需让更多人用得起、用得到。 治愈相关研究 ▶公布两例通过干细胞移植实现HIV长期缓解的新病例，分别来自德国和美国。 研究人员还将分享HIV停药后控制、免疫治疗及病毒持续缓解等最新研究。 ▶其他治愈研究还包括： · CAR-T细胞疗法； · 基因编辑技术； · 广谱中和抗体（bNAbs）治疗。 ▶英国RIO研究将公布利用广谱中和抗体在停用抗病毒治疗后控制病毒反弹的最新数据。 红枫湾小编： 从“终身服药”到“长期缓解”，HIV治愈研究正不断取得突破。不过，距离真正实现人人可及的治愈仍有很长的路要走。未来，科学突破需要与药物可及性同步推进，才能让更多感染者真正受益。