Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center, Stockholm, Sweden.
Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden.
Clin Infect Dis. 2024 Sep 26;79(3):787-794. doi: 10.1093/cid/ciae321.
Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2017. Since then, there have been major developments, including registration of new antiviral agents. Therefore, the Transplant Associated Virus Infections Forum, which consists of scientists, clinicians, regulators, and industry representatives, has produced an updated version of these definitions that incorporates recent knowledge with the aim of supporting clinical research and drug development. This also includes an update regarding the definition of resistant and refractory CMV infections previously published in 2019. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts among clinicians, scientists, regulators, and industry representatives can provide a platform for this work.
巨细胞病毒（CMV）感染和疾病是移植受者发病率和死亡率的重要原因。为了在临床试验中对 CMV 结果进行一致的报告，制定了 CMV 感染和疾病的定义，并于最近在 2017 年发表。此后，出现了包括新抗病毒药物注册在内的重大进展。因此，由科学家、临床医生、监管机构和行业代表组成的移植相关病毒感染论坛，制作了这些定义的更新版本，其中纳入了最新的知识，旨在支持临床研究和药物开发。这还包括对 2019 年发表的先前关于耐药和难治性 CMV 感染的定义的更新。随着该领域的发展，明确需要对这些定义进行更新，临床医生、科学家、监管机构和行业代表之间的合作努力可以为这项工作提供平台。
