Abstract:
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.
摘要:
巨细胞病毒(CMV)感染和疾病是移植受体发病和死亡的重要原因。为了在临床试验中开发CMV结局的一致报告,制定了CMV感染和疾病的定义,最近一次于2017年发表。从那以后,有了重大发展,包括新的抗病毒药物的注册。因此,移植相关病毒感染论坛,由科学家组成,临床医生,监管者,和行业代表,已经产生了这些定义的更新版本,结合了最近的知识,目的是支持临床研究和药物开发。这还包括有关先前于2019年发布的耐药性和难治性CMV感染定义的更新。随着田野的发展,这些定义的更新的需要是明确的,和临床医生之间的合作努力,科学家,监管者,行业代表可以为这项工作提供平台。