Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum
Per Ljungman, Roy F. Chemaly, Fareed Khawaya, Sophie Alain, Robin K. Avery, Cyrus Badshah, Michael Boeckh, Martha Fournier, Aimee Hodowanec, Takashi Komatsu, Ajit P. Limaye, Oriol Manuel, Yoichiro Natori, David Navarro, Andreas Pikis, Raymund R. Razonable, Gabriel Westman, Veronica Miller, Paul Griffiths, Camille N. Kotton, for the CMV Definitions Working Group of the Transplant Associated Virus Infections Forum, Aimee Hodowanec, Takashi Komatsu, Andreas Piki, Gabriel Westman, Angie Caliendo, Sunwen Chou, Atul Humar, Parmjeet Randhawa, Monica A. Slavin, Michelle Wong, Dana G. Wolf
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.