Komatsu, Takashi
https://orcid.org/0000-0002-7161-1744
Mayo Clinic
United States Food and Drug Administration
Citations 2
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
Ljungman, Per , Chemaly, Roy F. , Khawaya, Fareed, Badshah, Cyrus, Boeckh, Michael, Fournier, Martha , Hodowanec, Aimee , Komatsu, Takashi , Manuel, Oriol , Pikis, Andreas, Westman, Gabriel , Griffiths, Paul , Kotton, Camille N. , Forum, for the CMV Definitions Working Group of the Transplant Associated Virus Infections, Komatsu, Takashi, Piki, Andreas, Westman, Gabriel, Caliendo, Angie, Chou, Sunwen, Humar, Atul , Wong, Michelle , Wolf, Dana G. , Razonable, Raymund R , Alain, Sophie , Avery, Robin K , Boeckh, Michael , Limaye, Ajit P. , Natori, Yoichiro , Navarro, David , Razonable, Raymund R. , Miller, Veronica , Forum, for the CMV Definitions Working Group of the Transplant Associated Virus Infections, Komatsu, Takashi, Westman, Gabriel, Randhawa, Parmjeet Singh , Slavin, Monica A. , Wong, Michelle
Clinical Infectious Diseases | June 20, 2024 | Volume: 79 | Issue: 3 | Pages: 787-794
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.
Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials
Chemaly, Roy F. , Chou, Sunwen, Einsele, Hermann, Griffiths, Paul , Mullane, Kathleen M. , Kotton, Camille N. , Lundgren, Jens , Komatsu, Takashi , Lischka, Peter, Josephson, Filip, Douglas, Cameron, Umeh, Obi, Forum, Resistant Definitions Working Group of the Cytomegalovirus Drug Development, Lundgren, Jens , Avery, Robin K , Razonable, Raymund R. , Miller, Veronica , Ljungman, Per , Forum, Resistant Definitions Working Group of the Cytomegalovirus Drug Development
Clinical Infectious Diseases | August 17, 2018 | Volume: 68 | Issue: 8 | Pages: 1420-1426
Abstract Despite advances in preventive strategies, cytomegalovirus (CMV) infection remains a major complication in solid organ and hematopoietic cell transplant recipients. CMV infection may fail to respond to commercially available antiviral therapies, with or without demonstrating genotypic mutation(s) known to be associated with resistance to these therapies. This lack of response has been termed “resistant/refractory CMV” and is a key focus of clinical trials of some investigational antiviral agents. To provide consistent criteria for future clinical trials and outcomes research, the CMV Resistance Working Group of the CMV Drug Development Forum (consisting of scientists, clinicians, regulatory officials, and industry representatives from the United States, Canada, and Europe) has undertaken establishing standardized consensus definitions of “resistant” and “refractory” CMV. These definitions have emerged from the Working Group’s review of the available virologic and clinical literature and will be subject to reassessment and modification based on results of future studies.