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Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials

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DOI

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  • Roy F Chemaly
  • Sunwen Chou
  • Hermann Einsele
  • Paul Griffiths
  • Robin Avery
  • Raymund R Razonable
  • Kathleen M Mullane
  • Camille Kotton
  • Jens Lundgren
  • Takashi E Komatsu
  • Peter Lischka
  • Filip Josephson
  • Cameron M Douglas
  • Obi Umeh
  • Veronica Miller
  • Per Ljungman
  • Resistant Definitions Working Group of the Cytomegalovirus Drug Development Forum
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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.

Original languageEnglish
JournalClinical infectious diseases : an official publication of the Infectious Diseases Society of America
Volume68
Issue number8
Pages (from-to)1420-1426
Number of pages7
ISSN1058-4838
DOIs
Publication statusPublished - 8 Apr 2019

Bibliographical note

© The Author(s) 2018. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

    Research areas

  • clinical trials, cytomegalovirus, definitions, refractory, resistance

ID: 55142566