Definitions of resistant and refractory cytomegalovirus infection and disease in transplant recipients for use in clinical trials

Chemaly RF, Chou S, Einsele H, Griffiths P, Avery R, Razonable RR, Mullane KM, Kotton C, Lundgren J, Komatsu TE, Lischka P, Josephson F, Douglas CM, Umeh O, Miller V, Ljungman P (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Book Volume: 68

Pages Range: 1420-1426

Journal Issue: 8

DOI: 10.1093/cid/ciy696

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.

Involved external institutions

Mayo Clinic United States (USA) (US) Harvard University United States (USA) (US) University of Copenhagen Denmark (DK) AiCuris GmbH & Co. KG Germany (DE) Merck & Co., Inc. / Merck Sharp & Dohme Corp (MSD) United States (USA) (US) University of California, Berkeley United States (USA) (US) University of Texas MD Anderson Cancer Center United States (USA) (US) Universitätsklinikum Würzburg Germany (DE) University College London (UCL) United Kingdom (GB) Johns Hopkins University (JHU) United States (USA) (US) University of Chicago United States (USA) (US) Food and Drug Administration (FDA / USFDA) United States (USA) (US) Medical Products Agency (MPA) / Läkemedelsverket Sweden (SE) Karolinska University Hospital / Karolinska Universitetssjukhuset Sweden (SE) Oregon Health and Science University (OSHU) United States (USA) (US)

How to cite

APA:

Chemaly, R.F., Chou, S., Einsele, H., Griffiths, P., Avery, R., Razonable, R.R.,... Ljungman, P. (2019). Definitions of resistant and refractory cytomegalovirus infection and disease in transplant recipients for use in clinical trials. Clinical Infectious Diseases, 68(8), 1420-1426. https://doi.org/10.1093/cid/ciy696

MLA:

Chemaly, Roy F., et al. "Definitions of resistant and refractory cytomegalovirus infection and disease in transplant recipients for use in clinical trials." Clinical Infectious Diseases 68.8 (2019): 1420-1426.

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