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Clin Infect Dis. 2019 Apr 8;68(8):1420-1426. doi: 10.1093/cid/ciy696.

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

Author information

1
Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center, Houston.
2
Division of Infectious Diseases, Oregon Health and Science University, and Research and Development Service, Veterans Affairs Portland Health Care System.
3
Department of Internal Medicine II, University Hospital Wuerzburg, Germany.
4
Institute for Immunity and Transplantation, University College London Medical School, United Kingdom.
5
Division of Infectious Diseases, Department of Medicine, Johns Hopkins University, Baltimore, Maryland.
6
Division of Infectious Diseases, Department of Medicine, William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic, Rochester, Minnesota.
7
Section of Infectious Diseases and Global Health, Department of Medicine, University of Chicago, Illinois.
8
Infectious Diseases Division, Massachusetts General Hospital, Harvard Medical School, Boston.
9
Centre for Health and Infectious Disease Research, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Denmark.
10
Division of Antiviral Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
11
AiCuris Anti-infective Cures GmbH, Wuppertal, Germany.
12
Swedish Medical Products Agency, Uppsala.
13
Merck & Co, Inc, Kenilworth, New Jersey.
14
Shire Global Clinical Development (Immunology Therapeutic Area), Lexington, Massachusetts.
15
Forum for Collaborative Research, University of California, Berkeley.
16
Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital.
17
Division of Hematology, Department of Medicine, Huddinge, Karolinska Institutet, Stockholm, Sweden.

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.

KEYWORDS:

clinical trials; cytomegalovirus; definitions; refractory; resistance

PMID:
30137245
DOI:
10.1093/cid/ciy696

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