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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 1420-1426 |
| Number of pages | 7 |
| Journal | Clinical Infectious Diseases |
| Volume | 68 |
| Issue number | 8 |
| DOIs | |
| State | Published - Apr 8 2019 |
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Keywords
- clinical trials
- cytomegalovirus
- definitions
- refractory
- resistance
ASJC Scopus subject areas
- Microbiology (medical)
- Infectious Diseases
Cite this
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; Avery, Robin; Razonable, Raymund R.; Mullane, Kathleen M.; Kotton, Camille; Lundgren, Jens; Komatsu, Takashi E.; Lischka, Peter; Josephson, Filip; Douglas, Cameron M.; Umeh, Obi; Miller, Veronica; Ljungman, Per.
In: Clinical Infectious Diseases, Vol. 68, No. 8, 08.04.2019, p. 1420-1426.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Definitions of resistant and refractory cytomegalovirus infection and disease in transplant recipients for use in clinical trials
AU - Chemaly, Roy F.
AU - Chou, Sunwen
AU - Einsele, Hermann
AU - Griffiths, Paul
AU - Avery, Robin
AU - Razonable, Raymund R.
AU - Mullane, Kathleen M.
AU - Kotton, Camille
AU - Lundgren, Jens
AU - Komatsu, Takashi E.
AU - Lischka, Peter
AU - Josephson, Filip
AU - Douglas, Cameron M.
AU - Umeh, Obi
AU - Miller, Veronica
AU - Ljungman, Per
PY - 2019/4/8
Y1 - 2019/4/8
N2 - 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.
AB - 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.
KW - clinical trials
KW - cytomegalovirus
KW - definitions
KW - refractory
KW - resistance
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U2 - 10.1093/cid/ciy696
DO - 10.1093/cid/ciy696
M3 - Article
VL - 68
SP - 1420
EP - 1426
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
SN - 1058-4838
IS - 8
ER -