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

被引：150

作者：

Chemaly, Roy F. ^{[1
]}

Chou, Sunwen ^{[2
,3
]}

Einsele, Hermann ^{[4
]}

Griffiths, Paul ^{[5
]}

Avery, Robin ^{[6
]}

Razonable, Raymund R. ^{[7
]}

Mullane, Kathleen M. ^{[8
]}

Kotton, Camille ^{[9
]}

Lundgren, Jens ^{[10
]}

Komatsu, Takashi E. ^{[11
]}

Lischka, Peter ^{[12
]}

Josephson, Filip ^{[13
]}

Douglas, Cameron M. ^{[14
]}

Umeh, Obi ^{[15
]}

Miller, Veronica ^{[16
]}

Ljungman, Per ^{[17
,18
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Infect Dis Infect Control & Employee Hlth, Unit 402,1515 Holcombe Blvd, Houston, TX 77030 USA

[2] Oregon Hlth & Sci Univ, Div Infect Dis, Portland, OR 97201 USA

[3] Vet Affairs Portland Hlth Care Syst, Res & Dev Serv, Portland, OR USA

[4] Univ Hosp Wuerzburg, Dept Internal Med 2, Wurzburg, Germany

[5] UCL, Sch Med, Inst Immun & Transplantat, London, England

[6] Johns Hopkins Univ, Dept Med, Div Infect Dis, Baltimore, MD USA

[7] Mayo Clin, Div Infect Dis, Dept Med, William J von Liebig Ctr Transplantat & Clin Rege, Rochester, MN USA

[8] Univ Chicago, Dept Med, Sect Infect Dis & Global Hlth, Chicago, IL USA

[9] Harvard Med Sch, Massachusetts Gen Hosp, Infect Dis Div, Boston, MA USA

[10] Univ Copenhagen, Rigshosp, Dept Infect Dis, Ctr Hlth & Infect Dis Res, Copenhagen, Denmark

[11] US FDA, Div Antiviral Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[12] AiCuris Antiinfect Cures GmbH, Wuppertal, Germany

[13] Swedish Med Prod Agcy, Uppsala, Sweden

[14] Merck & Co Inc, Kenilworth, NJ USA

[15] Shire Global Clin Dev, Immunol Therapeut Area, Lexington, MA USA

[16] Univ Calif Berkeley, Forum Collaborat Res, Berkeley, CA 94720 USA

[17] Karolinska Univ Hosp, Dept Cellular Therapy & Allogene Stem Cell Transp, Stockholm, Sweden

[18] Karolinska Inst, Dept Med, Div Hematol, Stockholm, Sweden

来源：

CLINICAL INFECTIOUS DISEASES | 2019年 / 68卷 / 08期

关键词：

cytomegalovirus; resistance; refractory; definitions; clinical trials; ANTIVIRAL DRUG-RESISTANCE; GANCICLOVIR-RESISTANT; MUTATIONS; EMERGENCE; OUTCOMES; SUBPOPULATIONS; FOSCARNET; MUTANTS; DNA;

D O I：

10.1093/cid/ciy696

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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.

引用

页码：1420 / 1426

页数：7