Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum

Author:

Ljungman Per12ORCID,Chemaly Roy F3,Khawaya Fareed3,Alain Sophie4,Avery Robin5,Badshah Cyrus6,Boeckh Michael78,Fournier Martha9,Hodowanec Aimee10,Komatsu Takashi10,Limaye Ajit P11,Manuel Oriol12,Natori Yoichiro13,Navarro David1415,Pikis Andreas10,Razonable Raymund R1617ORCID,Westman Gabriel1819,Miller Veronica20,Griffiths Paul D21,Kotton Camille N22,Hodowanec Aimee,Komatsu Takashi,Piki Andreas,Westman Gabriel,Caliendo Angie,Chou Sunwen,Humar Atul,Randhawa Parmjeet,Slavin Monica,Wong Michelle,Wolf Dana,

Affiliation:

1. Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center , Stockholm , Sweden

2. Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet , Stockholm , Sweden

3. Department of Infectious Diseases, Infection Control, and Employee Health, University of Texas MD Anderson Cancer Center , Houston, Texas , USA

4. Laboratoire de Bactériologie-Virologie-Hygiène, French National Reference Center for Herpesviruses, CHU Limoges , Limoges , France

5. Division of Infectious Diseases, Johns Hopkins , Baltimore, Maryland , USA

6. Merck & Co, Inc. , Rahway, New Jersey , USA

7. Vaccine and Infectious Disease and Clinical Research Division, Fred Hutchinson Cancer Research Center , Seattle, Washington , USA

8. Department of Medicine, University of Washington , Seattle, Washington , USA

9. Takeda Pharmaceuticals Inc. , Cambridge, Massachusetts , USA

10. Division of Antivirals, Center for Drug Evaluation and Research, US Food and Drug Administration , Silver Spring, Maryland , USA

11. Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington , Seattle, Washington , USA

12. Infectious Diseases Service and Transplantation Center, Lausanne University Hospital and University of Lausanne , Lausanne , Switzerland

13. Division of Infectious Diseases, Miami Transplant Institute, Jackson Health System, University of Miami Miller School of Medicine , Miami, Florida , USA

14. Microbiology Service, Clinic University Hospital, INCLIVA Biomedical Research Institute, Department of Microbiology, School of Medicine, University of Valencia , Valencia , Spain

15. Centro de Investigación Biomédica en Red Enfermedades Infecciosas , Valencia , Spain

16. Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Medicine, Mayo Clinic , Rochester, Minnesota , USA

17. William J. von Liebig Center for Transplantation and Clinical Regeneration, Mayo Clinic , Rochester, Minnesota , USA

18. Swedish Medical Products Agency , Uppsala , Sweden

19. Department of Medical Sciences, Section of Infectious Diseases, Uppsala University , Uppsala , Sweden

20. Forum for Collaborative Research, University of California , Berkeley, California , USA

21. Institute for Immunity and Transplantation, University College London Medical School , London , United Kingdom

22. Transplant and Immunocompromised Host Infectious Diseases Infectious Diseases Division, Massachusetts General Hospital, Harvard Medical School , Boston, Massachusetts , USA

Abstract

Abstract Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2017. Since then, there have been major developments, including registration of new antiviral agents. Therefore, the Transplant Associated Virus Infections Forum, which consists of scientists, clinicians, regulators, and industry representatives, has produced an updated version of these definitions that incorporates recent knowledge with the aim of supporting clinical research and drug development. This also includes an update regarding the definition of resistant and refractory CMV infections previously published in 2019. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts among clinicians, scientists, regulators, and industry representatives can provide a platform for this work.

Funder

Forum

AiCuris

AlloVir

Evrys Bio

HHV-6 Foundation

Merck

Takeda

Symbio

Qiagen

Vera Therapeutics

Eurofins Viracor

Publisher

Oxford University Press (OUP)

Reference39 articles.

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