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

Clin Infect Dis. 2024 Sep 26;79(3):787-794. doi: 10.1093/cid/ciae321.

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.

Keywords: CMV; clinical trials; disease definitions; organ transplantation; stem cell transplantation.

MeSH terms

  • Antiviral Agents* / therapeutic use
  • Clinical Trials as Topic*
  • Consensus*
  • Cytomegalovirus Infections* / diagnosis
  • Cytomegalovirus Infections* / drug therapy
  • Cytomegalovirus Infections* / virology
  • Cytomegalovirus* / drug effects
  • Drug Resistance, Viral
  • Humans
  • Organ Transplantation / adverse effects
  • Transplant Recipients*

Substances

  • Antiviral Agents