Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials.

@article{Ljungman2017DefinitionsOC,
  title={Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials.},
  author={Per Ljungman and Michael J Boeckh and Hans H. Hirsch and Filip Josephson and Jens D. Lundgren and Garrett Nichols and Andreas Pikis and Raymund R. Razonable and Veronica Miller and Paul D. Griffiths},
  journal={Clinical infectious diseases : an official publication of the Infectious Diseases Society of America},
  year={2017},
  volume={64 1},
  pages={
          87-91
        }
}
  • P. Ljungman, M. Boeckh, +7 authors P. Griffiths
  • Published 2017
  • Medicine, Biology
  • Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
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 2002. Since then, there have been major developments in its diagnosis and management. Therefore, the CMV Drug Development Forum consisting of scientists, clinicians, regulators, and industry representatives… 
Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials.
  • R. Chemaly, S. Chou, +13 authors P. Ljungman
  • Medicine, Biology
    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
  • 2019
TLDR
The CMV Resistance Working Group of the CMV Drug Development Forum has undertaken establishing standardized consensus definitions of "resistant" and "refractory" CMV, which have emerged from the available virologic and clinical literature.
Update on cytomegalovirus in transplant recipients: new agents, prophylaxis, and cell-mediated immunity.
TLDR
The past 1-2 years have seen major developments in the area of CMV management in transplant recipients, and expanding diagnostic and therapeutic capabilities provide a foundation for optimizing strategies in the future, to reduce morbidity and mortality from CMV.
Optimizing the management of cytomegalovirus infection in transplant patients
TLDR
Cytomegalovirus was a major topic for discussion, since it remains an important cause of morbidity and mortality in transplant recipients and in the future, novel diagnostic technologies and new antiviral drugs may help to reduce the risk of post-transplant cytomegalvirus infection and disease.
Clinical Diagnostic Testing for Human Cytomegalovirus Infections.
TLDR
The issues, limitations, and application of diagnostic strategies for transplant recipients and congenital infection are summarized, including examples of screening programs for congenital HCMV that have been implemented at several centers in Japan, Italy, and the United States.
Human Cytomegalovirus Prophylaxis and Treatment in Lung Transplantation in the Current Era
  • K. Mullane
  • Medicine, Biology
    Current Pulmonology Reports
  • 2020
TLDR
In the past 15 years major advances in diagnosis, prevention, management and risk evaluation in patients with HCMV have occurred, and research continues, which will impact outcomes in the transplant population.
The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation
TLDR
Highlights include advances in molecular and immunologic diagnostics, improved understanding of diagnostic thresholds, optimized methods of prevention, advances in the use of novel antiviral therapies and certain immunosuppressive agents, and more savvy approaches to treatment resistant/refractory disease.
A Practical Review of Cytomegalovirus in Gastroenterology and Hepatology
TLDR
This review will focus on the pathophysiology, diagnosis, and management of CMV in patient populations relevant to the practice of gastroenterology and hepatology—liver transplant recipients, inflammatory bowel disease patients, and otherwise immunocompetent patients.
Pathogenesis of human cytomegalovirus in the immunocompromised host
Human cytomegalovirus (HCMV) is a herpesvirus that infects ~60% of adults in developed countries and more than 90% in developing countries. Usually, it is controlled by a vigorous immune response so
Challenges and Clinical Implications of the Diagnosis of Cytomegalovirus Lung Infection in Children
TLDR
Lung CMV infections in children are more prevalent in immunocompromised hosts and premature newborns, and should prompt further investigation into conditions altering immune mechanisms usually in place to containCMV infections.
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This study seeks to update the definitions of CMV on the basis of recent developments in diagnostic techniques, as well as to add to these definitions the concept of indirect effects caused by CMV.
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Significant factors in multivariate analysis for the reduction of death from CMV disease were acute graft-versus-host disease and pre-emptive therapy based on rapid diagnosis with polymerase chain reaction.
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Treatment with oral CMX001 at a dose of 100 mg twice weekly significantly reduced the incidence of CMV events in recipients of hematopoietic-cell transplants.
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TLDR
Letermovir was effective in reducing the incidence of CMV infection in recipients of allogeneic hematopoietic-cell transplants, with no indication of hematologic toxicity or nephrotoxicity.
The Efficacy and Safety of 200 Days Valganciclovir Cytomegalovirus Prophylaxis in High‐Risk Kidney Transplant Recipients
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  • Medicine
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TLDR
It is demonstrated that extending valganciclovir prophylaxis (900 mg once daily) to 200 days significantly reduces the incidence of CMV disease and viremia through to 12 months compared with 100 days’ prophYLaxis, without significant additional safety concerns associated with longer treatment.
Commutability of the First World Health Organization International Standard for Human Cytomegalovirus
TLDR
The lack of commutability seen when using the WHO standard with several of the assays here suggests that further work is needed to bring us toward true consensus, and may require a multifaceted approach.
A Randomized, Controlled Trial of Prophylactic Ganciclovir for Cytomegalovirus Pulmonary Infection in Recipients of Allogeneic Bone Marrow Transplants
TLDR
A controlled trial of ganciclovir in recipients of bone marrow transplants who had asymptomatic pulmonary CMV infection and sought to identify risk factors for the development of CMV interstitial pneumonia.
Are We There Yet? Impact of the First International Standard for Cytomegalovirus DNA on the Harmonization of Results Reported on Plasma Samples.
TLDR
The variability in CMV DNA results reported on individual samples has been reduced by the IS, but ongoing clinically relevant variability persists, preventing meaningful interassay result comparison.
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