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Journal Articles Clinical Infectious Diseases Year : 2018

Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis

Yoichiro Natori
  • Function : Author
Ali Alghamdi
  • Function : Author
Mahmood Tazari
  • Function : Author
Ani Orchanian-Cheff
  • Function : Author
Atul Humar
  • Function : Author
Rekha Abichandani
  • Function : Author
Barbara Alexander
  • Function : Author
Robin Avery
  • Function : Author
M Michelle Berrey
  • Function : Author
Debra Birnkrant
  • Function : Author
Emily Blumberg
  • Function : Author
Terry Bowlin
  • Function : Author
Jennifer Brooks
  • Function : Author
Roy Chemaly
  • Function : Author
Gavin Cloherty
  • Function : Author
William Cruikshank
  • Function : Author
Lesia Dropulic
  • Function : Author
Hermann Einsele
  • Function : Author
Jay Erdman
  • Function : Author
Gary Fahle
  • Function : Author
Lynn Fallon
  • Function : Author
Heather Gillis
  • Function : Author
Dimitri Gonzalez
  • Function : Author
Kurt Gunter
  • Function : Author
Hans Hirsch
  • Function : Author
Aimee Hodowanec
  • Function : Author
Atul Humar
  • Function : Author
Peter Hunt
  • Function : Author
Filip Josephson
  • Function : Author
Camille Kotton
  • Function : Author
Philip Krause
  • Function : Author
Frank Kuhr
  • Function : Author
Christopher Lademacher
  • Function : Author
Randall Lanier
  • Function : Author
Tadd Lazarus
  • Function : Author
John Leake
  • Function : Author
Randi Leavitt
  • Function : Author
Sandra Nusinoff Lehrman
  • Function : Author
Li Li
  • Function : Author
Paula Isabelle Lodding
  • Function : Author
Jens Lundgren
  • Function : Author
Howard Mayer
  • Function : Author
Megan Mccutcheon
  • Function : Author
John Mckinnon
  • Function : Author
Thomas Mertens
  • Function : Author
Veronica Miller
  • Function : Author
Kevin Modarress
  • Function : Author
Johann Mols
  • Function : Author
Sally Mossman
  • Function : Author
Yoshihiko Murata
  • Function : Author
David Murawski
  • Function : Author
Jeffrey Murray
  • Function : Author
Yoichiro Natori
  • Function : Author
Garrett Nichols
  • Function : Author
Jules O’rear
  • Function : Author
Karl Peggs
  • Function : Author
Andreas Pikis
  • Function : Author
Mark Prichard
  • Function : Author
Raymund Razonable
  • Function : Author
Marcie Riches
  • Function : Author
Jeff Roberts
  • Function : Author
Wael Saber
  • Function : Author
Chalom Sayada
  • Function : Author
Mary Singer
  • Function : Author
Thomas Stamminger
  • Function : Author
Anna Wijatyk
  • Function : Author
Dong Yu
  • Function : Author
Bernhardt Zeiher
  • Function : Author

Abstract

Symptomatic cytomegalovirus (CMV) disease has been the standard endpoint for clinical trials in organ transplant recipients. Viral load may be a more relevant endpoint due to low frequency of disease. We performed a meta-analysis and systematic review of the literature. We found several lines of evidence to support the validity of viral load as an appropriate surrogate end-point, including the following: (1) viral loads in CMV disease are significantly greater than in asymptomatic viremia (odds ratio, 9.3 95% confidence interval, 4.6-19.3); (2) kinetics of viral replication are strongly associated with progression to disease; (3) pooled incidence of CMV viremia and disease is significantly lower during prophylaxis compared with the full patient follow-up period (viremia incidence: 3.2% vs 34.3%; P < .001) (disease incidence: 1.1% vs 13.0%; P < .001); (4) treatment of viremia prevented disease; and (5) viral load decline correlated with symptom resolution. Based on the analysis, we conclude that CMV load is an appropriate surrogate endpoint for CMV trials in organ transplant recipients.
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Dates and versions

hal-03942946 , version 1 (06-02-2023)

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Yoichiro Natori, Ali Alghamdi, Mahmood Tazari, Veronica Miller, Shahid Husain, et al.. Use of Viral Load as a Surrogate Marker in Clinical Studies of Cytomegalovirus in Solid Organ Transplantation: A Systematic Review and Meta-analysis. Clinical Infectious Diseases, 2018, 66 (4), pp.617-631. ⟨10.1093/cid/cix793⟩. ⟨hal-03942946⟩
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