Monitoring HCMV Infection With Quantitative Real-Time PCR in HCMV-Positive Orthotopic Liver Transplant Recipients, and Predictive Factors for Treatment of the First Episode of HCMV Viremia

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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Specimen Requirements: Selection, Collection, Transport, and Processing

Grys¹,

Smith²

2009

Clinical Virology Manual

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Monitoring HCMV Infection With Quantitative Real-Time PCR in HCMV-Positive Orthotopic Liver Transplant Recipients, and Predictive Factors for Treatment of the First Episode of HCMV Viremia

Cited by 4 publications

References 12 publications

Comparaison de la trousse LightCycler® CMV Quant Kit (Roche Diagnostics) avec une PCR « maison » standardisée pour la quantification du CMV sur sang total

Comparaison de la trousse LightCycler® CMV Quant Kit (Roche Diagnostics) avec une PCR « maison » standardisée pour la quantification du CMV sur sang total

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

Specimen Requirements: Selection, Collection, Transport, and Processing

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