title: Clinical utility of cytomegalovirus viral load testing for predicting CMV disease in D+/R- solid organ transplant recipients.
abstract: Despite prophylaxis, cytomegalovirus (CMV) disease is common in donor seropositive (D+)/recipient seronegative (R-) transplant patients after cessation of prophylaxis. Early detection of CMV may allow for pre-emptive therapy to prevent active disease. The clinical utility of quantitative plasma viral load measurements for predicting CMV disease was determined in 364 D+/R- organ transplant patients receiving prophylaxis (100 d of valganciclovir or oral ganciclovir). Measurements were performed every 2 weeks until day 100 and at months 4, 4.5, 5, 6, 8 and 12 post-transplant. CMV disease occurred in 64 (17.6%) patients by 12 months. Using a positive cut-off value of >400 copies/mL, sensitivity was 38%, specificity 60%, positive predictive value 17%, and negative predictive value 82% for prediction of CMV disease. Therefore, routine monitoring would have predicted disease in only 24/64 (38%) patients. The test characteristics were not improved by changing the viral load cut-off point for defining a positive result. Similarly, single time point measures at the end of prophylaxis or month 4 had low sensitivity for disease prediction. Overall, regular CMV plasma viral load measurements were only of modest value in predicting CMV disease.
authors.affiliation: University Health Network, Toronto General Hospital, Toronto ON, Canada. Atul.Humar@uhn.on.ca
authors.forename: Atul
authors.initials: A
authors.lastname: Humar
authors.forename: Carlos
authors.initials: C
authors.lastname: Paya
authors.forename: Mark D
authors.initials: MD
authors.lastname: Pescovitz
authors.forename: Ed
authors.initials: E
authors.lastname: Dominguez
authors.forename: Kenneth
authors.initials: K
authors.lastname: Washburn
authors.forename: Emily
authors.initials: E
authors.lastname: Blumberg
authors.forename: Barbara
authors.initials: B
authors.lastname: Alexander
authors.forename: Richard
authors.initials: R
authors.lastname: Freeman
authors.forename: Nigel
authors.initials: N
authors.lastname: Heaton
authors.forename: Barbara
authors.initials: B
authors.lastname: Mueller
mesh_terms: D000284:Administration, Oral; D000998:Antiviral Agents / Q000494:pharmacology / Q000627:therapeutic use; D003587:Cytomegalovirus / Q000378:metabolism*; D003586:Cytomegalovirus Infections / Q000175:diagnosis*; D004311:Double-Blind Method; D015774:Ganciclovir / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D016377:Organ Transplantation / Q000009:adverse effects / Q000379:methods*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D013997:Time Factors; D016896:Treatment Outcome; D000077562:Valganciclovir; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D000077562:Valganciclovir; D015774:Ganciclovir