Clinical utility of cytomegalovirus viral load testing for predicting CMV disease in D+/R- solid organ transplant recipients

Am J Transplant. 2004 Apr;4(4):644-9. doi: 10.1111/j.1600-6143.2004.00391.x.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antiviral Agents / pharmacology
  • Antiviral Agents / therapeutic use
  • Cytomegalovirus / metabolism*
  • Cytomegalovirus Infections / diagnosis*
  • Double-Blind Method
  • Ganciclovir / analogs & derivatives*
  • Ganciclovir / therapeutic use
  • Humans
  • Organ Transplantation / adverse effects
  • Organ Transplantation / methods*
  • Polymerase Chain Reaction
  • Sensitivity and Specificity
  • Time Factors
  • Treatment Outcome
  • Valganciclovir
  • Viral Load

Substances

  • Antiviral Agents
  • Valganciclovir
  • Ganciclovir