Valganciclovir Dosing in Pediatric Solid Organ Transplant Recipients
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
Summary
Valganciclovir is extensively used for cytomegalovirus (CMV) infection treatment and
prophylaxis after solid organ transplantation (SOT). VGC dosing is problematic in children.
valganciclovir has variable absorption and is renally excreted. Area Under the Curve (AUC)
(0-24) of 40-60 mcg∙h/L is a predictive pharmacokinetic parameter of efficacy and safety.
Dosing based on manufacturer recommendations is supra-therapeutic in most cases. A few
published dosing algorithms result in AUC out of range.
Objective: To prospectively validate a Valganciclovir administration dosing regimen and
compare it to other dosing algorithms.
Methods: Children after SOT at Schneider Children's Medical Center, the largest tertiary
pediatric center in Israel, were prospectively studied, starting Dec 2014. The dosing regimen
was derived from Seattle Children's Hospital guidelines; 14-16 mg/kg/dose. For impaired renal
function, stratified dose reduction was used. Blood was withdrawn at steady state: 2, 5 and
10 hours post dosing. Drug level was analyzed by high pressure liquid chromatography (HPLC).