A NEW CENTURY OF PEDIATRIC TRANSPLANTATION?

E. Launay¹, N. Kassir², Y. Théôret², C. Litalien², M. Duval³, F. Alvarez⁴, D. Larocque⁵, A. Lapeyraque⁶, V. Lamarre¹, P. Ovetchkine^1
1Maladies Infectieuses Pédiatriques, CHU Sainte Justine, MONTREAL/CANADA, ²Clinical Pharmacoogy Unit, CHU Sainte Justine, Montreal/QC/CANADA, ³Onco-hematology, CHU Sainte-Justine, Montreal/CANADA, ⁴Hepato-gastroenterology, CHU Sainte-Justine, Montreal/QC/CANADA, ⁵Pharmacy, CHU Sainte-Justine, Montreal/CANADA, ⁶Nephrology, CHU Sainte-Justine, Montreal/CANADA

Body: Introduction: The lack of pediatric pharmacokinetic (PK) data has limited the use of valganciclovir (VGCV) in transplanted children. The objective of this study was to compare the PK profile of oral VGCV in pediatric transplant recipients with an effective IV ganciclovir (GCV) treatment. Methods: According to the pre-emptive strategy used at our institution for transplant recipient, a weekly CMV viremia (by Real Time PCR method) was performed and IV GCV (5 mg/kg/dose every h) started as soon as CMV viremia was detected. IV GCV was switched to oral VGCV when a first negative CMV PCR was obtained. Twenty-four hour area under the concentration-time curve (AUC _0-24) of active ganciclovir was measured during IV GCV when viremia was controlled (individual therapeutic AUC_0-24) and after switching to oral VGCV. Concentration levels were determined by HPLC. Results: Ten transplanted children (7 solid organ and 3 hematopoietic stem cell) with a median age of 5.2 years [0.8-13.1] were included. The results are summarized in the table. No symptomatic CMV disease nor toxicity were observed. The first negative PCR was obtained after a median of 4 days [7-70] after the beginning of IV GCV. Conclusion: These data suggest that VGCV doses smaller that the ones suggested in the literature may be sufficient to achieve exposure similar to that obtained with IV GCV. In pediatrics, VGCV could be use as first line therapy in pre-emptive strategies. Moreover, the great inter-individual variability observed supports the use of drug monitoring particularly in case of treatment failure or serious adverse effects. TABLE: Pharmacokinetic profiles after IV GCV and oral VGCV.

Disclosure: All authors have declared no conflicts of interest.