Valganciclovir for the treatment of cytomegalovirus infections in pediatric intestinal transplant recipients: A case series

Background: Cytomegalovirus (CMV) is the most common opportunistic infection post-transplant and is associated with significant morbidity and mortality. Currently, there are no FDA dosing recommendations for the use of valganciclovir for the treatment of CMV infections in pediatric patients. This case series describes the use of valganciclovir for the treatment of CMV infections in nine pediatric intestinal transplant recipients (pITR). Methods: Retrospective review of pITR between January 2004 and December 2016. The primary outcome was resolution of CMV viremia. Secondary outcomes included time-to-resolution of viremia, relapse rate, incidence of resistance, hematologic adverse effects, rejection, graft loss, and death. Results: Of 214 pITR, ten CMV infections were treated with valganciclovir. One patient was lost to follow-up while on treatment and was not included. Eight (89%) patients had resolution of CMV viremia. The average dose of valganciclovir was 14.3mg/kg (SD 0.82) twice daily. CMV resistance testing was completed in three (33.3%) patients; one patient had a documented mutation requiring leflunomide to clear viremia. Three (33.3%) patients experienced rejection within one month prior to or during treatment for CMV. Six (66.6%) experienced hematologic side effects. No patients died or experienced graft loss. Conclusion: This is the first study to assess the use of valganciclovir for the treatment of CMV in pITR. Based on these results, weight-based dosing of valganciclovir seems to be an appropriate option for the treatment of CMV in pITR. Given limited number of patients reviewed in this case series and the high incidence of hematologic side effects, further investigation is warranted.