Valganciclovir has been widely used for cytomegalovirus (CMV) prophylaxis in solid-organ transplant recipients. However, the optimal dosing protocol and target exposure in children are still unclear. Specific data as to the efficacy and safety of low-dose/low-exposure regimens are lacking and urgently needed.
During 2010 to 2015, the clinical efficacy and safety of a weight-based regimen of valganciclovir of 17 mg/kg/day, with a stratified dose reduction for impaired creatinine clearance, given as a CMV prophylaxis for 3 to 6 months, was retrospectively evaluated among pediatric kidney and liver transplant recipients, 12 months posttransplantation. Incidence of CMV infection was assessed by periodic measurements of viral load; adverse events were evaluated.
Eighty-three children who had undergone 86 transplantations and were treated with 17 mg/kg of valganciclovir were included. Median age was 9.77 years (range, 0.6 to 18.9). Twelve (14%) developed CMV infection: 1 during prophylaxis and 11 during follow-up. These events comprised 6 cases of asymptomatic viremia and 6 cases of a clinically significant disease without occurrences of tissue-invasive disease. Treatment-related adverse effects occurred in 7 patients (8%), mostly hematological, resulting in premature drug cessation.
Our results support the use of 17 mg/kg of valganciclovir for CMV prophylaxis in liver and kidney transplanted children as it showed satisfactory long-term efficacy and a good safety profile.
1 Department of Pediatrics C, Schneider Children’s Medical Center of Israel, Petah Tiqva, Israel.
2 Department of Pharmacy, Schneider Children’s Medical Center of Israel, Petah Tiqva, Israel.
3 Clinical Pharmacology and Toxicology Unit, Assaf Harofeh Medical Center, Zriffin, Israel.
4 Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
5 Department of Pediatrics A, Schneider Children’s Medical Center of Israel, Petah Tiqva, Israel.
6 Department of Pediatrics B, Schneider Children’s Medical Center of Israel, Petah Tiqva, Israel.
7 Infectious Diseases Unit, Schneider Children’s Medical Center of Israel, Petah Tiqva, Israel.
Received 27 November 2018. Revision received 25 December 2018.
Accepted 5 January 2019.
The authors declare no funding or conflicts of interest.
A.P., O.P., E.B., E.R., J.A., I.K., H.Y.-B., O.S., and L.A.-H. participated in the performance of the research. A.P., O.P., M.B., and L.A.-H. participated in the data analysis. A.P. and L.A.-H. participated in the writing of the paper. O.P., M.B., E.B., E.R., J.A., I.K., H.Y.-B., and O.S. participated in the critical revision of the manuscript. M.B. and L.A.-H. participated in research design.
Correspondence: Liat Ashkenazi-Hoffnung, MD, Infectious Diseases Unit, Schneider Children’s Medical Center of Israel, 14 Kaplan St, Petah Tiqva 49202, Israel. (firstname.lastname@example.org).