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Efficacy and Safety of a Weight-based Dosing Regimen of Valganciclovir for Cytomegalovirus Prophylaxis in Pediatric Solid-organ Transplant Recipients

Pappo, Adi MD1; Peled, Orit PharmD2; Berkovitch, Matitiahu MD3,4; Bilavsky, Efraim MD1,4; Rom, Eran MD1,4; Amir, Jacob MD1,4; Krause, Irit MD1,4; Yarden-Bilavsky, Havatzelet MD4,5; Scheuerman, Oded MD4,6,7; Ashkenazi-Hoffnung, Liat MD4,6,7

doi: 10.1097/TP.0000000000002632
Original Clinical Science—General
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Background. 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.

Methods. 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.

Results. 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.

Conclusions. 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. (ashkenazi.liat@gmail.com).

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.