Amber N Thomas1, Phu B Nguyen2, Jamie L Miller3, Stephen B Neely4, Teresa V Lewis3. 1. Office of Experiential Education (ANT), University of Oklahoma College of Pharmacy, Oklahoma City, OK. 2. Pharmacy Department (PBN), OU Health, Oklahoma City, OK. 3. Department of Pharmacy: Clinical and Administrative Sciences (JLM, TVL), University of Oklahoma College of Pharmacy, Oklahoma City, OK. 4. Office of Instructional Science and Assessment (SBN), University of Oklahoma College of Pharmacy, Oklahoma City, OK.
Abstract
OBJECTIVE: To determine the incidence of cytomegalovirus (CMV) DNAemia and disease, identify potential risk factors, and assess the safety and efficacy of weight-based valganciclovir dosing in pediatric post-renal transplant patients. METHODS: This single-center, retrospective study included patients ≤21 years who received a kidney transplant between January 1, 2011, and November 1, 2019, with 3 to 24 months of follow-up data. Demographics and clinical characteristics were collected to assess for potential risk factors. Descriptive statistics and logistic regressions were used to determine rates of CMV DNAemia considering clinical characteristics and chemoprophylaxis. RESULTS: Fifty-seven patients were included. The incidence of CMV DNAemia was 43.9%. Cytomegalovirus seropositive status was associated with increased risk of CMV DNAemia. Patients receiving valganciclovir for <150 days had 8.33 (95% CI, 1.68-41.29) greater odds of developing CMV DNAemia than patients receiving valganciclovir for 180 ± 30 days, p = 0.01. The median time to detectable CMV PCR after transplant was 140 days (range, 12-511 days). Cytomegalovirus DNAemia was not statistically different between those receiving weight-based vs FDA-approved valganciclovir dosing; however, patients receiving the FDA-approved dosing were more likely to develop neutropenia. Among the intermediate-risk group, the adjusted relative risk of CMV DNAemia was 0.62 (95% CI, 0.36-1.09) for those not receiving chemoprophylaxis compared with those who did. CONCLUSIONS: Risk of CMV DNAemia is higher among patients receiving valganciclovir for <150 days. Further exploration of weight-based valganciclovir dosing for CMV chemoprophylaxis in high- and intermediate-risk post-renal transplant patients is needed to minimize adverse drug effects while maintaining efficacy. Copyright. Pediatric Pharmacy Association. All rights reserved. For permissions, email: mhelms@pediatricpharmacy.org 2022.
OBJECTIVE: To determine the incidence of cytomegalovirus (CMV) DNAemia and disease, identify potential risk factors, and assess the safety and efficacy of weight-based valganciclovir dosing in pediatric post-renal transplant patients. METHODS: This single-center, retrospective study included patients ≤21 years who received a kidney transplant between January 1, 2011, and November 1, 2019, with 3 to 24 months of follow-up data. Demographics and clinical characteristics were collected to assess for potential risk factors. Descriptive statistics and logistic regressions were used to determine rates of CMV DNAemia considering clinical characteristics and chemoprophylaxis. RESULTS: Fifty-seven patients were included. The incidence of CMV DNAemia was 43.9%. Cytomegalovirus seropositive status was associated with increased risk of CMV DNAemia. Patients receiving valganciclovir for <150 days had 8.33 (95% CI, 1.68-41.29) greater odds of developing CMV DNAemia than patients receiving valganciclovir for 180 ± 30 days, p = 0.01. The median time to detectable CMV PCR after transplant was 140 days (range, 12-511 days). Cytomegalovirus DNAemia was not statistically different between those receiving weight-based vs FDA-approved valganciclovir dosing; however, patients receiving the FDA-approved dosing were more likely to develop neutropenia. Among the intermediate-risk group, the adjusted relative risk of CMV DNAemia was 0.62 (95% CI, 0.36-1.09) for those not receiving chemoprophylaxis compared with those who did. CONCLUSIONS: Risk of CMV DNAemia is higher among patients receiving valganciclovir for <150 days. Further exploration of weight-based valganciclovir dosing for CMV chemoprophylaxis in high- and intermediate-risk post-renal transplant patients is needed to minimize adverse drug effects while maintaining efficacy. Copyright. Pediatric Pharmacy Association. All rights reserved. For permissions, email: mhelms@pediatricpharmacy.org 2022.
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