Pharmacoepidemiology of Antiviral Treatment for Congenital Cytomegalovirus in Neonates

OBJECTIVE: The objective was to assess the pharmacoepidemiology of ganciclovir and valganciclovir for treatment of congenital cytomegalovirus (cCMV), adverse events, and hearing screen outcomes in infants treated with antiviral therapy. METHODS: We included infants discharged from Pediatrix Medical Group neonatal intensive care units (NICUs) between 2010 and 2020. We calculated the number of infants with cCMV and the proportion treated per year. We identified infants with cCMV treated with antivirals and used logistic regression models to compare adverse events (neutropenia, thrombocytopenia, and hepatic dysfunction) before and during treatment. Hearing screen outcomes were assessed using a logistic regression model as our primary analysis, with further sensitivity analyses to allow for the possibility of endogenous treatment. RESULTS: A total of 465 infants from 144 sites met our inclusion criteria, of whom 262 received antiviral treatment. From 2010 to 2020, the annual number of infants with cCMV fell by one-third and the proportion of infants receiving antiviral treatment more than doubled. Neutropenia (absolute neutrophil count ANC