Oral Valganciclovir Treatment in a CMV Congenital Infected Infant with Sensorineural Hearing Loss (SNHL) First Detected at 4 Months of Age

Introduction

Cytomegalovirus (CMV) is the most frequent cause of congenital viral infections with an incidence of 0.3–2.2% in developed countries of all life births. Fetal CMV-infection can develop following both primary and recurrent maternal infections and is the leading cause of nongenetic sensorineural hearing loss (SNHL) and mental retardation. Congenital infected newborns are symptomatic in 12.7% of newborns with hearing loss in 41%, being bilateral in 67%. In infants with asymptomatic infection at birth 13.5% will eventually show developmental disorders, notably SNHL in 7.4% [Dollard S. et al. Rev Med Virol 2007; 17: 355–363; Dahle A. J. et al. J Am Acad Audiol 2000; 11: 283–290]. Antiviral treatment of congenital infected newborns and infants with CNS involvement with intravenous ganciclovir was investigated in a large randomised US-multicenter trial (phase I–III) and demonstrated both virologic and clinical benefit. Following an initial i. v. ganciclovir therapy for 2–3 weeks the orally applicable prodrug valganciclovir has been used for “off-label” long term treatment since 2005. Recently, the pharmaco-kinetic and dynamic characteristics of valganciclovir for use in symptomatic infected neonates have been established [Kimberlin D. W. et al. J Infect Dis 2008; 197: 836–845].