Authors: Kimberlin and others
Congenital cytomegalovirus (CMV) infection is the leading nongenetic cause of sensorineural hearing loss and is the most frequent known viral cause of mental retardation; the infection affects 0.6 to 0.7% of live births in industrialized countries.
The National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Antiviral Study Group (CASG) found that among neonates with symptomatic congenital CMV disease involving the central nervous system (CNS), ganciclovir administered intravenously over a period of 6 weeks was associated with improved audiologic outcomes at 6 months of life, but there was suggestion that this benefit could wane over the first 2 years of life.
All participants received valganciclovir (at a dose of 16 mg per kilogram of body weight, orally twice daily) for 6 weeks. Participants then underwent randomization in a 1:1 ratio to receive either continued valganciclovir or placebo for 4.5 months.
Best-ear hearing at 6 months was similar in the 6-month group and the 6-week group. Total-ear hearing (hearing in one or both ears that could be evaluated) was more likely to be improved or to remain normal at 12 months in the 6-month group than in the 6-week group (73% vs. 57%, P=0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P=0.04). At 24 months, the 6-month group, as compared with the 6-week group, had better neurodevelopmental scores on the Bayley Scales of Infant and Toddler Development, third edition, on the language composite component (P=0.004) and on the receptive-communication scale (P=0.003). Grade 3 or 4 neutropenia occurred in 19% of the participants during the first 6 weeks. During the next 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the participants in the 6-month group and in 27% of those in the 6-week group (P=0.64).
Treating symptomatic congenital CMV disease with valganciclovir for 6 months, as compared with 6 weeks, did not improve hearing in the short term but appeared to improve hearing and developmental outcomes modestly in the longer term.
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