Cytomegalovirus (CMV) is the most common congenital infection and the most frequently identified viral cause of mental retardation. Ganciclovir therapy has been shown to improve hearing in infants with symptomatic congenital CMV disease, but no data exist on the effects of therapy on neurodevelopmental outcome. Subjects enrolled in a controlled Phase III study of treatment of symptomatic congenital CMV involving the central nervous system were randomized to receive either 6 weeks of IV ganciclovir or no treatment. Denver Developmental Tests were performed at 6 weeks, 6 months, and 12 months. Developmental milestones that ≥ 90% of normal children would be expected to have achieved were identified at each of these developmental stages. Each study subject was evaluated to determine the number of milestones not met, and these were considered “delays.” The average number of delays per subject was compared for subjects who received GCV versus those who received no treatment.

Denver assessments were available for 74, 74, and 71 subjects at 6 weeks, 6 months, and 12 months, respectively. At the 6 week assessment, the average number of delays per subject was 1.5 for GCV recipients and 2.05 for 'no treatment' subjects (p=0.15). At 6 months, the average number of delays were 4.46 and 7.51, respectively (p=0.02). At 12 months, the average number of delays were 10.06 and 17.14, respectively (p=0.007). Applying multivariate regression models to assess factors related to poor developmental outcomes, the effect of ganciclovir therapy remained statistically significant at the 12 month assessment (p=0.007).

Infants with symptomatic congenital CMV who receive six weeks of IV ganciclovir therapy have fewer developmental delays at 6 and 12 months compared with untreated infants.

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