[2006] [2540.2] Effect of Ganciclovir (GCV) Therapy on Neurodevelopmental Outcomes in Symptomatic Congenital Cytomegalovirus (CMV) Infections Involving the Central Nervous System (CNS): A Randomized, Controlled Study

S. Oliver, G. Cloud, P. Sanchez, G. Demmler, W. Dankner, M. Shelton, R. Jacobs, W. Vaudry, R. Pass, S. Soong, R. Whitley, D. Kimberlin. University of Alabama at Birmingham, Birmingham, AL; Univeristy of Texas Southwestern, Dallas, TX; Baylor College of Medicine, Houston, TX; Duke University, Durham, NC; Cook Children's Medical Center, Fort Worth, TX; University of Arkansas, Little Rock, AR; University of Alberta, Edmonton, Canada.

BACKGROUND: CMV is the most common congenital infection and the most frequently identified viral cause of mental retardation. GCV therapy has been shown to improve hearing with symptomatic congenital CMV disease, but no data exist on GCV's impact on neurodevelopmental outcomes.
OBJECTIVE: To assess whether GCV therapy improves Denver Developmental Evaluations in subjects with congenital CMV disease involving the CNS.
DESIGN/METHODS: 100 subjects with symptomatic congenital CMV were enrolled in a randomized, controlled study and were randomized to receive either 6 weeks of IV GCV or no treatment. Denver Developmental Evaluations were performed at 6 weeks, 6 months, and 12 months. Developmental milestones which ≥ 90% of normal children would be expected to have achieved were identified at each of these ages. Each subject was evaluated to determine the number of milestones not met (delays). The average delay per subject was compared for those who received GCV versus those who received no treatment.
RESULTS: Assessments were available for 74, 74, and 72 subjects at 6 weeks, 6 months, and 12 months, respectively. At the 6 week assessment, the average delays per subject were 1.5 for GCV recipients and 2.05 for 'no treatment' subjects (P=.13). At 6 months, the average delays were 4.46 and 7.51, respectively (P=.06). At 12 months, the average delays were 9.78 and 17.14, respectively (P=.007). After using multivariate ANOVAs to adjust for factors known to be related to poor developmental outcomes in congenital CMV, the effect of GCV therapy remained statistically significant at 12 months (P=.007), and approached significance at 6 weeks (P=.08) and 6 months (P=.08).
CONCLUSIONS: Infants with symptomatic congenital CMV who receive 6 weeks of GCV have fewer developmental delays at 12 months compared with untreated infants. This suggests that GCV may improve neurodevelopmental outcomes in patients with symptomatic congenital CMV involving the CNS.
First Author is a Medical Student

E-PAS2006:59:2540.2