Duration of Valganciclovir Treatment for Symptomatic Congenital CMV Disease

Previously, the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group found that among neonates with symptomatic congenital cytomegalovirus (CMV) disease involving the central nervous system (CNS), 6 weeks of intravenous ganciclovir was associated with improved audiologic outcomes at age 6 months, but that this benefit could wane over time (J Pediatr 2003;143:16). They subsequently determined that oral valganciclovir — the prodrug of ganciclovir — could be substituted for ganciclovir. Now, in a randomized, placebo-controlled trial conducted at 40 study sites, they have examined the possible benefits of extending treatment to 6 months.

Ninety-six infants with symptomatic congenital CMV disease were randomized to receive oral valganciclovir, 16 mg per kg orally twice daily, either for 6 months or for 6 weeks, plus placebo for an additional 4.5 months. All had a gestational age of ≥32 weeks, were aged ≤30 days, and weighed ≥1800 g at initiation of therapy.

The primary endpoint — change in “best-ear” hearing between baseline and 6 months — was similar between groups. However, in assessments of changes in best- or total-ear hearing between baseline and 12 and 24 months, 6-month–group participants were more likely to show improvement or to have maintained normal hearing. The 6-month group also had better Bayley III language-composite and receptive-communication scale scores at 24 months. Viral load was lower in 6-month–group participants only during the period when they were receiving the drug and the others were receiving placebo. Rates of adverse events were similar between groups.