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Valcyte improved hearing, neurodevelopmental outcomes among neonates with symptomatic CMV
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Six months of therapy with Valcyte did not improve short-term hearing among neonates with symptomatic congenital cytomegalovirus, but did improve hearing and neurodevelopmental outcomes in the long term in a recent study.
“Although congenital CMV infection is rare overall, it accounts for 21% of children with hearing loss at birth and 24% of those with hearing loss at 4 years of age,” study researcher David W. Kimberlin, the Sergio Stagno Endowed Chair in Pediatric Infectious Diseases, and co-director of the division of pediatric infectious diseases at the University of Alabama at Birmingham, and colleagues wrote. “[According to recent data] among neonates with symptomatic congenital CMV disease involving the central nervous system, 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.”
David W. Kimberlin
Ninety-six neonates (aged 30 days or younger) with symptomatic congenital CMV from 40 study sites were enrolled in the study. All participants received Valcyte (valganciclovir, Genentech) for 6 weeks and then were randomly assigned continued valganciclovir (n = 47) or placebo (n = 49) for 4.5 months. Researchers assessed hearing, neurological impairment and adverse events from baseline to 24 months.
Change in best-ear hearing from baseline to 6 months was similar between children who received therapy for 6 weeks or 6 months (P = .41).
After adjusting for CMV disease involving the central nervous system at baseline, children who received 6 months of therapy were more likely to have improved total-ear hearing or maintained normal hearing between baseline and 12 months vs. children who received 6 weeks of therapy (73% vs. 57%; OR = 3.04; 95% CI, 1.26-7.35).
At 24 months, hearing improvements among children who received longer therapy were maintained.
Children who received 6 months of therapy had higher Bayley-III language-composite (P = .005) and higher receptive-communication scale scores (P = .003) at 24 months compared with those who received 6 weeks of therapy.
Nineteen percent of neonates had grade 3 or 4 neutropenia during the first 6 weeks of valganciclovir therapy. From 6 weeks through 6 months, 21% of those who received longer therapy had grade 3 or 4 neutropenia vs. 27% of those who received placebo (P = .64).
Timing of therapy initiation (aged more than 3 weeks vs. 3 to 4 weeks) was not associated with hearing outcomes at 12 or 24 months.
“We found that the group treated with the longer course had improved and more durable hearing outcomes and also had better developmental outcomes,” Kimberlin told Infectious Diseases in Children. “The likelihood of neutropenia as a side effect of valganciclovir was not increased in the group receiving longer therapy, although there might be an increase in liver tests around months 4 and 5 in the longer-treated group. I believe that these data will lead to more babies with symptomatic congenital CMV disease being treated for 6 months with oral valganciclovir.” – by Amanda Oldt
Disclosure: Kimberlin reports other support from the NIH/NIAID/DMID during the study, and grant support from GlaxoSmithKline and Gilead outside the submitted work. Please see the full study for a list of all other authors’ relevant financial disclosures.
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