Longer therapy with oral valganciclovir may modestly improve long-term developmental outcomes and hearing in neonates with symptomatic congenital cytomegalovirus (CMV) disease, reports a study in the New England Journal of Medicine.
Roberta L. DeBiasi, MD, MS, of the Children’s National Health System, and colleagues randomized 96 neonates with symptomatic CMV disease to receive either six weeks or six months of treatment with oral valganciclovir. The primary endpoint was the change in hearing in the better ear (“best-ear” hearing) from baseline to six months. Change in hearing from baseline to follow-up at 12 and 24 months and neurodevelopmental outcomes were secondary end points in the study.
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Best-ear hearing at six months was similar in the six week and six month groups (two and three participants had improvement; 36 and 37 had no change, and five and three had worsening, respectively; P=0.41). A greater improvement in total-ear hearing or protection of normal hearing was observed at 12 months in the group receiving six months of therapy vs. six weeks (73% vs. 57%,P=0.01). The benefit in total-ear hearing was maintained at 24 months (77% vs. 64%, P=0.04). The six-month 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) at 24 months compared to the six-week group. Grade 3 or 4 neutropenia was observed in 19% of the participants during the first six week; in the follow 4.5 months of the study, grade 3 or 4 neutropenia occurred in 21% of the six-month group and in 27% of the six-week group (P=0.64).
While this study doesn’t show that oral valganciclovir can prevent all hearing and developmental deficits, it does indicate that longer treatment could result in improved outcomes compared to shorter treatment, states Dr. DeBiasi.
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