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THURSDAY, Oct. 6 (HealthDay News) -- The neurodevelopmental outcomes in neonates with herpes simplex virus (HSV) infection and central nervous system (CNS) involvement improve with six months of acyclovir suppressive therapy, according to a study published in the Oct. 6 issue of the New England Journal of Medicine.
David W. Kimberlin, M.D., from the University of Alabama at Birmingham, and colleagues investigated the efficacy and safety of long-term antiviral administration during infancy in 74 neonates with HSV infection enrolled in two studies (45 neonates with CNS involvement in one study, and 29 with skin, eye, and mouth involvement in another study). All participants received 14 to 21 days of parenteral acyclovir, after which they were randomly assigned to either placebo or six months of suppressive therapy with oral acyclovir (300 mg per square meter per dose, administered three times daily). Participants with cutaneous recurrences were treated with open-label episodic therapy. Neurodevelopmental outcomes at 12 months of age were assessed in 62 percent of the infants with CNS involvement by the Mental Development Index of the Bayley Scales of Infant Development (scores ranging from 50 to 150; higher scores indicating better outcome).
The investigators found that, after adjusting for covariates, the Bayley mental-development scores at 12 months of age were significantly higher in infants assigned to acyclovir suppression than those assigned to placebo (P = 0.046). A trend toward more neutropenia was observed in the acyclovir versus placebo groups (P = 0.09).
"Infants surviving neonatal HSV disease with CNS involvement had improved neurodevelopmental outcomes when they received suppressive therapy with oral acyclovir for six months," the authors write.
The oral acyclovir and matching placebo used in the study were provided by GlaxoSmithKline, Alpharma USPD, and Pharm Ops. Several study authors and the editorial author disclosed financial ties to pharmaceutical companies, including GSK.
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