| Summary: | This study was an open-label evaluation of acyclovir for 21 days. A total of 88 infants who had been diagnosed with HSV infection were enrolled including 16 who received an intermediate dose (ID) (45 mg/kg/day) and 72 who received HD (60 mg/kg/day). Among those, 79 infants with virologically confirmed infection were included in the efficacy analysis. Clinical outcomes (neurodevelopment impairment, mortality and HSV recurrences) were assessed at up to 4 years of life. In infants with virologically confirmed infection and who received HD acyclovir (n=66), outcomes at 12 months of age were compared with the historical cohort who received SD acyclovir from the Whitley trial. The survival rate for infants treated with HD acyclovir was statistically significantly higher than for those treated with SD acyclovir (Odds Ratio: 3.3; 95% CI: 1.5 to 7.3). Recipients of HD acyclovir had a borderline significant decrease in morbidity compared with SD recipients, after adjusting for the extent of disease (SEM vs. CNS vs. disseminated), HSV type (1 vs. 2), prematurity, and disease severity (seizures)
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