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A controlled trial comparing vidarabine with acyclovir in neonatal herpes simplex virus infection. Infectious
Insights
Vidarabine and acyclovir showed similar outcomes for neonatal herpes simplex virus (HSV) infections. This study found no significant differences in mortality or morbidity between the two antiviral treatments for infants with HSV.
Area of Science:
- Neonatal Medicine
- Infectious Diseases
- Pharmacology
Background:
- Neonatal herpes simplex virus (HSV) infection presents significant morbidity and mortality despite vidarabine treatment.
- A controlled trial was conducted to compare vidarabine with acyclovir for treating neonatal HSV infections.
Purpose of the Study:
- To compare the efficacy and safety of vidarabine versus acyclovir in treating neonatal herpes simplex virus (HSV) infection.
- To assess outcomes including mortality and morbidity in neonates treated with either vidarabine or acyclovir.
Main Methods:
- A randomized, blinded, multicenter trial involving neonates under one month with confirmed HSV infection.
- Participants received either intravenous vidarabine (30 mg/kg/day) or acyclovir (30 mg/kg/day) for 10 days.
- Outcomes were compared overall and stratified by disease extent: localized, encephalitis, or disseminated disease.
Main Results:
- No significant differences in morbidity (P=0.83) or mortality (P=0.27) were observed between vidarabine and acyclovir groups after adjusting for disease severity.
- Mortality rates for encephalitis were 14% for both treatments; for disseminated disease, mortality was 50% for vidarabine and 61% for acyclovir.
- Normal development at one year varied: 88% for localized HSV (vidarabine) vs. 98% (acyclovir), encephalitis survivors 43% vs. 29%, and disseminated disease survivors 58% vs. 60%.
Conclusions:
- Vidarabine and acyclovir demonstrate comparable outcomes for neonatal HSV infections in this study.
- The study lacked sufficient statistical power to detect significant differences within specific disease subgroups.
- Both antiviral agents were found to be safe, with no serious toxic effects reported.
Background:
Despite the use of vidarabine, herpes simplex virus (HSV) infection in neonates continues to be a disease of high morbidity and mortality. We undertook a controlled trial comparing vidarabine with acyclovir for the treatment of neonatal HSV infection.
Methods:
Babies less than one month of age with virologically confirmed HSV infection were randomly and blindly assigned to receive either intravenous vidarabine (30 mg per kilogram of body weight per day; n = 95) or acyclovir (30 mg per kilogram per day; n = 107) for 10 days. Actuarial rates of mortality and morbidity among the survivors after one year were compared overall and according to the extent of the disease at entry into the study (infection confined to the skin, eyes, or mouth; encephalitis; or disseminated disease).
Results:
After adjustment for differences between groups in the extent of disease, there was no difference between vidarabine and acyclovir in either morbidity (P = 0.83) or mortality (P = 0.27). None of the 85 babies with disease confined to the skin, eyes, or mouth died. Of the 31 babies in this group who were treated with vidarabine and followed for a year, 88 percent (22 of 25) were judged to be developing normally after one year, as compared with 98 percent (45 of 46) of the 54 treated with acyclovir (95 percent confidence interval for the difference, -4 to 24). For the 71 babies with encephalitis, mortality was 14 percent with vidarabine (5 of 36) and with acyclovir (5 of 35); of the survivors, 43 percent (13 of 30) and 29 percent (8 of 28), respectively, were developing normally after one year (95 percent confidence interval for the difference, -11 to 39). For the 46 babies with disseminated disease, mortality was 50 percent (14 of 28) with vidarabine and 61 percent (11 of 18) with acyclovir (95 percent confidence interval for the difference, -20 to 40); of the survivors, 58 percent (7 of 12) and 60 percent (3 of 5), respectively, were judged to be developing normally after one year (95 percent confidence interval for the difference, -40 to 50). Both medications were without serious toxic effects.
Conclusions:
In this multicenter, randomized, blinded study there were no differences in outcome between vidarabine and acyclovir in the treatment of neonatal HSV infection. The study lacked statistical power to determine whether there were sizable differences within the subgroups of those with localized HSV, encephalitis, or disseminated disease.