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Valacyclovir may be a suitable treatment for VZV and HSV infections
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Valacyclovir oral suspension produced favorable acyclovir blood concentrations and was well tolerated in children aged 3 months to 11 years, according to study results.
Researchers conducted three phase-1, open-label, multicenter studies to determine the pharmacokinetics and safety of the valacyclovir oral suspension formula in children with or at risk for herpesvirus infection. These trials took place at 15 sites in Australia, Chile, Estonia, South Africa and the United States.
In the studies, the researchers administered a single 25 mg/kg dose of valacyclovir oral suspension (n=57) to children aged 1 month to 5 years. Children aged 1 to 11 years were assigned to 10 mg/kg twice daily for three to five days (herpes simplex virus infection; n=28) or 20 mg/kg three times daily for five days (varicella-zoster virus infection; n=27).
Among the 112 children participating in the studies, 27 reported mild or moderate adverse events — eight of which the researchers considered to be drug-related. Three more children experienced serious adverse events: enteroviral meningitis; diarrhea, vomiting and dehydration; and pneumonia. However, the researchers concluded none of these serious adverse events were drug-related. There were no reports of deaths or thrombotic thrombocytopenic purpura, hemolytic uremic syndrome or thrombotic microangiopathies.
Pharmacokinetic results also indicated that valacyclovir was rapidly absorbed after oral administration and extensively converted to acyclovir. The drug was well tolerated at doses of 10 mg/kg and 20 mg/kg administered two to three times daily in children aged 3 months to 11 years.
The pharmacokinetic data and safety profile from the three studies led the researchers to recommend 20 mg/kg administered twice daily for HSV infections and three times daily for VZV infections. Additionally, they said valacyclovir oral suspension can be considered in the treatment of gingivostomatitis, chickenpox or herpes zoster in immunocompetent children.
Kimberlin DW. Clin Infect Dis. 2010;50:221-228.