This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Herpes simplex virus (HSV-1 and HSV-2) and varicella-zoster virus (VZV) infections are very common infections in man. Although primary infection in healthy hosts is frequently asymptomatic or has a relatively benign course, these infections can cause significant mortality and morbidity in neonates and in immunocompromised hosts. Significant morbidity is also seen in immunocompetent infants when infections of the mouth and gums interfere with normal eating and drinking. When oral therapy is possible, acyclovir has been widely used in pediatric patients because of the commercial availability of a suspension. The limited and variable bioavailability of acyclovir, however, requires frequent dosing. It is desirable to find new effective therapies with increased bioavailability for patients suffering form disease related to HSV infection. Penciclovir, a nucleoside analogue, possesses potent antiviral activity against HSV-1, HSV-2 and VZV. Famciclovir, the orally bioavailable form (prodrug) of penciclovir, is available in the US for the treatment of genital herpes and herpes zoster infections in immunocompetent adult patients and herpes simplex infections in immunocompromised adults. Famciclovir is a potentially interesting alternative to acyclovir therapy in pediatric patients because of the higher and more consistent bioavailability, the longer intracellular half-life of the active metabolite in infected cells and the possibility of less frequent dosing than acyclovir. However, there is only limited information concerning the safety, efficacy and pharmacokinetics of penciclovir in children. Therefore, this Section A of this study is designed to determine the single-dose safety and pharmacokinetics of famciclovir after oral administration in children aged 1-12 with HSV, Section B will evaluate the safety and tolerability following famciclovir administration over a 7 day period.
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