Single-Day, Patient-Initiated Famciclovir Therapy for Recurrent Genital Herpes: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background. Orally administered antiviral therapy for genital herpes improves the time to lesion healing and resolves symptoms during an outbreak. Although traditional therapy for a recurrent episode for healthy adults has consisted of twice-daily dosing for 5 days, recent studies have indicated that shorter courses of antiviral therapy are effective. This study was conducted to assess the efficacy and safety of a patient-initiated, single-day regimen of famciclovir therapy, compared with placebo, in immunocompetent adult patients with recurrent genital herpes.Methods. This multicenter, multinational, randomized, double-blind, parallel-group, placebo-controlled study compared single-day, patient-initiated oral famciclovir (1000 mg given twice daily) with placebo for the treatment of recurrent genital herpes. Patients were instructed to initiate therapy within 6 h after onset of prodromal symptoms or genital herpes lesions.Results. Famciclovir reduced ( ) the time to healing of nonaborted lesions (i.e., those that did not P ! .001 progress beyond the papule stage) (median time, 4.3 vs. 6.1 days) and all nonaborted and aborted lesions (median time, 3.5 vs. 5.0 days), compared with placebo. The proportion of patients with aborted lesions was larger in the famciclovir group than in the placebo group (23.3% vs. 12.7%;). Adverse events in the famciclovir group P p .003 were infrequent overall; most were of mild-to-moderate severity and were similar to adverse events in the placebo group.Conclusions. A single-day regimen of patient-initiated famciclovir treatment was well tolerated and safe, and the healing of recurrent genital herpes lesions occurred ∼2 days faster than with placebo. Moreover, single-day famciclovir treatment stopped the development or progression of lesions beyond the papule stage. This convenient single-day regimen has the potential for improving patient compliance and satisfaction with therapy.

Single-day famciclovir for the treatment of genital herpes: follow-up results of time to next recurrence and assessment of antiviral resistance

“…The results from the famciclovir arm of this study were very consistent with those of the famciclovir arm of Aoki's placebo-controlled study 10 .…”

“…The benefits of short-course episodic therapy include convenience, reduced cost and improved compliance. Several abbreviated short-course regimens have been shown to be as effective as traditional 5-day regimens for recurrent episodes, including 3-day therapy with valacyclovir (500mg twice-daily) 7 , 2-day therapy with higher dose acyclovir (800mg 3 times daily), 2-day therapy with famciclovir (500mg initial dose, followed by 250mg twice-daily) 9 , and higher dose single-day famciclovir therapy (1 g for two doses) 10 (Table 1). While a small, uncontrolled observational study of valacyclovir 2 g twice-daily for 1 day reported median lesion duration of 5 days, randomized controlled studies with this regimen have yet to be performed 11 .…”

Clinical and antiviral effect of a single oral dose of famciclovir administered to cats at intake to a shelter

“…If viral reactivation had not yet occurred on day 1 of the study, it is possible that a single dose of famciclovir might have been more efficacious, as was the case when used as a prophylactic drug in humans with genital herpesvirus infections (Aoki et al, 2006;Spruance et al, 2006). Doses in the current trial were selected for their potential economic and logistic advantages.…”

“…If administered to humans when symptoms commence, famciclovir can reduce the time to remission of clinical signs due to herpes simplex virus (HSV)-1 (Spruance et al, 2006) or HSV-2 (Aoki et al, 2006;Bodsworth et al, 2008). Two randomized, double-masked trials have investigated the effect of a single dose of famciclovir initiated by human patients at the onset of prodromal symptoms; both demonstrated efficacy for treatment of genital herpesvirus infections (Aoki et al, 2006;Spruance et al, 2006). Penciclovir has been used to treat disease due to HSV-1, HSV-2, varicella zoster virus and Epstein-Barr virus (Razonable, 2011).…”

“…Penciclovir has a relatively long intracellular half-life; 10 h in HSV-1 infected cells and 20 h in HSV-2 infected cells (Aoki et al, 2006). Penciclovir is converted to its active metabolite after three phosphorylation steps, the first being catalyzed by viral thymidine kinase in infected cells.…”