New treatment for recurrent genital herpes

Research status

Completed

Overview of Study

A randomised double-blind active-controlled parallel-group multicentre study to assess the efficacy and safety of self-initiated short course (two-day) oral Famciclovir therapy in immunocompetent patients with active recurring genital herpes.

Objectives of study

The aim of this study was to compare a five-day treatment of Famciclovir (used as standard treatment to reduce the duration of a genital herpes attack or to increase the time between recurrences), with a two-day course of Famciclovir which has in small trials previously been found to be as effective as the five-day treatment.

Anyone who experienced at least three recurrences of genital herpes infection per year were recruited. Eligible participants were randomly assigned to one of two treatment groups prior to each recurrence and were given a study kit to take home. Participants were then randomly assigned to either a two-day treatment with Famciclovir 500 mg initial dose, followed by 250 mg 12 hours later, or a standard five-day treatment with Famciclovir 125 mg given every 12 hours.

After initiating therapy participants were required to return to the clinic within 24 hours for a clinical assessment to confirm the recurrence. Two questionnaires were completed to evaluate various aspects of symptoms and functions. A return to the clinic was required for one follow-up visit on the day of completion of the five days of study medication. At that time the state of lesion healing was assessed. Participants were then re-randomised for a new course of double-blind study medication to be used for a second recurrence of genital herpes and the process repeated.