A RANDOMIZED DOUBLE-BLIND SURVEY ON THE EFFECT OF BRIVUDIN IN THE PREVENTION OF POSTHERPETIC PAIN IN COMPARISON WITH ACYCLOVIR

*S.W. Wassilew (1), B.M. Stubinski (2), G. Stätdler (2), I. Koch (2), K. Schumacher (2), A. Neubauer (2), on behalf of the Collaborative Brivudin PHN Study Group
Dermatologic Department, Klinikum Krefeld, Germany;
Berlin-Chemie / Menarini Group, Berlin, Germany

Study Objective:
To determine the efficacy of brivudin in the prevention of postherpetic pain in comparison with acyclovir.
Design:
Double-blind survey evaluating data obtained from participants of a randomized herpes zoster trial which compared the efficacy of brivudin and acyclovir in acute herpes zoster. The survey covered a period of 8 to 11 months after the end of the herpes zoster trial.
Setting:
147 centers in 7 European countries.
Patients:
608 immunocompetent patients with herpes zoster, aged 50 years or older. Baseline characteristics were comparable in the two treatment groups.
Treatments:
Oral brivudin 125 mg once daily versus oral acyclovir 800 mg five times daily, both for 7 days. Treatment started within 48 hours after first vesicular eruption.
Main Results:
A total of 662 patients from the herpes zoster trial were selected under double-blind conditions to evaluate the incidence of postherpetic pain after study termination (main selection criterion: age > 50 years). Of these, 608 patients (brivudin: 309, acyclovir: 299) were willing to participate. During the survey period, the incidence of postherpetic pain was significantly lower after brivudin therapy (32.7%) than after treatment with acyclovir (43.5%, P=0.006). The prevalence of postherpetic pain decreased steadily during the survey period, with the difference between the treatment groups remaining constantly in favor of brivudin [month 1: 28.3% (brivudin) vs. 38.5% (acyclovir); P=0.01, month 2: 25.1% (brivudin) vs. 34.7% (acyclovir); P=0.01, month 3: 19.1% (brivudin) vs. 26.7% (acyclovir), P=0.03]. The duration of postherpetic pain, measured by the median time from start of treatment to resolution of pain, was comparable in both treatment groups (brivudin: 119 days, acyclovir: 116 days, RR: 1.11 CI: 0.93-1.32), as was the maximum intensity of pain (mostly 1 = "mild" or 2 = "discomforting" in a ranking scale from 0 = "no pain" to 5 = "unbearable pain").
Conclusions:
Brivudin 125 mg once daily is significantly more effective in the prevention of postherpetic pain than standard acyclovir.

Corresponding Author: Prof. Dr. S. W. Wassilew, Director of the Dermatologic Department, Klinikum Krefeld, Lutherplatz 40, 47805 Krefeld, Germany