FAMCICLOVIR FOR THE TREATMENT OF ACUTE HERPES-ZOSTER - EFFECTS ON ACUTE DISEASE AND POSTHERPETIC NEURALGIA - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective: To document the effects of treatment with famciclovir on th e acute signs and symptoms of herpes zoster and postherpetic neuralgia . Design: A randomized, double-blind, placebo-controlled, multicenter trial. Setting: 36 centers in the United States, Canada, and Australia . Patients: 419 immunocompetent adults with uncomplicated herpes teste r. Intervention: Patients were assigned within 72 hours of rash onset to famciclovir, 500 mg; famciclovir, 750 mg; or placebo, three times d aily for 7 days. Measurements: Lesions were assessed daily for as long as 14 days until full crusting occurred rand then weekly until the le sions healed. Viral cultures were obtained daily while vesicles were p resent. Pain was assessed at each of the visits at which lesions were examined and then monthly for 5 months after the lesions healed. Safet y was assessed throughout the study. Results: Famciclovir was well tol erated, with a safety profile similar to that of placebo. Famciclovir accelerated lesion healing and reduced the duration of viral shedding. Most importantly, famciclovir recipients had faster resolution of pos therpetic neuralgia (approximately twofold faster) than placebo recipi ents; differences between the placebo group and both the 500-mg famcic lovir group (hazard ratio, 1.7 [95% CI, 1.1 to 2.7]) and the 750-mg fa mciclovir group (hazard ratio, 1.9 [CI, 1.2 to 2.9]) were statisticall y significant (P = 0.02 and 0.01, respectively), The median duration o f postherpetic neuralgia was reduced by approximately 2 months. Conclu sions: Oral famciclovir, 500 mg or 750 mg three times daily for 7 days , is an effective and well-tolerated therapy for herpes tester that de creases the duration of the disease's most debilitating complication, postherpetic neuralgia.