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Famciclovir for the Treatment of Acute Herpes Zoster: Effects on Acute Disease and Postherpetic Neuralgia: A Randomized, Double-Blind, Placebo-Controlled Trial

Stephen Tyring; Rick A. Barbarash; James E. Nahlik; Anthony Cunningham; John Marley; Madalene Heng; Terry Jones; Ted Rea; Ron Boon; Robin Saltzman, The Collaborative Famciclovir Herpes Zoster Study Group*
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From the University of Texas Medical Branch, Galveston, Texas. St. John Hospital, Nassau Bay, Texas. St. Louis University and Deaconess Family Medicine, St. Louis, Missouri. Westmead Hospital, Westmead, Australia. University of Adelaide, Adelaide, Australia. Veterans Administration Medical Center, Sepulveda, California. Volunteers in Pharmaceutical Research, Bryan, Texas. SmithKline Beecham Pharmaceuticals, Brentford, United Kingdom and Philadelphia, Pennsylvania. Requests for Reprints: Stephen Tyring, MD, PhD, University of Texas Medical Branch, Route J-19, Galveston, TX 77555. Grant Support: By a grant from SmithKline Beecham Pharmaceuticals and in part by General Clinical Research Center grant M01 RR0073 from the National Institutes of Health, Department of Health and Human Services.

Copyright ©2004 by the American College of Physicians

Ann Intern Med. 1995;123(2):89-96. doi:10.7326/0003-4819-123-2-199507150-00002
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Objective: To document the effects of treatment with famciclovir on the 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 zoster.

Intervention: Patients were assigned within 72 hours of rash onset to famciclovir, 500 mg; famciclovir, 750 mg; or placebo, three times daily for 7 days.

Measurements: Lesions were assessed daily for as long as 14 days until full crusting occurred and then weekly until the lesions healed. Viral cultures were obtained daily while vesicles were present. Pain was assessed at each of the visits at which lesions were examined and then monthly for 5 months after the lesions healed. Safety was assessed throughout the study.

Results: Famciclovir was well tolerated, 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 postherpetic neuralgia (approximately twofold faster) than placebo recipients; differences between the placebo group and both the 500-mg famciclovir group (hazard ratio, 1.7 [95% CI, 1.1 to 2.7]) and the 750-mg famciclovir group (hazard ratio, 1.9 [CI, 1.2 to 2.9]) were statistically significant (P = 0.02 and 0.01, respectively). The median duration of postherpetic neuralgia was reduced by approximately 2 months.

Conclusions: Oral famciclovir, 500 mg or 750 mg three times daily for 7 days, is an effective and well-tolerated therapy for herpes zoster that decreases the duration of the disease's most debilitating complication, postherpetic neuralgia.

*For members of the Collaborative Famciclovir Herpes Zoster Study Group, see Appendix.


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Figure 1.
Time to the resolution of postherpetic neuralgia (intention-to-treat analyses). Top.PPBottom.PP

Time to the resolution of postherpetic neuralgia (PHN) for all patients by treatment group, 500-mg famciclovir compared with placebo ( = 0.02) and 750-mg famciclovir compared with placebo ( = 0.005). Time to the resolution of postherpetic neuralgia for patients 50 years of age or older by treatment group, 500-mg famciclovir compared with placebo ( = 0.0044) and 750-mg famciclovir compared with placebo ( = 0.0030). The numbers at the bottom of each part are the numbers of patients assessed for pain at each monthly visit after lesions had healed.

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