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A Randomized, Double-blind Multicenter Trial

Stephen L. Sacks, MD; Fred Y. Aoki, MD; Franciso Diaz-Mitoma, MD; John Sellors, MD; Stephen D. Shafran, MD

JAMA. 1996;276(1):44-49.

Abstract
Objective.
—To compare the efficacy and safety of episodic patient-initiated oral famciclovir with placebo in recurrent genital herpes.

Design.
—Randomized, double-blind, frequent-observation, dose-ranging study comparing twice-daily 125-mg, 250-mg, or 500-mg oral famciclovir with placebo. Patients initiated therapy after self-culturing, reported to the clinic within 12 hours, and were assessed twice daily for at least 5 days.

Setting.
—Fifteen Canadian university, private practice, or public outpatient clinics.

Patients.
—A total of 692 patients with culture-proven recurrent genital herpes were randomized; 467 patients experienced a symptomatic episode and commenced treatment.

Main Outcome Measure.
—Time to complete healing of all lesions.

Results.
—Famciclovir (all doses) was significantly more effective than placebo in reducing time to healing, time to cessation of viral shedding, and durations of lesion edema, vesicles, ulcers, and crusts. Times to cessation of all symptoms and of moderate to severe lesion tenderness, pain, and burning were also reduced. Patients who initiated famciclovir prior to viral shedding were more likely to not shed virus throughout. All doses were equally effective, safe, and well tolerated.

Conclusions.
—Oral famciclovir reduced the onset and duration of viral shedding, lesion persistence, and uncomfortable symptoms. Several individual symptoms and lesion stages were also reduced in duration by this episodic therapy. Additionally, our twice-daily observation trial design proved to be a helpful tool for studying recurrent disease. Episodic oral famciclovir provides a convenient and effective alternative for those patients with recurrent genital herpes whose frequency rates do not require continuous antiviral suppression.

Author Affiliations
for the Canadian Famciclovir Study Group

From the Division of Infectious Diseases, Vancouver Hospital and Health Sciences Centre, The University of British Columbia, Vancouver (Dr Sacks); Health Sciences Centre Hospital and University of Manitoba, Winnipeg (Dr Aoki); Children's Hospital of Eastern Ontario, Ottawa (Dr Diaz-Mitoma); Department of Family Medicine, McMaster University, Hamilton, Ontario (Dr Sellors); Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton (Dr Shafran).

Footnotes
A complete list of the Canadian Famciclovir Study Group appears at the end of the article.

Drs Sacks, Diaz-Mitoma, Sellors, and Shafran have received honoraria from SmithKline Beecham Pharmeceuticals (SKBP); Drs Diaz-Mitoma and Sellors have done contractual work for SKBP; Drs Sacks and Shafran have received grants-in-aid from SKBP; Dr Aoki has served on a herpes vaccine research advisory board for SKBP; and Dr Shafran has served as a paid consultant to SKBP. SmithKline Beecham Pharmeceuticals manufactures famciclovir under the name Famvir.

Reprints: Stephen L. Sacks, MD, Viridae Clinical Sciences, Inc, 1134 Burrard St, Vancouver, British Columbia, Canada V6Z 1Y8.

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