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A Randomized Controlled Trial

Francisco Diaz-Mitoma, MD, PhD; R. Gary Sibbald, MD; Stephen D. Shafran, MD; Ron Boon; Robin L. Saltzman, MD; for the Collaborative Famciclovir Genital Herpes Research Group

JAMA. 1998;280:887-892.

Context.— Recurrent genital herpes simplex virus (HSV) may be treated episodically, but this may not be sufficient for patients with frequent recurrences.

Objective.— To determine the efficacy and safety of famciclovir in the suppression of recurrent genital HSV infection.

Design.— A randomized, double-blind, placebo-controlled, parallel-group study.

Setting.— Thirty university, hospital, or private outpatient referral centers in Canada and Europe.

Patients.— A total of 455 patients (223 men, 232 women) aged 18 years or older with a history of 6 or more episodes of genital herpes during 12 of the most recent 24 months, in the absence of suppressive therapy, received study medication.

Intervention.— Oral famciclovir, 125 mg or 250 mg 3 times daily or 250 mg twice daily, or placebo for 52 weeks.

Main Outcome Measures.— Time to the first recurrence of genital HSV infection; the proportion of patients remaining free of HSV recurrence at 6 months; frequency of adverse events.

Results.— In an intent-to-treat analysis, famciclovir significantly delayed the time to the first recurrence of genital herpes at all dose regimens (hazard ratios, 2.9-3.3;P< .001); median time to recurrence for famciclovir recipients was 222 to 336 days compared with 47 days for placebo recipients. The proportion of patients remaining free of HSV recurrence was approximately 3 times higher in famciclovir recipients (79%-86%) than in placebo recipients (27%) at 6 months (relative risks, 2.9-3.1;P <.001); efficacy was maintained at 12 months. Famciclovir was well tolerated with an adverse experience profile comparable to placebo.

Conclusions.— Oral famciclovir (125 mg or 250 mg 3 times daily or 250 mg twice daily) is an effective, well-tolerated treatment for the suppression of genital HSV infection in patients with frequent recurrences.

From the Children's Hospital of Eastern Ontario, Ottawa (Dr Diaz-Mitoma), and the Women's College Hospital, Toronto, Ontario (Dr Sibbald); the Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton (Dr Shafran); SmithKline Beecham Pharmaceuticals, New Frontiers Science Park, Harlow, England (Mr Boon); and SmithKline Beecham Pharmaceuticals, King of Prussia, Pa (Dr Saltzman).

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