ORAL FAMCICLOVIR FOR THE SUPPRESSION OF RECURRENT GENITAL HERPES - A RANDOMIZED CONTROLLED TRIAL

Context.-Recurrent genital herpes simplex virus (HSV) may be treated e pisodically, but this may not be sufficient for patients with frequent recurrences. Objective.-To determine the efficacy and safety of famci clovir in the suppression of recurrent genital HSV infection Design.-A randomized, double-blind, placebo-controlled, parallel-group study.Se tting.-Thirty university, hospital, or private outpatient referral cen ters 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 episode s of genital herpes during 12 of the most recent 24 months, in the abs ence 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 re currence of genital HSV infection; the proportion of patients remainin g free of HSV recurrence at 6 months; frequency of adverse events. Res ults.-ln an intent-to-treat analysis, famciclovir significantly delaye d the time to the first recurrence of genital herpes at all dose regim ens (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 p lacebo recipients. The proportion of patients remaining free of HSV re currence was approximately 3 times higher in famciclovir recipients (7 9%-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 pl acebo. Conclusions.-Oral famciclovir (125 mg or 250 mg 3 times daily o r 250 mg twice daily) is an effective, well-tolerated treatment for th e suppression of genital HSV infection in patients with frequent recur rences.