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JAMA. 1998 Sep 9;280(10):887-92.

Oral famciclovir for the suppression of recurrent genital herpes: a randomized controlled trial. Collaborative Famciclovir Genital Herpes Research Group.

Author information

1
Children's Hospital of Eastern Ontario, Ottawa, Canada. diaz@cheo.on.ca

Abstract

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.

PMID:
9739972
DOI:
10.1001/jama.280.10.887
[Indexed for MEDLINE]

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