Single-dose, patient-initiated famciclovir: a randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis.

BACKGROUND: The brief period of viral replication in recurrent herpes labialis lesions suggests shorter therapeutic regimens are a logical episodic treatment strategy.

OBJECTIVE: We sought to assess the efficacy and safety of single-dose and single-day famciclovir treatments.

METHODS: In all, 701 randomly assigned patients self-initiated therapy with famciclovir (1500 mg once [single dose] or 750 mg twice a day for 1 day [single day]) or placebo within 1 hour of onset of the prodromal symptoms of an episode of herpes labialis. Lesion healing was monitored by diaries and frequent clinic visits.

RESULTS: Median healing times of primary (first to appear) vesicular lesions in the famciclovir single-dose, famciclovir single-day, and placebo groups were 4.4, 4.0, and 6.2 days, respectively. There was no significant difference between the famciclovir regimens. Adverse events in the famciclovir groups were similar to placebo.

LIMITATIONS: The active arms of this trial were not directly compared to other antiviral regimens.

CONCLUSION: Single-dose famciclovir reduced time to healing of herpes labialis lesions by approximately 2 days compared with placebo.