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

https://doi.org/10.1016/j.jaad.2006.02.031Get rights and content

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.

Section snippets

Study design

This multinational, multicenter, randomized, double-blind, placebo-controlled study of patient-initiated therapy assessed famciclovir (1500 mg once [single dose] and 750 mg twice a day for 1 day [single day]) in immunocompetent adults with recurrent herpes labialis. The study was conducted at 28 centers in the United States, 10 centers in Canada, and 3 centers in Australia from October 2003 to January 2005. The protocol and patient consent forms were approved by the institutional and/or central

Results

A total of 1417 patients were screened, of whom 1376 met the entry criteria and were randomized and given study medication. In all, 701 patients had symptoms of a recurrence, started study medication, and were analyzed in the safety (ITT) population. In all, 477 patients developed vesicles (mITT population), and 375 patients developed vesicles and had no major protocol violations (PP population). The most common violations were related to noncompliance with study medication instructions, such

Discussion

The results of this study demonstrated that a single 1500-mg dose of patient-initiated famciclovir is both effective and safe for recurrent herpes labialis. Single-dose famciclovir reduced the time to healing (loss of crust and re-epithelialization) of vesicular herpes labialis lesions and the time to return to normal skin of all lesions by approximately 2 days compared with placebo. In addition, single-dose famciclovir resolved the pain and tenderness associated with a herpes labialis outbreak

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Novartis provided statistical and other analyses and the study medication (active and placebo).

Disclosure: Dr Spruance has received research funding from, was an investigator for, and has been a scientific consultant for Novartis. Dr Bodsworth has been a scientific consultant for, has received research funding from, and was an investigator for Novartis. Drs Resnick and Conant have been research investigators for Novartis. Drs Oeuvray, Gao, and Hamed are employees of Novartis.

Presented at the European Academy of Dermatology and Venereology, October 13, 2005, London, England, and the American Academy of Dermatology Congress, March 4, 2006, San Francisco, California.

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