Single-dose, patient-initiated famciclovir: A randomized, double-blind, placebo-controlled trial for episodic treatment of herpes labialis - 09/08/11
, Neil Bodsworth, MD b, Harvey Resnick, MD c, Marcus Conant, MD d, Claude Oeuvray, PhD e, Joseph Gao, PhD e, Kamal Hamed, MD, MPH e
Reprint requests: Spotswood L. Spruance, MD, Division of Infectious Diseases, University of Utah School of Medicine, Room 4B319, 30 N 1900 E, Salt Lake City, UT 84132-2405.Salt Lake City, Utah; New South Wales, Australia; Lake Jackson, Texas; San Francisco, California; and East Hanover, New Jersey
Abstract |
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.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AEs, CI, HR, HSV, HSV-1, ITT, mITT, PP
Plan
| 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. |
Vol 55 - N° 1
P. 47-53 - juillet 2006 Retour au numéro
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