The multicenter, multinational, randomized, double-blind, placebo-controlled trial was presented in a poster session on March 4^th. The researchers compare the efficacy and safety of two self-administered regimens of famciclovir versus placebo: a single dose of 1500 mg or two 750-mg doses over 12 hours.

The treatments were administered within 1 hour of onset of prodromal symptoms, but before the appearance of herpes labialis lesions. Subjects were adults who were immunocompetent and had recurrent herpes labialis. Famciclovir 1500 mg single dose was given to 152 subjects; famciclovir 750 mg twice 12 hours apart was given to 157 subjects; 168 subjects received placebo.

Subjects went to the clinic within 24 hours for initial clinical assessment; they also returned daily for 3 consecutive days. Thereafter, subjects with persistent lesions were requested to return every other day until all lesions healed, or until day 14, whichever came first.

The two famciclovir regimens reduced time-to-healing of all vesicular lesions, with median times of 4.5 and 4.1 days for the single and the double doses, respectively, compared to 6.6 days for placebo.

The investigators found no difference between the two regimens of famciclovir in time-to-healing of vesicular lesions. Adverse events in the famciclovir groups were similar to those in the placebo group.

"Famciclovir is well tolerated, convenient, and an effective therapy that has the potential for improving patient compliance," the authors concluded.

Famciclovir tablets are FDA-approved for the treatment or suppression of recurrent genital herpes in immunocompetent patients, the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients and the treatment of acute herpes zoster (shingles).

The research was supported by Novartis Pharmaceuticals Corporation. The study's first author was Spotswood Spruance, MD, University of Utah School of Medicine, Salt Lake City, Utah, United States.


[Presentation title: Time to Healing of Recurrent Herpes Labialis Lesions is Reduced With a Single High Dose of Patient-initiated Famciclovir. Abstract P2012]

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