"The study demonstrated two very important aspects of the treatment of these bouts of genital herpes with famciclovir," Fred Aoki, MD, Professor of Medicine, Medical Microbiology and Pharmacology and Therapeutics, University of Manitoba, Winnipeg, Canada, in a poster session on March 5^th. "First, it demonstrated that famciclovir would prevent progression to a full outbreak, and it demonstrated that treatment in this manner shortens the duration of the outbreak itself."

Famciclovir is 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).

Dr. Aoki and colleagues enrolled 329 subjects with recurrent genital herpes in a multicenter, multinational, randomized, double-blind, placebo-controlled study comparing 1-day famciclovir 1000 mg bid twice daily (n = 163) with placebo (n = 166).

Subjects self-initiated treatment within 6 hours of onset of prodromal symptoms and at the first sign of a genital herpes lesion. They were required to return to the clinic within 24 hours of initiating therapy (day 1) and on days 2 and 3. Subjects with persistent lesions returned to the clinic on days 4 and 5, and then every other day until all lesions healed, or until day 14. Subjects kept a twice-daily diary of their genital herpes symptoms.

The researchers defined healing as loss of all crusts and re-epithelialization of lesions. They defined aborted lesions as those that did not progress beyond papule stage.

Results show that healing time was faster in famciclovir-treated patients than in placebo-treated patients for nonaborted lesions (median time, 4.3 vs. 6.1 days; P <.001) and all lesions (median time, 3.5 vs. 5.0 days; P <.001). Famciclovir treatment also appeared to increase the proportion of patients with aborted lesions compared with the placebo group (23.3% vs. 12.7%; P =.003).

Famciclovir was faster than placebo in resolving all symptoms (median time for all comparisons, 3.3 vs. 5.4 days; P <.001) and each individual symptom (P <.05 for all comparisons): pain (0.9 vs. 1.5 days), burning (0.7 vs. 1.0 days), tingling (1.0 vs. 1.4 days), itching (1.6 vs. 2.7 days), and tenderness (2.0 vs. 3.4 days).

Adverse events were similar in the treated and placebo groups.

"Currently what's in the market place requires 3 to 5 days worth of treatment for a bout of recurrent genital herpes," Dr. Aoki said.

"The data is exciting with famciclovir because they show that a 1-day treatment can be both effective and well tolerated," he said.

The study was supported by Novartis Pharmaceuticals Corporation.


[Presentation title: A Double-Blind, Randomized, Placebo-Controlled Trial of 1-Day, Patient Initiated Famciclovir 1000 mg BID for the Treatment of Recurrent Genital Herpes. Abstract P2010]

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