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Single-Day Famvir (Famciclovir) Treatment Found To Shorten the Duration of Recurrent Genital Herpes Outbreaks

DORVAL, QUEBEC -- January 12, 2006 -- Results from a new study demonstrated that a single day of treatment with the antiviral Famvir* (famciclovir) stopped the progression to a full outbreak or shortened the duration of an outbreak in patients with recurrent genital herpes (RGH).

With the completion of this study, Famvir* is the only antiviral that has demonstrated efficacy with a single day of therapy in the treatment of RGH.

"Although the current standard of care for recurrent genital herpes is three or five days of oral antiviral therapy, in this study Famvir* was effective as a single day treatment," said Dr. Fred Aoki, Professor of Medicine, Medical Microbiology and Pharmacology and Therapeutics, University of Manitoba, and lead investigator in the study. "A single-day dose of Famvir is thought to be effective because it provided a full course of therapy upfront when the virus is most active. This is exciting news for physicians and patients. Since the virus can cause social and emotional problems and even lead to isolation and depression, controlling an outbreak with a single day of treatment has the potential to impact not only the overall management of the disease, but also the quality of life of the patients."

The research, published in the January 1, 2006 issue of Clinical Infectious Diseases, also shows that Famvir* significantly reduced the duration of RGH symptoms including the itching, pain, burning, tingling and tenderness in patients with lesions versus placebo. Based on these findings, Novartis Pharmaceuticals Canada Inc. is considering filing a supplemental new drug submission (sNDS) with Health Canada for a single-day Famvir treatment indication.

Results from the multi-centre, multinational, randomized, double-blind, placebo-controlled study comparing single-day Famvir* (1g orally twice; n=163) with placebo (n=166) showed that when patients with RGH initiated therapy with Famvir* at the first sign of an outbreak (within six hours), Famvir* significantly reduced the time to healing of non-aborted lesions by two days (median time, 4.3 vs. 6.1 days; P<0.001). Furthermore, the proportion of patients with aborted lesions was significantly larger in the Famvir* group (23.3% vs. 12.7%; P=0.003) compared to placebo.

Famvir* also significantly reduced the duration of all studied symptoms including the itching, pain, burning, tingling and tenderness in patients with lesions vs. placebo (median time 3.3 vs. 5.4 days; P < 0.001). Adverse events in the Famvir* group were infrequent overall, of mild to moderate severity and similar to those in the placebo group.

About Genital Herpes
Recurrent genital herpes is one of the most common sexually transmitted diseases worldwide. Approximately one in five or about 50 million Americans are infected with genital herpes. Nearly 90% of people affected with genital herpes may not know they are infected with the disease. Anyone who is sexually active with an infected partner can get genital herpes, however, typically more women are diagnosed with genital herpes than men.

There is no cure for genital herpes. Oral antiviral medications such as Famvir* are indicated to treat or suppress RGH. People with genital herpes can treat it suppressively, taking medication every day, or episodically, taking medication when each outbreak occurs. The majority of people who use prescription treatment for genital herpes manage their symptoms through episodic treatment.

About Famvir*
Famvir* (famciclovir) is indicated for the treatment of acute herpes zoster (shingles) as well as to treat or suppress recurrent episodes of genital herpes in immunocompetent adults. Famvir* is also indicated for the treatment of recurrent episodes of herpes simplex infections in HIV-infected-patients.


SOURCE: Novartis

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