WASHINGTON, D.C. -- 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 treatment that has demonstrated that a single day of therapy is effective in the treatment of RGH.
"Current standard of care for recurrent genital herpes is three or five days of oral antiviral therapy. In this study, it is thought that Famvir was effective in a single-day dose because it provided a full course of therapy upfront when the virus is most active," said Dr. Fred Aoki, professor of medicine at the Medical Microbiology and Pharmacology and Therapeutics, University of Manitoba, and lead investigator in the study. "This is exciting news for physicians who treat people with genital herpes because controlling an outbreak with a single day of treatment has the potential to impact the overall management of recurrent genital herpes."
The research, presented today at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) also showed 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 Corporation filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for a single-day Famvir treatment indication in the fall of 2005.
"Millions of Americans are living with this condition and trying to cope with the pain and discomfort each outbreak brings," said Alex Gorsky, CEO of Novartis Pharmaceuticals Corporation. "We are responding to those with recurrent genital herpes to bring them a single-day treatment option that can actually prevent their initial symptoms from becoming a full outbreak. This study with single-day Famvir underscores our commitment to continue to make RGH more manageable for Americans living with this condition."
Results from the multicenter, 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 percent vs. 12.7 percent; 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 event frequency and severity in the Famvir group were infrequent overall, of mild to moderate severity and similar to those in the placebo group.
Genital herpes is one of the most common sexually transmitted diseases in the United States. Approximately one in five or about 50 million Americans are infected with genital herpes. Nearly 90 percent of people affected with genital herpes may not know they are infected. 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.