The Duration of Recurrent Genital Herpes Outbreaks (NAPSA)—In a new study, researchers found 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). The research 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. With the completion of this study, Famvir is the only antiviral treatment that has demonstrated 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 waseffective 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, 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 RGH because controlling an outbreak in a single day has the potential to impact the overall managementof recurrent genital herpes.” Gina, a genital herpes sufferer, agreed this is good news. “When I was first diagnosed with genital herpes 7 years ago, I thought my life was over. Now I am encouraged by the medical research that Facts About Genital Herpes: Genital herpes is one of the most common STDsin the United States. Approximately onein five or about 50 million Americans areinfected with genital herpes. Nearly 90 percent of people infected may not know that they have genital herpes. Anyone whois sexually active with an infected partner can get genital herpes. Womengetgenital herpes more offen than men. is being done on new treatment options to make managing genital herpes more convenient for patients like me,” Ginasaid. Novartis Pharmaceuticals Corporation, the maker of Famvir, 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, Chief Executive Officer, 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 man- ageable for Americans living with this condition.” 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. RGHis caused by the herpes simplex virus (HSV). There are two types of HSV: HSV-1, which causes fever blisters or cold sores, and HSV-2, which causes most cases of RGH. RGH is usually spread by having vaginal, anal or oral sex with a person who has HSV. Anyone who is sexually active with an infected partner can get genital herpes. Moreover, once a person contracts RGH, the virus stays in the bodyforlife. There is no cure for RGH. Pre- scription antiviral treatments are available to help treat RGH outbreaks. The majority of RGH patients receive episodic therapy, which requires patients to take medication in the event of an outbreak, over the course of three or five days. Patients can also be treated suppressively with daily therapy. Common symptoms of an RGH outbreak can include itching, pain, burning, tingling and tenderness in patients with lesions. Symptomssuch as discharge from the penis or vagina, burning and/or pain when urinatingorflulike symptoms are also common among RGHpatients. Note to Editors: For more information about genital herpes, go to www.genitalherpes.com. Famvir (famciclovir) tablets are indicated for the treatment or suppression of recurrent genital herpes in immunocompetent patients; the treatment of recurrent mucocutaneous herpes sim- plex infections in HIV-infected patients; and the treatment of acute herpes zoster (shingles). In clinical trials, the most commonly reported adverse events vs. placebo were headache (zoster: 22.7% us. 17.8%; episodic: 23.6% vs. 16.4%; suppression: 39.3% vs. 42.9%); nausea (zoster: 12.5% vs. 11.6%; episodic: 10.0% vs. 8.0%); and diarrhea (zoster: 7.7% vs. 4.8%; suppression: 9.0% vs. 9.5%). The efficacy of Famvir has not been established for initial-episode genital herpes infection, ophthalmic zoster, disseminated zoster, or in immunocompromised patients with herpes zoster. The safety and efficacy of Famvir for suppressive therapy have not been established beyond one year. There is no cure for genital herpes. There is no evidence that Famvir can stop the spread of herpes to others. Famvir, Pregnancy Category B, is contraindicated in patients with known hypersensitivity to the product, its components, or Denavir (penciclovir cream). See the full Prescribing Information at www.famvir.com for more information about Famvir.
