To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Famvir Approved In Canada For Herpes Treatment In People With HIV URL: http://www.pslgroup.com/dg/13F7E6.htm Doctor's Guide October 28, 1999
TORONTO, ON -- October 28, 1999 -- Health Canada has approved SmithKline Beecham Pharma's Famvir (famciclovir) for the treatment of recurrent herpes simplex infections (genital herpes and cold sores) in HIV-positive patients. Famvir is the first and only oral therapy approved for the treatment of herpes infections in people with HIV infections.
Nearly all people with HIV (up to 95 per cent) are infected with herpes simplex virus 1, herpes simplex virus 2 or both. Herpes simplex 1 is generally associated with oral ulcers or blisters while herpes simplex 2 causes genital herpes.
Study Determines Famvir Key to Minimizing Outbreaks in HIV Population
In a double-blind multinational study led by Canadian Dr. Barbara Romanowski, HIV patients who were suffering from lesions caused by herpes simplex were treated with Famvir 500 mg twice daily for seven days or high dose acyclovir, 400 mg taken five times a day for seven days. The pivotal study conducted in 48 centres (ten of which were in Canada), and 12 countries concluded that Famvir twice a day was well tolerated and effective in preventing new lesions, reducing symptoms, and stopping viral shedding associated with herpes simplex. Herpes is extremely contagious and is associated with higher risks of transmission and acquisition of HIV.
"An effective antiviral treatment that can be used safely in HIV patients is good news. Herpes infections are very common among people with HIV and outbreaks are often severe and frequent," said Dr. Barbara Romanowski,
Clinical Professor in the Division of Medical Microbiology and Immunology at the University of Alberta in Edmonton, Alberta. "In addition, since HIV may be spread through open herpes lesions, a safe and effective treatment for herpes is an important tool for physicians."
The impact on the quality of life for herpes sufferers with HIV is two-fold. Patients report that the stigma associated with herpes coupled with the pain and frequent recurring outbreaks is virtually unbearable for many individuals.
Symptoms of herpes simplex virus 1 and herpes simplex virus 2 infections typically include sporadic, recurring cold sores on the mouth and or lesions on the genital area. In HIV-infected individuals, herpes outbreaks are more frequent and painful than those in healthy people.
During the first outbreak in immunocompetent patients, a complete episode can last as long as three to four weeks. Some individuals experience as many as 12 outbreaks annually. The herpes virus can also cause more severe infections in HIV-positive patients, affecting the esophagus, liver and lungs and, in some cases, causing death.
"Reducing the infectious period and providing a significantly more convenient dosing regimen will enable people with HIV to take more control over this debilitating disease," said Dr. Romanowski. "Famvir's ability to effectively reduce new lesion formation is very promising considering the potential for transmitting HIV during herpes outbreaks," she added.
In addition to this new indication for the treatment of recurrent herpes simplex infections in HIV-positive patients Famvir is also indicated for the treatment of herpes zoster (shingles), recurrent episodes of genital herpes and for suppression of recurrent episodes of genital herpes in immunocompetent patients.
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