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| |  FDA Approves Famvir For Treatment Of Herpes In People With HIV PHILADELPHIA, PA -- June 17, 1998 -- The United States Food and Drug Administration has approved SmithKline Beecham’s Famvir(R) (famciclovir) for the treatment of recurrent herpes simplex virus infections (genital herpes and cold sores) in HIV-infected individuals. Famvir is the first and only oral drug approved for the treatment of herpes infections in people with HIV. Nearly all people with HIV (95 percent) are infected with either HSV-1, HSV-2, or both and studies suggest that genital herpes is a major co-factor in the spread of HIV. "An effective antiviral treatment that can be used safely in HIV patients is good news, because herpes infections are very common among people with HIV and outbreaks are often more frequent and severe," said lead investigator Barbara Romanowski, M.D., clinical professor, division of medical microbiology and immunology, University of 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 treating people with HIV." Herpes infections are one of the most commonly diagnosed infections among the HIV/AIDS population. Almost all HIV-infected individuals (95 percent) are infected with HSV-1 and/or HSV-2, which cause cold sores and genital herpes. Herpes infections are often more painful and produce more necrosis (tissue damage) in HIV-infected individuals than in otherwise healthy adults. Outbreaks are more severe and frequent, and the virus can spread to other parts of the body such as the liver or lungs, causing potentially life-threatening complications. In addition, open lesions often formed during herpes outbreaks can facilitate the transmission of HIV. This new indication was based on results from a double-blind, multicentre study in which 293 HIV-infected patients with recurrent genital herpes or cold sores were treated within 48 hours of lesion onset with either Famvir 500 mg twice daily or a high dose of acyclovir 400 mg five times daily for seven days. Approximately 40 percent of patients had CD4 counts below 200 cells/mm3. Famvir was effective in healing herpes lesions and reducing new lesion formation. "Since people with HIV are typically taking large amounts of medications that require frequent dosing, compliance is a common problem,” said Sorana Segal-Maurer, M.D., an attending physician at New York Hospital Medical Center of Queens, who specialises in the treatment of people with HIV. “The fact that Famvir needs to be taken only twice daily is significant, given the fact that missing even one or two pills on a more frequent regimen may compromise the overall effectiveness of a patient's treatment," Famvir, which is the oral form of penciclovir, is rapidly absorbed into the bloodstream, providing 77 percent bioavailability. In addition, Famvir has a long intracellular half-life in infected cells in-vitro which may be responsible for its convenient twice-daily dosing. Famvir was generally well tolerated. The most commonly reported side effects were headache and nausea. Famvir is also approved for the treatment or suppression of recurrent genital herpes and the treatment of herpes zoster in immunocompetent individuals. More information on: Famvir, SmithKline Beecham
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