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| |  Famvir Safe and Effective in Treating In HIV-Infected Patients WASHINGTON, Jan. 24, 1997 -- In interim results from a study presented today, Famvir (famciclovir, SmithKline Beecham) was safe and effective in treating shingles (acute herpes zoster) in HIV-infected patients. Famvir halted the progression of shingles, relieved pain, and accelerated healing in the majority of patients who received treatment within three days of lesion onset. The results were presented by Daniel Skiest, M.D., at the Fourth Conference on Retroviruses and Opportunistic Infections in Washington, D.C. "A safe and effective treatment option for HIV-infected individuals with shingles is good news for patients," said Dr. Daniel Skiest, assistant professor of internal medicine, division of infectious diseases, The University of Texas Southwestern Medical Center at Dallas. "Since traditional therapy must be taken five times daily, treating patients with Famvir may help increase compliance. Famvir offers the most convenient dosing schedule for this patient population." Shingles is a viral disease caused by the varicella zoster virus (VZV), the same virus that causes chicken pox, and is characterized by an outbreak of painful and itchy blister-like sores which may last up to six weeks. Shingles, which affects an estimated 850,000 Americans each year, is eight times more likely to develop in HIV-infected patients than in the general population and can lead to increased morbidity. In immunocompromised patients, the virus can spread by dissemination to other parts of the body such as the liver or lungs which is potentially life threatening. In this ongoing, multicenter, open-label study, an analysis was conducted of 15 HIV-infected patients (seven males, eight females) with shingles who received Famvir 500 mg three times daily for seven days within 72 hours of lesion onset. To evaluate the effects of Famvir on a shingles episode, the investigators observed the changes in the course of an episode over one month. At each visit, the lesion stages (papules, blisters, ulcers, crusts) were recorded. By the fourth day, blister formation had ceased in 67 percent of patients and in 100 percent of patients by the seventh day. Lesions were fully crusted in 60 percent of patients by the tenth day. Approximately eighty percent of patients reported complete lesion healing by day 28. Famvir was also effective in relieving pain associated with shingles. Fifty-five percent of the patients reported a loss of all pain within four weeks of treatment with Famvir. "One of the common complaints of HIV-infected patients with shingles is pain associated with outbreaks. Since shingles tends to be more severe and recurrent in this particular patient population, Famvir's ability to relieve pain in more than half of the patients is significant," said Dr. Skiest. These data also suggest that the response to Famvir in HIV-infected individuals with shingles compares favorably to the response previously reported for immunocompetent individuals with shingles who were treated with Famvir. Famvir is the well-absorbed oral form of penciclovir with 77 percent bioavailability. It is a potent antiviral agent that is highly selective for members of the herpes virus family, including the shingles virus. In addition, Famvir has a long intracellular half-life in infected cells in vitro which allows for persistent antiviral activity. Famvir, in its active form as penciclovir, has been shown to have a half-life of 10-20 hours in herpesvirus infected cells in vitro versus one hour or less for acyclovir. Famvir is currently indicated for the treatment of recurrent genital herpes and acute herpes zoster (shingles) in immunocompetent individuals. It is being studied for the treatment of a number of infections in immunocompromised individuals. Data previously presented showed that Famvir was safe and effective in preventing recurrent genital herpes in HIV-infected patients. SmithKline Beecham plans to file a supplementary new drug application (SNDA) for Famvir for the treatment of acute herpes zoster and recurrent genital herpes in immunocompromised individuals later this year.
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