Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Tuesday, 8 October 1996
"HIV-infected individuals are known to experience frequent and troublesome genital herpes outbreaks," said Dr. Timothy V. Schacker formerly of the University of Washington and first author of the study. "Based on the results of this study, famciclovir is a well-tolerated and effective drug for suppression of HSV-2 in HIV-infected individuals."
This randomized, double-blind placebo-controlled study was conducted with 48 individuals infected with HIV and HSV. Using a crossover study design, patients were randomized to receive famciclovir (500 mg, twice daily) for eight weeks, followed by a seven-day washout period and then eight weeks of placebo. Similarly, patients who were initially randomized to receive placebo concluded the study with famciclovir treatment (500 mg, twice daily).
In a crossover analysis of patients successfully completing both arms of the study, famciclovir-treated patients experienced a significantly lower overall rate of HSV-2 shedding versus placebo (1.3 vs. 9.7 percent of days, respectively). The subc1inical anogenital HSV-2 shedding rate (percentage days with positive culture and no lesions present) was also significantly lower in the famciclovir group (1.2 percent) than in the placebo group (6.3 percent). Furthermore, the percentage of days that HSV-2 shedding occurred and herpes lesions or symptoms were present was also significantly reduced during famciclovir treatment.
HIV-infected persons experience more frequent and prolonged episodes of anal and genital HSV-2 reactivation. Famciclovir appears effective in reducing the frequency and severity of these HSV reactivations in HIV-infected persons.
Famvir was cleared by the U.S. Food and Drug Administration to treat recurrent genital herpes in immunocompetent patients in December, 1995 and is also currently indicated for the treatment of acute herpes zoster (shingles). Famciclovir is being studied for the treatment of a number of other infections caused by the viruses belonging to the family of human herpesviruses in both immunocompetent and immunocompromised individuals. Studies are also in progress with this agent in the treatment of chronic hepatitis B virus infection.
The study was supported by a clinical grant from SmithKline Beecham Pharmaceuticals.
SOURCE University of Washington
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