Abstract
Safety reporting from individual ongoing and completed clinical studies has demonstrated that famciclovir, the well-absorbed oral form of the antiherpesvirus agent penciclovir, has been well tolerated by more than 3,000 individuals worldwide. An integrated safety evaluation has been performed and includes over 1,600 patients from 11 completed, randomized, double-blind clinical trials and 2 open trials. The famciclovir population consisted of 816 herpes zoster patients (four trials), 409 patients with acute genital herpesvirus infections (seven trials), and 382 patients from two genital herpes suppression studies. Overall, the famciclovir-treated patient population was 57.7% female and ranged in age from 15 to 102 years (mean, 42.6 years), with 31.2% aged 50 years or more and 15.7% aged 65 years or more. The mean duration of exposure to famciclovir was 28.8 days (5.8 days excluding suppression studies). The total daily doses ranged from 125 mg to 2.25 g. The most common adverse experiences reported as related to study medication (famciclovir and placebo) were headache, nausea, and diarrhea. The frequencies of adverse experiences and laboratory abnormalities (hematology, clinical chemistry, and urinalysis parameters) were similar in both famciclovir and placebo recipients. Thus, safety data from the analysis of 13 completed clinical studies demonstrate that famciclovir is tolerated well by patients with either herpes zoster or genital and has a safety profile comparable to that of placebo.
Highlights
Safety reporting from individual ongoing and completed clinical studies has demonstrated that famciclovir, the well-absorbed oral form of the antiherpesvirus agent penciclovir, has been well tolerated by more than 3,000 individuals worldwide
The minimal phosphorylation of penciclovir in uninfected cells, together with the low activity of penciclovir triphosphate against cellular DNA polymerases, provides a rationale for the lack of toxicity of penciclovir in cell culture
This hypothesis has been tested in a wide range of human cell lines of differing tissue origin [2]. These tests showed that penciclovir is like acyclovir in being exceptionally nontoxic to replicating cells in culture
Summary
Received 2 February 1994/Returned for modification 9 May 1994/Accepted 2 August 1994. Safety reporting from individual ongoing and completed clinical studies has demonstrated that famciclovir, the well-absorbed oral form of the antiherpesvirus agent penciclovir, has been well tolerated by more than 3,000 individuals worldwide. An integrated safety evaluation has been performed and includes over 1,600 patients from 11 completed, randomized, double-blind clinical trials and 2 open trials. Safety data from the analysis of 13 completed clinical studies demonstrate that famciclovir is tolerated well by patients with either herpes zoster or genital herpes and has a safety profile comparable to that of placebo. This report presents details of an integrated safety analysis covering 1,607 patients from 11 completed, randomized, double-blind clinical trails and two open studies. The safety of famciclovir was assessed in clinical studies of immunocompetent, adult patients with herpes zoster and genital herpes by recording adverse experiences and monitoring laboratory parameters.
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