was jailed for aggressive behavior

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Study Conduct: All 64 subjects who were enrolled in 195-060 advanced to 195140. Fifty-four subjects completed 195-140. The reasons for discontinuation were as follows. One subject (0.035 pg/kg peg-interferon) was lost to follow-up, four (0.1 pg/kg) and three (0.25 pg/kg peg-interferon) subjects were treatment failures, one subject (0.25 pg/kg peg-interferon) did not wish to continue, and one subject (interferon alfa-2b) was jailed for aggressive behavior. Drug Substance: PEG-lntronTM, peg-interferon alfa-2b, is a covalent conjugate of

recombinant interferon alfa-2b with monomethoxy polyethylene glycol product. The biological activity of peg-interferon alfa-2b is derived from its interferon alfa-2b moiety. Interferon alfa-2b has been classified as an alpha interferon and is a water- soluble protein with a molecular weight of approximately 19,000 daltons produced by recombinant DNA techniques.

Interferon alfa-2b is obtained from the bacterial fermentation of a strain of Escherichia co/i bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes. The average molecular weight of the PEG-Intron molecule is approximately 31,000 daltons. Renal elimination accounts for approximately 30% of the clearance. Single-dose PEG-lntron pharmacokinetics following a subcutaneous 1 .O pg/kg dose suggest the clearance of PEG-lntron is reduced in patients with impaired renal function (creatinine clearance c 50 ml/minute). Pharmacokinetic evaluations for pediatric subjects have not been performed. There were

no significant pharmacokinetic differences between male and female patients with chronic hepatitis C. 3 Chronic Viral H Conclusions: The reported frequency of adverse events for peg-interferon alfa-2b and interferon alfa-2b were similar. Pegylated interferon alfa-2b has reduced clearance relative to non-pegylated interferon permitting

reduced dosing frequency at doses that appear to be pharmacologically active. http://www.interferon.ws/pdf/PegIntReview_fda.pdf