Pegylated Interferon Monotherapy for Chronic Hepatitis C

Interferon (IFN) α-2a has been attached to a branched 40-kD PEG molecule and IFN α-2b to a linear 12-kD PEG molecule leading to elimination half-lives of approximately 75 and approximately 30 hours, respectively. In one pivotal trial, 531 patients with chronic hepatitis C were assigned to receive either 180 μg of pegylated IFN α-2a once weekly for 48 weeks or 3 × 6 mIU standard IFN for 12 weeks, followed by 3 × 3 mIU for 36 weeks. Sustained virological response rates were 39 and 19% for pegylated and standard IFN α-2a, respectively. In a second trial in patients with hepatitis C virus (HCV)-associated cirrhosis and bridging fibrosis, sustained virological response rates were 8% (3 × 3 mIU IFN three times a week), 15% (90 μg PEG-IFN α-2a four times a week), and 30% (180 μg PEG-IFNα-2a four times a week). In a third trial, 1219 patients with chronic hepatitis C were randomly assigned to receive either standard IFN α-2b (3 × 3 mIU) or once weekly pegylated IFN α-2b (0.5, 1.0, or 1.5 μg/kg). Sustained virological response rates were highest in the 1.0 μg/kg dose and achieved 25% compared with 12% in the standard IFN group. In conclusion, each regimen of pegylated IFN given once weekly is more effective than a regimen of standard IFN given three times weekly.

KEYWORDS

Hepatitis C virus - pegylated interferon alfa-2a (40 kD) - pegylated interferon alfa-2b - standard interferon - monotherapy - histology - viral kinetics - virological response

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