title: Tolerability and efficacy of pegylated consensus interferon-α in the treatment of chronic hepatitis C.
abstract: This study aimed to explore and evaluate the tolerability and antiviral activity of pegylated recombinant human consensus interferon-α (PEG-CIFN) in adults with hepatitis C virus (HCV) infection. A total of 48 adult subjects chronically infected with HCV were divided into five groups, which were treated separately with PEG-CIFN 1.0 µg/kg (n=10), 1.5 µg/kg (n=10), 2.0 µg/kg (n=9) or 3.0 µg/kg (n=10), or pegylated IFN α-2a (Pegasys) 180 µg (n=9) as controls. Symptoms were observed and laboratory results collected to monitor adverse reactions, adjust drug dosage and evaluate tolerability. The thrombocytopenic effects in all PEG-CIFN dose groups were less than that of pegylated IFN α-2a (at week 14, P<0.05). The rapid virologic response of the PEG-CIFN 1.5, 2.0 and 3.0 µg/kg groups and the pegylated IFN α-2a group were significantly higher than that of the PEG-CIFN 1.0 µg/kg group (P<0.05). Patients who had HCV genotype 1b infections had relatively high responses. The early virologic response of the PEG-CIFN 1.0, 1.5 and 2.0 µg/kg groups and the pegylated IFN α-2a group were 30, 90, 88.8 and 88.8% respectively. PEG-CIFN is well tolerated, and was found to have dose-dependent effectiveness in subjects with chronic hepatitis C. Virological response rates between PEG-CIFN 1.5 or 2.0 µg/kg, and pegylated IFNα-2a were similar, and not significantly different. It is concluded that 1.5 µg/kg PEG-CIFN may be the clinically recommended dose. PEG-CIFN is superior to pegylated IFN α-2a in maintaining platelet levels.
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Yan-Hua
authors.initials: YH
authors.lastname: Ding
authors.affiliation: Department of Hand Surgery, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Bin
authors.initials: B
authors.lastname: Liu
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Xin
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Hand Surgery, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Li
authors.initials: L
authors.lastname: Sun
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Hong
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Chongqing Fujin Biomedical Co., Ltd., Fujin, Heilongjiang 518051, P.R. China.
authors.forename: Hua
authors.initials: H
authors.lastname: Luo
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Yan-Fu
authors.initials: YF
authors.lastname: Sun
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Cheng-Jiao
authors.initials: CJ
authors.lastname: Liu
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Qi
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Department of Clinical Medicine, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Yu-Chen
authors.initials: YC
authors.lastname: Cao
authors.affiliation: Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Hong
authors.initials: H
authors.lastname: Chen
authors.affiliation: Hepatobiliary Medical Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
authors.forename: Jun-Qi
authors.initials: JQ
authors.lastname: Niu
keywords: adverse event; efficacy; recombinant interferon; tolerance