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Exp Ther Med. 2017 Jan;13(1):9-16. doi: 10.3892/etm.2016.3914. Epub 2016 Nov 18.

Tolerability and efficacy of pegylated consensus interferon-α in the treatment of chronic hepatitis C.

Author information

1
Phase One Clinical Trial Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
2
Department of Hand Surgery, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.
3
Chongqing Fujin Biomedical Co., Ltd., Fujin, Heilongjiang 518051, P.R. China.
4
Department of Clinical Medicine, Jilin University, Changchun, Jilin 130021, P.R. China.
5
Hepatobiliary Medical Ward, First Hospital, Jilin University, Changchun, Jilin 130021, P.R. China.

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.

KEYWORDS:

adverse event; efficacy; recombinant interferon; tolerance

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