Efficacy and safety of pegylated interferon α-2b injection (Y shape, 40 kD) in treatment of patients with genotype 1/6 chronic hepatitis C

• Published in: Zhonghua gan zang bing za zhi Vol. 25; no. 3; p. 187
• Main Authors: Feng, B, Shang, J, Wu, S H, Chen, H, Han, Y, Li, Y Q, Zhang, D Z, Zhao, L F, Wei, S F, Mao, Q, Yin, C B, Han, T, Wang, M R, Chen, S J, Li, J, Xie, Q, Zhen, Z, Gao, Z L, Zhang, Y X, Gong, G Z, Yang, D L, Pan, C, Sheng, J F, Tang, H, Ning, Q, Shi, G F, Niu, J Q, Luo, G H, Sun, Y T, You, H, Wang, G Q, Zhang, L L, Peng, J, Zhang, Q, Liu, J J, Chen, C W, Chen, X Y, Zhao, W, Wang, R H, Sun, L, Wei, L
• Format: Journal Article
• Language: Chinese
• Published: China 20-03-2017
• Subjects: Adult; Antiviral Agents - therapeutic use; Drug Therapy, Combination; Female; Genotype; Hepacivirus - drug effects; Hepacivirus - genetics; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Interferon-alpha - therapeutic use; Male; Middle Aged; Polyethylene Glycols - therapeutic use; Real-Time Polymerase Chain Reaction; Recombinant Proteins - therapeutic use; Ribavirin - therapeutic use; Sustained Virologic Response; Treatment Outcome; Viral Load - drug effects; Hepatitis C, chronic; Interferons; Clinical trial
• ISSN: 1007-3418
• DOI: 10.3760/cma.j.issn.1007-3418.2017.03.006

To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control.
A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), a