Peginterferon alpha-2a (40 KD) plus ribavirin for the treatment of chronic hepatitis C in Japanese patients

• Published in: Journal of gastroenterology and hepatology 2007-05, Vol.22 (5), p.645-652
• Main Authors: Kuboki, Makoto, Iino, Shiro, Okuno, Tadao, Omata, Masao, Kiyosawa, Kendo, Kumada, Hiromitsu, Hayashi, Norio, Sakai, Takahiro
• Format: Article
• Language: English
• Subjects: Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; DNA, Viral - blood; Double-Blind Method; Drug Therapy, Combination; Female; Genotype; Hepacivirus - drug effects; Hepacivirus - genetics; Hepatitis C virus; Hepatitis C, Chronic - diagnosis; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - genetics; Humans; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Japan; Male; Middle Aged; Polyethylene Glycols - adverse effects; Polyethylene Glycols - therapeutic use; Recombinant Proteins; Ribavirin - adverse effects; Ribavirin - therapeutic use; RNA, Viral - blood; Treatment Outcome; Viral Load
• ISSN: 0815-9319; 1440-1746
• DOI: 10.1111/j.1440-1746.2007.04834.x

The efficacy and safety of peginterferon alpha-2a (40 KD) (peg-IFNalpha-2a) plus ribavirin has not been reported for Japanese patients with chronic hepatitis C. The aim of this study was to evaluate this combination in treatment-naïve patients and in non-responders or relapsers to interferon monotherapy. Overall, 201 treatment-naïve patients with hepatitis C virus (HCV) genotype-1b were randomly assigned to 180 microg peg-IFNalpha-2a once-weekly plus ribavirin 600-1000 mg/day or peg-IFNalpha-2a plus placebo for 48 weeks. Additionally, peg-IFNalpha-2a plus ribavirin was administered for 48 weeks to 100 non-responders or relapsers (85% genotype-1) to previous interferon monotherapy. A sustained virological response (SVR) was attained among significantly more treatment-naïve patients receiving combination therapy than monotherapy (61% vs 26%, P < 0.001). For patients with high baseline HCV RNA, the SVR rate was 59% with peg-IFNalpha-2a plus ribavirin versus 24% with peg-IFNalpha-2a monotherapy. Among non-responders or relapsers to previous interferon monotherapy, 54% attained an SVR. Adverse events were generally mild, and discontinuations rates due to adverse events or laboratory abnormalities were low. In Japanese patients, peg-IFNalpha-2a plus ribavirin provided significant improvement in SVR rates compared with peg-IFNalpha-2a alone in treatment-naïve patients, and was effective as re-treatment for non-responders or relapsers to previous treatment with interferon monotherapy.