Document Detail

Peginterferon alpha-2a (40 KD) plus ribavirin for the treatment of chronic hepatitis C in Japanese patients.
MedLine Citation:
PMID:  17444850     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
Makoto Kuboki; Shiro Iino; Tadao Okuno; Masao Omata; Kendo Kiyosawa; Hiromitsu Kumada; Norio Hayashi; Takahiro Sakai
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of gastroenterology and hepatology     Volume:  22     ISSN:  0815-9319     ISO Abbreviation:  J. Gastroenterol. Hepatol.     Publication Date:  2007 May 
Date Detail:
Created Date:  2007-04-20     Completed Date:  2007-07-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8607909     Medline TA:  J Gastroenterol Hepatol     Country:  Australia    
Other Details:
Languages:  eng     Pagination:  645-52     Citation Subset:  IM    
Division of Hepatology, Kawasaki Medical School, Okayama, Japan.
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MeSH Terms
Antiviral Agents / adverse effects,  therapeutic use*
DNA, Viral / blood
Double-Blind Method
Drug Therapy, Combination
Hepacivirus / drug effects*,  genetics
Hepatitis C, Chronic / diagnosis,  drug therapy*,  genetics
Interferon Alfa-2a / adverse effects,  therapeutic use*
Middle Aged
Polyethylene Glycols / adverse effects,  therapeutic use*
RNA, Viral / blood
Ribavirin / adverse effects,  therapeutic use*
Treatment Outcome
Viral Load
Reg. No./Substance:
0/Antiviral Agents; 0/DNA, Viral; 0/Polyethylene Glycols; 0/RNA, Viral; 0/peginterferon alfa-2a; 36791-04-5/Ribavirin; 76543-88-9/Interferon Alfa-2a
Erratum In:
J Gastroenterol Hepatol. 2007 May;22(5):768

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