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

Abstract:

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.

authors

Kuboki M,Iino S,Okuno T,Omata M,Kiyosawa K,Kumada H,Hayashi N,Sakai T

doi

10.1111/j.1440-1746.2007.04834.x

subject

Has Abstract

pub_date

2007-05-01 00:00:00

pages

645-52

issue

5

eissn

0815-9319

issn

1440-1746

pii

JGH4834

journal_volume

22

pub_type

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