Background/Aims: The aim of the present, open-labeled, randomized study was to determine the efficacy and safety of different doses of consensus interferon plus ribavirin in the initial treatment of chronic hepatitis C. Methods: One hundred and one genotype 2/3 patients were randomized to receive 9 mcg (group A, n 5 48) or 18 mcg (group B, n 5 53) of consensus interferon thrice weekly plus ribavirin (1000/1200 mg/daily) for 24 weeks and 92 genotype 1 patients to receive 9 mcg (group C, n 5 47) or 18mcg (group D, n 5 45) of consensus interferon plus ribavirin for 48 weeks. Results: In an intention-to-treat analysis, the sustained virologic response at 24-week follow-up was 69% and 66% for group A and B (P 5 0:77) and 40% and 36% for group C and D (P 5 0:63). The overall sustained response was 67% and 38%in patients with genotype 2/3 and 1, respectively.Among genotype 1 patients the sustained virologic response was39% and 41% for high or low baseline viremia levels. Conclusions: Higher consensus interferon dose does not increase sustained virologic response. Naive genotype 1 patients mayachieve significant response rate of approximately40%if treated with 9 mcg of consensus interferon plus ribavirin for 48 weeks.
A randomized trial of consensus interferon in combination with ribavirin as initial treatment for chronic hepatitis C.
FATTOVICH, Giovanna;ZAGNI, Irene;
2003-01-01
Abstract
Background/Aims: The aim of the present, open-labeled, randomized study was to determine the efficacy and safety of different doses of consensus interferon plus ribavirin in the initial treatment of chronic hepatitis C. Methods: One hundred and one genotype 2/3 patients were randomized to receive 9 mcg (group A, n 5 48) or 18 mcg (group B, n 5 53) of consensus interferon thrice weekly plus ribavirin (1000/1200 mg/daily) for 24 weeks and 92 genotype 1 patients to receive 9 mcg (group C, n 5 47) or 18mcg (group D, n 5 45) of consensus interferon plus ribavirin for 48 weeks. Results: In an intention-to-treat analysis, the sustained virologic response at 24-week follow-up was 69% and 66% for group A and B (P 5 0:77) and 40% and 36% for group C and D (P 5 0:63). The overall sustained response was 67% and 38%in patients with genotype 2/3 and 1, respectively.Among genotype 1 patients the sustained virologic response was39% and 41% for high or low baseline viremia levels. Conclusions: Higher consensus interferon dose does not increase sustained virologic response. Naive genotype 1 patients mayachieve significant response rate of approximately40%if treated with 9 mcg of consensus interferon plus ribavirin for 48 weeks.
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