Background and Aims: Consensus interferon (CIFN) is a newly developed type
I interferon. The aim of this study was to investigate the safety and effic
acy of CIFN in the treatment of patients with chronic hepatitis C and to de
termine the predictors for sustained response.
Methods: Patients were randomized to receive 3 mug or 9 mug CIFN three time
s a week for 24 weeks, followed by 24 weeks of observation. Efficacy was as
sessed by normalization of serum transaminase levels and disappearance of s
erum hepatitis C virus (HCV)-RNA at the end of treatment and at 24 weeks af
ter stopping treatment. Histologic response was defined as a decrease of at
least two points in the Knodell necroinflammatory score at week 48 and was
compared with baseline.
Results:There were no serious adverse effects related to CIFN therapy. Over
all, 44% of patients receiving 3 mug and 48% of patients receiving 9 mug ha
d normalization of serum transaminase levels and disappearance of HCV virem
ia at the end of treatment. At 24 weeks after stopping treatment, 16% of pa
tients in receiving 9 mug and 12% of patients receiving 3 mug had sustained
responses. The histologic responses in patients receiving 9 mug and those
receiving 3 mug were 60% and 36%, respectively. The necroinflammatory score
was significantly reduced from baseline to week 48 in both groups. In addi
tion, bodyweight < 60 kg and pretreatment serum HCV-RNA level < 0.5 MEq/mL
can serve as predictors for sustained response to CIFN treatment.
Conclusions: These findings suggest that 9 mug CIFN is safe and effective i
n the treatment of patients with chronic hepatitis C. (C) 2000 Blackwell Sc
ience Asia Pty Ltd.