BACKGROUND: There is increasing interest in identifying patients with chronic hepatitis C genotype 2 or 3 infection in whom it is possible to lower the burden of therapy whilst retaining high levels of efficacy.
METHODS: Treatment-naive patients with chronic hepatitis C genotype 2/3 infection were randomised to receive peginterferon alfa-2b (1.5 ?g/kg/wk) for 24 weeks (group A); peginterferon alfa-2b (1.0 ?g/kg/wk) for 24 weeks (group B); or peginterferon alfa-2b (1.5 ?g/kg/wk) for 16 weeks (group C), each in combination with weight-based ribavirin (800-1200 mg/day). The study population comprised 2 cohorts: the Hep-Net cohort enrolled in Germany and an international cohort enrolled at study sites throughout Europe and Asia. The primary end point was sustained virological response (SVR).
RESULTS: The study included 682 patients; 80.2% had genotype 3 infection. In the intent-to-treat population, SVR rates were 66.5%, 64.3%, and 56.6% in groups A, B, and C, and were similar in Asian and white patients. Treatment differences (A vs B and A vs C) failed to reach the predefined margin for noninferiority of -10%; and thus groups B and C failed to show noninferiority relative to group A. Among patients with undetectable HCV RNA at week 4, SVR rates were 75.3%, 75.9% and 72.4%, respectively. Relapse rates were 17.8%, 16.3%, and 29.3%, respectively. Treatment-emergent serious adverse events were highest in group A and lowest in group C, and adverse events leading to discontinuation were similar across treatment arms.
CONCLUSION: For patients with chronic hepatitis C genotype 2/3 infection, 24 weeks of peginterferon alfa-2b (1.5 ?g/kg/wk) plus weight-based ribavirin remains a standard-of-care therapy; however, treatment for 16 weeks may be considered for patients with undetectable HCV RNA at week 4 of treatment.