Reduced Dose and Duration of Peginterferon alfa-2b and Weight-Based Ribavirin in Patients With Genotype 2 and 3 Chronic Hepatitis C

Journal of Hepatology
PII: S0168-8278(11)00012-2
doi:10.1016/j.jhep.2010.12.024
© 2011 Published by Elsevier Inc.

Articles in Press

Michael Mannsa, Stefan Zeuzemb, Ajit Soodc, Yoav Luried, Markus Cornberga, Hartwig Klinkere, Peter Buggischf, Martin Rössleg, Holger Hinrichsenh, Ismail Mericani, Yaron Ilanj, Stefan Maussk, Saif Abu-Mouchl, Andryes Horbanm, Thomas H. Müllern, Christoph Welschb, Rongdean Cheno, Rab Faruqio, Lisa D. Pediconeo, Heiner Wedemeyera

Received 4 May 2010; received in revised form 3 December 2010; accepted 13 December 2010. published online 14 January 2011.
Accepted Manuscript

Abstract

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 μg/kg/wk) for 24 weeks (group A); peginterferon alfa-2b (1.0 μg/kg/wk) for 24 weeks (group B); or peginterferon alfa-2b (1.5 μg/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 μg/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.

Source