Korean J Hepatol.  2010 Mar;16(1):38-48. 10.3350/kjhep.2010.16.1.38.

Clinical efficacy and safety of the combination therapy of peginterferon alpha and ribavirin in cirrhotic patients with HCV infection

• Cheong HR
• Woo HY
• Heo J
• Yoon KT
• Kim DU
• Kim GH
• Kang DH
• Song GA
• Cho M

• KMID: 1782219
• DOI: http://doi.org/10.3350/kjhep.2010.16.1.38

Abstract

BACKGROUND/AIMS
The combination therapy of peginterferon (PEG-IFN) and ribavirin is the standard treatment for hepatitis C virus (HCV) infection. However, few trials have involved patients with cirrhosis. The purpose of this study was to elucidate the efficacy and safety of treatment with PEG-IFN and ribavirin in patients with cirrhosis associated with HCV infection. METHOD: A total of 65 patients were treated with PEG-IFN alpha-2a/ribavirin (n=32) or PEG-IFN alpha-2b/ribavirin (n=33). PEG-IFN alpha-2a and PEG-IFN alpha-2b were administered at doses of 180 microg/week and 1.5 microg/kg/week, respectively, and ribavirin was administered orally at doses of 800-200 mg. Patients with HCV genotype 1 and genotype non-1 were treated for 48 and 24 weeks, respectively. The treatment response was assessed based on the sustained virologic response (SVR).
RESULTS
The early virologic response (EVR), end-of-treatment response (ETR), and SVR were 70.0%, 52.0%, and 24.0%, respectively, in genotype 1 (n=50). In genotype non-1 (n=15), the ETR was 53.3% and the SVR was 33.3%. The overall SVR did not differ with genotype (1 vs non-1, 24.0% vs. 33.3%; P=0.471) or between decompensated cirrhosis and compensated cirrhosis (20.0% vs. 27.3%, P=0.630). Ten patients developed cirrhotic complications during the treatment, and 11 stopped treatment due to treatment-related adverse events.
CONCLUSION
The combination therapy of PEG-IFN and ribavirin exhibited a low efficacy in cirrhotic patients with HCV infection and was associated with frequent serious complications. However, with careful management of complications, the therapy may have a considerable efficacy in some patients with cirrhosis and HCV infection.

Keyword

Chronic hepatitis C; Peginterferon; Ribavirin; Liver cirrhosis; Combination therapy

MeSH Terms

Aged
Antiviral Agents/adverse effects/*therapeutic use
Drug Therapy, Combination
Female
Genotype
Hepatitis C, Chronic/complications/*drug therapy
Humans
Interferon Alfa-2a/adverse effects/*therapeutic use
Interferon Alfa-2b/adverse effects/*therapeutic use
Liver Cirrhosis/*complications
Male
Middle Aged
Neutropenia/etiology
Platelet Count
Polyethylene Glycols/adverse effects/*therapeutic use
RNA, Viral/blood
Retrospective Studies
Ribavirin/adverse effects/*therapeutic use
Severity of Illness Index
Treatment Outcome