Interferon-ribavirin for chronic hepatitis C with and without cirrhosis: Analysis of individual patient data of six controlled trials

Background & Aims: The aim of this study was to compare interferon (IFN)-ri bavirin combination therapy with IFN monotherapy in chronic hepatitis C wit h particular focus on its efficacy in cirrhosis. Methods: A multivariate an alysis of individual patient data of all randomized controlled trials using an IFN-ribavirin arm, reported between 1991 and March 1998, was performed. Centers included 1 Asian and 5 European university-based referral centers for liver disease. A total of 197 patients with chronic hepatitis C receive d IFN-alpha (3 MU three times weekly) and ribavirin (1-1.2 g daily) for 6 m onths, and 147 patients received IFN-alpha (3 MU three times weekly) for 6 months. Patients were characterized according to previous IFN therapy, pres ence of cirrhosis, and genotype 1. Efficacy of therapy was evaluated by ass essing the sustained response rate by logistic regression analysis. Results : Patients without cirrhosis treated with IFN-ribavirin had a significantly higher sustained response rate than those treated with IFN, approximately 3-fold for previously untreated patients (IFN-ribavirin: genotype 1, 33%; g enotype 2/3, 65%; IFN: genotype 1, 8%; genotype 2/3, 24%). In cirrhosis, su stained response rates with IFN-ribavirin (previously untreated: genotype 1 , 7%; genotype 2/3, 24%) were also significantly higher than those with IFN (previously untreated: genotype 1, 1%; genotype 2/3, 5%). Clinical relevan t superiority of combination therapy over IFN monotherapy was also observed for relapse; the same trend was observed for nonresponders. Tolerance for IFN-ribavirin was similar for patients with or without cirrhosis. Conclusio ns: Combination with ribavirin significantly enhances the sustained respons e rate of IFN therapy in major patient types (cirrhosis, genotype 1) with c hronic hepatitis C. Thus, IFN-ribavirin combination is likely to become the antiviral therapy of choice for cirrhosis caused by hepatitis C.