Reinforced interferon alpha-2b and ribavirin is more effective than standard combination therapy in the retreatment of chronic hepatitis C previously nonresponsive to interferon: a randomized trial

• Published in: Journal of viral hepatitis 2003-05, Vol.10 (3), p.197-204
• Main Authors: Poynard, T., Marcellin, P., Bissery, A., Myers, R. P., Moussalli, J., Degos, F., Dhumeaux, D., Riachi, G., Bronowicki, J. P., Brissot, P., Buffet, C., Serfaty, L., Naveau, S., Sogni, P., Beaugrand, M., Gayno, S., Larrey, D., Samuel, D., Eugene, C., Pol, S., Bedossa, P., Daurat, V., Chaumet-Riffaud, P.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; adverse events; Aged; Antiviral Agents - administration & dosage; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Drug Therapy, Combination; Female; HCV; Hepacivirus - drug effects; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - virology; Humans; Interferon; Interferon-alpha - administration & dosage; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Male; Middle Aged; nonresponder; Recombinant Proteins; Retreatment; ribavirin; Ribavirin - administration & dosage; Ribavirin - adverse effects; Ribavirin - therapeutic use; RNA, Viral - blood; Treatment Outcome
• ISSN: 1352-0504; 1365-2893
• DOI: 10.1046/j.1365-2893.2003.00427.x

Interferon‐alpha (IFN) monotherapy results in sustained virological clearance in a minority of patients with chronic hepatitis C. The aim of this study was to assess the effect of a reinforced regimen combining ribavirin and high‐dose IFN for 48 weeks compared with a nonreinforced regimen combining a standard IFN regimen and ribavirin for 24 weeks in nonresponders with chronic hepatitis C. A total of 231 patients with chronic hepatitis C and previous nonresponse to IFN monotherapy were randomized. The reinforced group (n = 114) received IFN‐2b 6 million units (MU) thrice weekly (TIW) and ribavirin for 48 weeks, and the nonreinforced group (n = 117) received IFN‐2b 3 MU TIW and ribavirin for 24 weeks. The main outcome measure was a sustained virological response, defined as negative serum hepatitis C virus (HCV)‐RNA 24 weeks following the end of treatment. This endpoint was determined in 98 patients of the reinforced group and 105 patients of the nonreinforced group. At the end of follow‐up, a sustained virological response was observed in 29 of the 98 patients (29.6%) in the reinforced group vs 16 of the 105 patients (15.2%) in the nonreinforced group (P = 0.014). In multivariate analysis, factors associated with a sustained virological response were treated with a reinforced regimen [odds ratio (OR) 2.9; P = 0.06] and genotype 2 or 3 (OR 8.8; P