Interferon versus ribavirin plus interferon in chronic hepatitis C previously resistant to interferon: a randomized trial

Background: More than 70% of patients with chronic hepatitis C are resistan t to interferon therapy. Ribavirin, in association with interferon, has bee n demonstrated as effective, at a dose of 800-1200 mg/day, but the efficacy of a lower dose has not been established. Methods: We assessed the effecti veness of the combination of 600 mg/day of ribavirin plus 3 MU of interfero n over a period of 6 months, in a group of patients previously resistant to interferon. Sixty-two patients with chronic hepatitis C with serum and hep atic HCV RNA relapsers or non-responders to interferon, were randomly divid ed into two groups: group A received 3 MU of interferon alpha-2b, three tim es a week for 6 months; group B was given the same dose plus 600 mg per day of ribavirin for 6 months. Two patients from each group dropped from thera py. One patient from group A and two from group B withdrew from treatment b ecause of adverse effects. Results: Mean alanine aminotransferase levels we re similar in both groups throughout the study. A sustained response was ob served in 7% and 7.4% of groups A and B with short-term response in 39% and 59%, and no response in 54% and 34% from both groups respectively (nonsign ificant). At 12 months, 4 and 7 patients from groups A and B respectively, cleared serum HCV RNA however, only one sustained responder from each group cleared HCV RNA from peripheral blood mononuclear cells. At 18 months, 3 p atients remained serum HCV RNA negative. Adverse effects were similar. Only haemoglobin values were lower in group B in the first month of therapy (p< 0.05). Conclusion: In conclusion, the combination of 3 MU of interferon plu s 600 mg of ribavirin is not effective in chronic hepatitis C resistant to interferon.