Efficacy of interferon alpha-2b induction therapy before retreatment for chronic hepatitis C

Background/Aims: Chronic hepatitis C (HCV) patients who have failed previous treatment have low sustained viral response (SVR) rates with repeat treatment. We evaluated whether interferon (IFN) induction during retreatment improves response rates. Methods: Two randomized, controlled trials were conducted in chronic HCV patients who failed IFN. In Study 1, patients received IFN 3MU daily plus ribavirin (RBV) 1000 mg/ day for 4 weeks, followed by IFN 3MU TIW plus RBV 1000 mg/ day for 44 weeks ( induction; n = 232), or IFN 3MU TIW plus RBV 1000 mg/ day for 48 weeks (non-induction; n = 237). In Study 2, patients received IFN 5MU B. I. D. plus RBV 1000-1200 mg/ day for 2 weeks, followed by pegylated IFN (PEG-IFN) 75-150 mu g weekly plus RBV 1000-1200 mg/ day for 46 weeks ( induction; n = 201), or PEG-IFN 75-150 mu g weekly plus RBV 1000-1200 mu g/day for 48 weeks (non-induction; n = 206). The primary end point for both trials was SVR. Results: Induction did not increase SVR compared with non-induction, but did increase the on-treatment response among genotype non-1 patients in Study 2. By intention-to-treat (ITT) analysis, SVR in Study 1 was 13% for induction vs. 9% for non-induction (P = NS). In Study 2 ( ITT), SVR was 20% for induction vs. 24% for non-induction ( P = NS). However, by non-ITT analysis of Study 2, genotype non-1-previous non-responders showed significantly higher response rates with induction than non-induction. Conclusion: For chronic HCV patients who have failed IFN, induction with retreatment does not improve SVR, but may be beneficial for patients with genotype non-1 HCV.