Induction interferon and ribavirin for re-treatment of chronic hepatitis C patients unresponsive to interferon alone

SUMMARY Background: The optimal treatment for hepatitis C patients unresponsive to interferon is unclear. Highdose induction interferon may enhance early viral clearance, whilst ribavirin reduces relapse; in combination, they may improve sustained virological response rates. Aim: To compare the efficacy and safety of re-treatment with interferon induction, with or without ribavirin, in interferon non-responders. Methods: We randomized 218 biochemical interferon non-responders to 10 MU interferon a2b daily for 4 weeks, followed by 5 MU thrice weekly for 48 weeks plus ribavirin (II + R), or to the same interferon regimen plus placebo (II + P). All patients were viraemic at entry. Results: The sustained virological response in the II + R group was 39% [95% confidence interval (CI), 30–48%], compared with 16% (95% CI, 9–23%) in the II + P group (P < 0.002). The study drug was discontinued for intolerable symptoms during induction in 9% of the II + R group and in 5% of the II + P group. By logistic regression, a sustained virological response was more likely following II + R treatment (odds ratio, 4.4; 95% CI, 2.1–9.7) and less likely in patients with genotype 1 or 4 (odds ratio, 0.16; 95% CI, 0.07–0.36). Conclusion: High-dose induction interferon plus ribavirin is well tolerated and effective for patients unresponsive to interferon alone.