Consensus interferon and ribavirin for patients with chronic hepatitis C and failure of previous interferon-α therapy

Background: The efficacy of consensus interferon (CIFN), a synthetic IFN with optimised in vitro activity, was assessed in chronic hepatitis C virus (HCV) patients who had failed the pretreatment with interferon-alpha (IFN alpha) and ribavirin. Methods: One hundred and three patients after non-response (n = 69) or relapse (n = 34) to IFN alpha+/-ribavirin were randomly assigned to high-dose induction (CIFN 27 -> 9 mu g daily for 24 weeks, 9 mu g t.i.w. for 24 weeks) or low-dose treatment (CIFN 18 mg t.i.w. for 12 weeks, 9 mg t.i.w. for 36 weeks); each with ribavirin 800 mg/day. Follow-up was 24 weeks. Results: Non-responder patients treated with high-dose induction had higher early virological response rates (63% vs. 39%, P < 0.05). This initial positive effect was lost during the last 24 weeks of treatment yielding sustained virological response (SVR) rates of 26% in both groups. Relapse patients revealed SVR in 70% and 38% in groups A and B (NS). Treatment was well tolerated with side effect-related preterm discontinuations in 8% and 5%. Conclusions: CIFN and ribavirin treatment induced considerable SVR rates in patients with non-response or relapse to IFN alpha+/-ribavirin. Viral elimination rates might be further increased by continuous daily administration of CIFN and weight-adjusted ribavirin dosing.