Pegylated interferon and ribavirin in re-treatment of responder-relapser HCV patients

BackgroundThe re-treatment of patients who relapse after a course of standard interferon and ribavirin with pegylated interferon alfa-2b plus ribavirin is an open issue.AimsTo evaluate efficacy and safety of treatment with pegylated interferon alfa-2b plus ribavirin and the role of early HCV-RNA assessment as a predictor of sustained response.PatientsBetween May 2001 and December 2002, 242 consecutive patients with chronic hepatitis C were enrolled in an open, regional, multicentre study. Seventy-eight of them were responder-relapsers to a previous course of combination therapy.MethodsPatients were treated with pegylated interferon alfa-2b (1 μg/kg/week) plus ribavirin (800–1200 mg daily). Qualitative HCV-RNA was performed at week 2. Genotypes 1–4 were treated for 48 weeks, while genotypes 2 and 3 were treated for 24 weeks.ResultsWe obtained an overall sustained virological response rate of 41.0% (78.6% for patients with genotypes 2–3).ConclusionThis treatment schedule prove to be safe and effective in relapsers with genotype non-1 while genotype 1–4 patients had a low rate of sustained virological response. Qualitative virological assessment after 2 weeks may identify patients who are more likely to reach sustained virological response, but it is not a valid tool for a stopping rule approach.