Background. Interferon α with ribavirin combination therapy is effective but still unsatisfactory in the treatment of patients with interferon-relapsed chronic hepatitis C. Aims. To compare, in a randomized, double blind, placebo-controlled study, high-dose interferon-α2b with or without ribavirin in the treatment for interferon-relapsers. Patients. A total of 52 patients with interferon-relapsed chronic hepatitis C were randomly assigned to receive 24-week treatment with interferon-α2b (6 MU three times per week) combined with either ribavirin (1,000 to 1,200 mg per day) or a matched placebo and then followed for an additional 24 weeks. Methods. Hepatitis C virus PNA was detected by reverse-transcription polymerase chain reaction. For determining viral concentration, the commercial bDNA Quantiplex hepatitis C virus-PNA 2.0 assay was used. Genotyping was performed by reverse hybridization assay. Results. At the end of treatment, no detectable hepatitis C virus RNA levels were observed in 92% (24/26) of patients on interferon α2b/ribavirin and 81% (21/26) of patients on interferon α2b/placebo. At the end of the follow-up, a higher sustained virological response rate was seen in patients treated with interferon α2b/ribavirin than those treated with interferon α2b/placebo (69% vs 23%, p<0.001). Patients with either initially high levels of viral concentration or with genotype 1 responded poorly. Patients who received interferon-α2b/ribavirin treatment and in whom no hepatitis C virus PNA was detected at 4th week Conclusions. High-dose interferon-α2b plus ribavirin treatment is highly effective in interferon-relapsed patients.
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