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Aim To evaluate the effect of a multi-disciplinary standardized management model on the efficacy of pegylated (Peg)-interferon α-2b plus ribavirin treatment of chronic hepatitis C in drug addicts undergoing substitutive or antagonist therapy. Design Observational prospective multi-centre study. Setting Six clinical infectious disease centres in collaboration with 11 drug dependency units (DDU) in five Italian regions. Participants Intravenous drug users affected by chronic hepatitis C engaged in detoxification programmes. Methods Application of a multi-disciplinary standardized management model for HCV treatment involving DDU operators, psychologists or psychiatrists and infectious disease specialists. Measurements Very early, early, end-of-treatment and sustained virological response to Peg-interferon α-2b plus ribavirin. Findings Fifty-three subjects were studied [43.4% with hepatitis C virus (HCV) genotypes 1 or 4]. Intent-to-treat analysis showed an end-of-treatment virological response in 58.5% of patients (39.1% genotypes 1 or 4; 73.4% genotype 3) and a sustained virological response in 54.7% (34.8% genotypes 1 or 4; 70.0% genotype 3). There were 19 (35.8%) dropouts and three (5.7%) non-responders: one genotype 1 and two genotype 4. Two (3.8%) patients relapsed: genotypes 1 and 3. On-treatment analysis showed negative HCV-RNA in 40 (93.1%) of 43 subjects who completed the first 12 treatment weeks and in 35 who completed the first 24 treatment weeks. All subjects with an end-of-treatment response, except one with genotype 3 infection, had a sustained response. Conclusions Our data show that antiviral treatment in the context of a multi-disciplinary standardized management model helps many HCV-positive drug addicts achieve a good virological response. [ABSTRACT FROM AUTHOR]

Compares the safety profile and efficacy of the antiviral agent ribavirin combined with leucocyte interferon (IFN)-alpha or with recombinant IFNalpha-2b in treatment-naive patients with chronic hepatitis C. Lower number of adverse events in patients receiving leucocyte IFNalpha; Effectiveness of both regimens in inducing a sustained response in naive patients.