Efficacy of prolonged 5 million units of interferon in combination with ribavirin for relapser patients with chronic hepatitis C |
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Authors: | Fattovich G Zagni I Fornaciari G Minola E Fabris P Boccia S Giusti M Abbati G Felder M Rovere P Redaelli A Tonon A Montanari R Paternoster C Distasi M Castagnetti E Tositti G Rizzo C Suppressa S Pantalena M Lomonaco L Scattolini C Tagger A |
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Institution: | Servizio Autonomo Clinicizzato di Gastroenterologia, Universitàdi Verona, Verona;;Divisione di Gastroenterologia, Arcispedale S. Maria Nuova, Reggio Emilia;;Divisione di Malattie Infettive, Ospedali Riuniti, Bergamo;;Divisione di Malattie Infettive, Ospedale S. Bortolo, Vicenza;;Divisione di Gastroenterologia, Ospedale S. Anna, Ferrara;;Divisione di Medicina, Azienda USL 3, Pistoia;;Clinica Medica 2a, Universitàdi Modena, Modena;;Divisione di Gastroenterologia, Ospedale Regionale, Bolzano;;Divisione Malattie Infettive, Ospedale Civile, Legnago;;Divisione di Medicina, Ospedale S. Gerardo dei Tintori, Monza;;Divisione di Gastroenterologia, Azienda Ospedaliera, Verona;;Divisione di Gastroenterologia, Ospedale Sacro Cuore, Negrar;;Divisione Malattie Infettive, Presidio Ospedaliero 'Villa Igea', Trento;;Divisione di Gastroenterologia, Polichirurgico, Piacenza;;Dipartimento di Medicina, Ospedale di Arzignano, Arzignano;and;Istituto di Virologia, Universitàdi Milano, Milano, Italy |
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Abstract: | summary. Retreatment of relapser patients with chronic hepatitis C with the standard dose of interferon (IFN) of 3 million units (MU) thrice weekly (tiw) plus ribavirin for 24 weeks achieves a sustained response in 30 and 73% of patients with genotype 1 and 2 or 3, respectively. The aim of this study was to evaluate the efficacy and safety of IFN α -2b induction therapy, followed by prolonged treatment with a high dose of IFN α -2b plus ribavirin in relapser patients. A total of 119 patients were randomized to receive IFN α -2b 5 MU daily (Group A: 59 patients) or IFN α -2b 5 MU tiw (Group B: 60 patients) for 4 weeks followed by IFN (5 MU tiw) and ribavirin (1000–1200 mg/day) for 48 weeks in both groups. The primary end point was hepatitis C virus (HCV)-RNA clearance at week 24 after the end of treatment. A sustained virological response (SVR) was achieved in 68 and 60% of Group A and B patients, respectively ( P = 0.37). Logistic regression analysis identified genotype 2 or 3 as the only independent factor associated with response, whereas induction regimen and baseline viraemia levels did not affect the response. The overall SVR was 53 and 72% in patients with genotype 1 or 4 and 2 or 3, respectively. In conclusion, induction IFN therapy does not enhance the SVR to a 48-week combination therapy. Our study suggests that relapsed patients with genotype 1 or 4 may achieve significant response rates of approximately 50%, if retreated with 5 MU tiw IFN plus ribavirin for 48 weeks. |
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Keywords: | chronic hepatitis C HCV genotype 1 or 4 high dose interferon prolonged therapy ribavirin therapy of relapse |
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