Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C: a randomized controlled trial

Vito Di Marco, Calogero Camma', Antonio Craxi, Massimo Colombo, Maria Vinci, Chiara Rebucci, Giovanbattista Pinzello, Calogero Cammà, Mariagrazia Rumi, Mario U. Mondelli, Savino Bruno, Mario Camozzi

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Abstract

We assessed the effectiveness and safety of an induction dose of peginterferon alfa-2b (PEG-IFN) plus ribavirin for initial treatment of patients with genotype 1 chronic HCV infection in a randomized, controlled, multicenter trial.Three hundred and eleven naïve patients infected with genotype 1 and chronic hepatitis were randomly assigned to 48-week treatment with PEG-IFN once weekly (80-100 μg depending on body weight for 8 weeks, followed by 50 μg for the next 40 weeks), or standard interferon alfa-2b (IFN) 6 million units on alternate days, both in combination with ribavirin (1000-1200 mg/day).PEG-IFN plus ribavirin significantly increased sustained virological response (SVR) compared with IFN plus ribavirin (41.1 vs. 29.3% respectively, P=0.030). Less patients discontinued PEG-IFN than IFN (19 vs. 31%, P=0.010). By logistic regression, SVR in the PEG-IFN group was independently associated with age <50 years, and mild fibrosis at liver biopsy.Combination therapy with an induction dose of PEG-IFN was a more effective and better tolerated treatment for naïve patients with genotype 1 than combination therapy with high dose standard IFN. In patients aged less than 50 years with mild fibrosis this schedule achieves a very high rate of SVR.
Lingua originaleEnglish
pagine (da-a)474-481
Numero di pagine8
RivistaJournal of Hepatology
Volume41
Stato di pubblicazionePublished - 2004

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All Science Journal Classification (ASJC) codes

  • Hepatology

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Di Marco, V., Camma', C., Craxi, A., Colombo, M., Vinci, M., Rebucci, C., Pinzello, G., Cammà, C., Rumi, M., Mondelli, M. U., Bruno, S., & Camozzi, M. (2004). Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C: a randomized controlled trial. Journal of Hepatology, 41, 474-481.