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

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

Risultato della ricerca: Article

91 Citazioni (Scopus)

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

All Science Journal Classification (ASJC) codes

  • Hepatology

Cita questo

Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C: a randomized controlled trial. / Craxi, Antonio; Di Marco, Vito; Camma', Calogero; Rebucci, Chiara; Pinzello, Giovanbattista; Cammà, Calogero; Rumi, Mariagrazia; Mondelli, Mario U.; Bruno, Savino; Camozzi, Mario; Colombo, Massimo; Vinci, Maria.

In: Journal of Hepatology, Vol. 41, 2004, pag. 474-481.

Risultato della ricerca: Article

Craxi, A, Di Marco, V, Camma', C, Rebucci, C, Pinzello, G, Cammà, C, Rumi, M, Mondelli, MU, Bruno, S, Camozzi, M, Colombo, M & Vinci, M 2004, 'Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C: a randomized controlled trial', Journal of Hepatology, vol. 41, pagg. 474-481.
Craxi, Antonio ; Di Marco, Vito ; Camma', Calogero ; Rebucci, Chiara ; Pinzello, Giovanbattista ; Cammà, Calogero ; Rumi, Mariagrazia ; Mondelli, Mario U. ; Bruno, Savino ; Camozzi, Mario ; Colombo, Massimo ; Vinci, Maria. / Peginterferon alfa-2b plus ribavirin for naive patients with genotype 1 chronic hepatitis C: a randomized controlled trial. In: Journal of Hepatology. 2004 ; Vol. 41. pagg. 474-481.
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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 na{\"i}ve 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 na{\"i}ve 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.",
author = "Antonio Craxi and {Di Marco}, Vito and Calogero Camma' and Chiara Rebucci and Giovanbattista Pinzello and Calogero Camm{\`a} and Mariagrazia Rumi and Mondelli, {Mario U.} and Savino Bruno and Mario Camozzi and Massimo Colombo and Maria Vinci",
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AU - Craxi, Antonio

AU - Di Marco, Vito

AU - Camma', Calogero

AU - Rebucci, Chiara

AU - Pinzello, Giovanbattista

AU - Cammà, Calogero

AU - Rumi, Mariagrazia

AU - Mondelli, Mario U.

AU - Bruno, Savino

AU - Camozzi, Mario

AU - Colombo, Massimo

AU - Vinci, Maria

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N2 - 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.

AB - 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.

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