Interferon Beta-1a Alone or in Combination with Ribavirin: a Randomized Trial to Compare Efficacy and Safety in Chronic Hepatitis C

Overview

Journal World J Gastroenterol

Publisher Baishideng Publishing Group

Specialty Gastroenterology

Date 2005 Jul 30

PMID 16052676

Citations 6

Authors

Rinaldo Pellicano

Antonio Craxi

Piero-Luigi Almasio

Mario Valenza

Giovanna Venezia

Alfredo Alberti

Silvia Boccato

Luigi Demelia

Orazio Sorbello

Antonino Picciotto

Francesco Torre

Gaetano Ideo

Carlo Cattaneo

Mara Berrutti

Mario Rizzetto

Affiliations

Soon will be listed here.

Abstract

Aim: To compare the efficacy and safety of recombinant human IFN beta-1a alone or in combination with ribavirin in treatment-naive subjects with chronic hepatitis C.

Methods: Open, randomized trial was performed in 6 Italian tertiary centers: 102 of the 108 patients screened were randomized to receive 6 MIU of recombinant human IFN beta-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1,000 to 1,200 mg/d (Group 2, n = 51).

Results: The end-of-treatment virologic response rate was 29.4% in Group 1 and 41.2% in Group 2 (non-significant). Twenty-four weeks after stopping therapy, sustained virologic response rate was 21.6% in Group 1 and 27.4% in Group 2 (non-significant). All subjects in Group 1 completed treatment, while two subjects in Group 2 stopped therapy due to treatment-related adverse events.

Conclusion: Recombinant human IFN beta-1a, alone or in combination with ribavirin, has an excellent safety profile and, may represent an alternative for chronic hepatitis C patients who are unable to tolerate pegylated alpha-interferon.

Citing Articles

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