Pellicano R, Craxì A, Almasio PL, Valenza M, Venezia G, Alberti A, Boccato S, Demelia L, Sorbello O, Picciotto A, Torre F, Ideo G, Cattaneo C, Berrutti M, Rizzetto M. Interferon β-1a alone or in combination with ribavirin: A randomized trial to compare efficacy and safety in chronic hepatitis C. World J Gastroenterol 2005; 11(29): 4484-4489 [PMID: 16052676 DOI: 10.3748/wjg.v11.i29.4484]
Corresponding Author of This Article
Professor Mario Rizzetto, U.O.A.D.U. Gastro-Epatologia, Ospedale S. Giovanni Battista (Molinette), Corso Bramante 88-10126 Torino, Italy. mario.rizzetto@unito.it
Article-Type of This Article
Viral Hepatitis
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World J Gastroenterol. Aug 7, 2005; 11(29): 4484-4489 Published online Aug 7, 2005. doi: 10.3748/wjg.v11.i29.4484
Interferon β-1a alone or in combination with ribavirin: A randomized trial to compare efficacy and safety in chronic hepatitis C
Rinaldo Pellicano, Antonio Craxì, 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
Rinaldo Pellicano, Mara Berrutti, Mario Rizzetto, U.O.A.D.U. Gastro-Hepatology, S. Giovanni Battista (Molinette) Hospital, Turin, Italy
Antonio Craxì, Piero Luigi Almasio, Mario Valenza, Giovanna Venezia, Department of Gastroenterology and Hepatology, University of Palermo, Italy
Alfredo Alberti, Silvia Boccato, Department of Internal Medicine, University of Padua, Italy
Luigi Demelia, Orazio Sorbello, Institute of Clinical Medicine, University of Cagliari, Italy
Antonino Picciotto, Francesco Torre, Department of Internal Medicine, University of Genoa, Italy
Gaetano Ideo, Carlo Cattaneo, Department of Hepatology, San Giuseppe Hospital, Milan, Italy
Author contributions: All authors contributed equally to the work.
Supported by an Unrestricted Grant From Industria Farmaceutica Serono S.p.A. (Rome, Italy). The Antiviral Drugs Employed in this Study were Also Made Available by Serono
Correspondence to: Professor Mario Rizzetto, U.O.A.D.U. Gastro-Epatologia, Ospedale S. Giovanni Battista (Molinette), Corso Bramante 88-10126 Torino, Italy. mario.rizzetto@unito.it
Telephone: +39-11-6336397 Fax: +39-11-6335927
Received: May 12, 2004 Revised: September 15, 2004 Accepted: September 20, 2004 Published online: August 7, 2005
Abstract
AIM: To compare the efficacy and safety of recombinant human IFN β-1a alone or in combination with ribavirin in treatment-naïve 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 β-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 β-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 α-interferon.
