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Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.

Author(s): Pellicano R, Craxi 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

Affiliation(s): U.O.A.D.U. Gastro-Epatologia, Ospedale S. Giovanni Battista (Molinette), Corso Bramante 88-10126 Torino, Italy.

Publication date & source: 2005-08-07, World J Gastroenterol., 11(29):4484-9.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

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.

Page last updated: 2006-01-31

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