Interferon β-1a alone or in combination with ribavirin: A randomized trial to compare efficacy and s

• 作 者: 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 Ca
• 机 构: U.O.A.D.U. Gastro-Hepatology S. Giovanni Battista (Molinette) Hospital Turin Italy,Venezia Depart
• 出 处: World Journal of Gastroenterology
• 发表日期: 2005年29期
• 关键词: ribavirin Interferon alone interferon sustained completed Italian stopping naive

AIM: To compare the efficacy and safety of recombinant human IFN β-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 β-1a subcutaneously daily for 24 wk, alone (Group 1, n = 51) or in combination with ribavirin 1000 to 1200 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 (nonsignificant). 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.

AIM: To compare the efficacy and safety of recombinant human IFN β-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 1000 to 1200 mg / d (Group 2, n = 51) : The end-of-treatment virologic response rate was 29.4% in Group 1 and 41.2% in Group 2 (nonsignificant). Twenty-four weeks after stopping therapy, sustained virologic response rate was 21.6% in Group 1 and 27.4% in Group 2 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 ch ronic hepatitis C patients who are unable to tolerate pegylated α-interferon.