title: Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: U.O.A.D.U. Gastro-Epatologia, Ospedale S. Giovanni Battista (Molinette), Corso Bramante 88-10126 Torino, Italy.
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Pellicano
authors.forename: Antonio
authors.initials: A
authors.lastname: Craxi
authors.forename: Piero-Luigi
authors.initials: PL
authors.lastname: Almasio
authors.forename: Mario
authors.initials: M
authors.lastname: Valenza
authors.forename: Giovanna
authors.initials: G
authors.lastname: Venezia
authors.forename: Alfredo
authors.initials: A
authors.lastname: Alberti
authors.forename: Silvia
authors.initials: S
authors.lastname: Boccato
authors.forename: Luigi
authors.initials: L
authors.lastname: Demelia
authors.forename: Orazio
authors.initials: O
authors.lastname: Sorbello
authors.forename: Antonino
authors.initials: A
authors.lastname: Picciotto
authors.forename: Francesco
authors.initials: F
authors.lastname: Torre
authors.forename: Gaetano
authors.initials: G
authors.lastname: Ideo
authors.forename: Carlo
authors.initials: C
authors.lastname: Cattaneo
authors.forename: Mara
authors.initials: M
authors.lastname: Berrutti
authors.forename: Mario
authors.initials: M
authors.lastname: Rizzetto
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D000998:Antiviral Agents; D012254:Ribavirin; D016899:Interferon-beta; D000068556:Interferon beta-1a