Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C.
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.
Pellicano
Rinaldo
R
U.O.A.D.U. Gastro-Epatologia, Ospedale S. Giovanni Battista (Molinette), Corso Bramante 88-10126 Torino, Italy.
Craxi
Antonio
A
Almasio
Piero-Luigi
PL
Valenza
Mario
M
Venezia
Giovanna
G
Alberti
Alfredo
A
Boccato
Silvia
S
Demelia
Luigi
L
Sorbello
Orazio
O
Picciotto
Antonino
A
Torre
Francesco
F
Ideo
Gaetano
G
Cattaneo
Carlo
C
Berrutti
Mara
M
Rizzetto
Mario
M
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
D000276:Adjuvants, Immunologic; D000998:Antiviral Agents; D012254:Ribavirin; D016899:Interferon-beta; D000068556:Interferon beta-1a