A pilot study of recombinant interferon beta-1a for the treatment of chronic hepatitis C.
OBJECTIVE
Interferon alpha monotherapy induces a sustained response in less than 20% of patients treated for chronic hepatitis C. Interferon beta represents a potential therapeutic alternative for the treatment of chronic hepatitis C. The aim of this pilot study was to evaluate the efficacy and tolerance of recombinant interferon beta-la administered subcutaneously.


METHODS
Twenty-one drug-naive patients with chronic hepatitis C were treated with recombinant interferon beta-la administered, subcutaneously, for 24 weeks using two different regimens: 9 MU, three times per week (n=11) and 12 MU, three times per week (n=10).


RESULTS
At the end of the treatment period, nine (43%) patients had a biochemical and virological response (i.e. normal ALT and absence of hepatitis C virus RNA by PCR). Four of these patients were in the 9 MU group and five in the 12 MU group. A biochemical and virological sustained response occurred in four (19%) patients, all in the 9 MU dose group. The 4 patients with a sustained response maintained their response during a follow-up period of 33 to 58 months. Side effects were mild and 19 (90%) patients completed the treatment period.


CONCLUSIONS
The results of this pilot study indicate that interferon beta-la administered subcutaneously is an effective therapy for some patients with chronic hepatitis C, and suggest that interferon beta-1a deserves further evaluations in larger trials especially in combination with ribavirin.
Habersetzer
F
F
INSERM U 271, Lyon, France.
Boyer
N
N
Marcellin
P
P
Bailly
F
F
Ahmed
S N
SN
Alam
J
J
Benhamou
J P
JP
Trépo
C
C
D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage / Q000627:therapeutic use*; D008099:Liver / Q000473:pathology; D008103:Liver Cirrhosis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D016133:Polymerase Chain Reaction; D012367:RNA, Viral / Q000032:analysis; D011994:Recombinant Proteins; D016896:Treatment Outcome; D014766:Viremia / Q000188:drug therapy
D007370:Interferon Type I; D012367:RNA, Viral; D011994:Recombinant Proteins