Natural human interferon beta plus ribavirin combination therapy in Japanese patients infected with hepatitis C virus and a high viral load.
OBJECTIVE
The aim of this pilot study was to determine the safety and efficacy of natural human interferon beta (nIFNbeta) plus ribavirin (RBV) in patients with chronic hepatitis C who did not respond to pegylated interferon alpha (PEG-IFN), with special emphasis on the incidence of mental disorders or refusal for fear of adverse effects.


METHODS
We studied 19 patients with HCV genotype 1b, 2a or 2b and a high viral load, including 8 patients with mental disorders. They were treated with nIFNbeta-RBV. Eleven patients with HCV genotype 1b of these patients were treated with nIFNbeta-RBV for 48 weeks (group A), and compared with 22 matched controls treated with PEG-IFN plus RBV for 48 weeks (group B). The other 8 patients with HCV genotype 2 were treated with nIFNbeta-RBV for 24 weeks.


RESULTS
Six of 8 patients with mental disorders and 9 of 11 patients without mental disorders completed nIFNbeta-RBV therapy; 1 patient with mental disorder dropped out due to exacerbation of depression, and 3 patients suspended the therapy due to insufficient response. The sustained virological response (SVR) was 27% (3/11) in group A and 41% (9/22) in group B (p = 0.70). During treatment, platelet count increased in group A but not in group B. SVR was 88% (7/8) in patients of genotype 2 and high viral load treated with nIFNbeta plus RBV.


CONCLUSIONS
nIFNbeta-RBV therapy offers sufficient safety and efficacy for patients with mental disorders, and thus could represent an excellent second-line therapy for subpopulations that are not suitable for PEG-IFN-RBV.
Katamura
Yoshio
Y
Department of Hepatology, Toranomon Hospital, Tokyo.
Suzuki
Fumitaka
F
Akuta
Norio
N
Sezaki
Hitomi
H
Yatsuji
Hiromi
H
Nomura
Norihiro
N
Kawamura
Yusuke
Y
Hosaka
Tetsuya
T
Kobayashi
Masahiro
M
Suzuki
Yoshiyuki
Y
Saito
Satoshi
S
Arase
Yasuji
Y
Ikeda
Kenji
K
Kobayashi
Mariko
M
Kumada
Hiromitsu
H
D000328:Adult; D000368:Aged; D044466:Asian People / Q000235:genetics; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics / Q000821:virology; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage*; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy / Q000235:genetics / Q000821:virology; D008875:Middle Aged; D010865:Pilot Projects; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage*; D019562:Viral Load
D012254:Ribavirin; D016899:Interferon-beta