Efficacy and safety of combination therapy of natural human interferon beta and ribavirin in chronic hepatitis C patients with genotype 1b and high virus load.
OBJECTIVE
The aim of this study was to evaluate the efficacy of combination therapy of natural human interferon-beta and ribavirin in patients infected with hepatitis C virus (HCV) genotype 1b.


METHODS
Inclusion criteria were HCV-genotype 1b, serum HCV RNA level of >or=100 KIU/ml before the initiation of treatment. A total of 40 patients were enrolled in this retrospective cohort study. The treatment period of combination therapy was 48 weeks. Nonparametric procedures were employed for the analysis of background features of the patients with SVR and without SVR. A p value of <0.05 was considered to indicate a significant difference.


RESULTS
Of the 40 study patients, ten had mental disorders before the initiation of combination therapy. One of the patients stopped the treatment due to exacerbation of depression and another patient stopped due to a skin rash. Three patients suspended the therapy due to an insufficient response of positive serum HCV RNA at 24 weeks after the initiation of treatment. Thus, 34 patients completed combination therapy. Fifteen had sustained virological response (SVR). The SVR rate in patients who showed negative HCV RNA 8 weeks after the initiation of combination therapy was 86.7% (13/15). On the other hand, the SVR rate in patients who showed positive HCV RNA at 8 weeks was 8% (2/25) (p<.001). Continuous period of negative serum HCV RNA was 33.1 weeks in SVR groups, and 12.5 weeks in non-SVR groups (p<.001).


CONCLUSIONS
The combination therapy of IFN-beta and ribavirin is a possible therapy selection for patients with type C hepatitis of genotype 1b and high virus load.
Department of Hepatology and Okinaka Memorial Institute for Medical Research, Toranomon Hospital, Tokyo, Japan. es9y-ars@asahi-net.or.jp
Yasuji
Y
Arase
Fumitaka
F
Suzuki
Norio
N
Akuta
Hitomi
H
Sezaki
Yoshiyuki
Y
Suzuki
Yusuke
Y
Kawamura
Masahiro
M
Kobayashi
Tetsuya
T
Hosaka
Hiromi
H
Yatsuji
Miharu
M
Hirakawa
Satoshi
S
Saito
Kenji
K
Ikeda
Mariko
M
Kobayashi
Hiromitsu
H
Kumada
D000328:Adult; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000235:genetics*; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D019562:Viral Load / Q000235:genetics*
D011994:Recombinant Proteins; D012254:Ribavirin; D016899:Interferon-beta