Prolonged treatment with pegylated interferon alpha 2b plus ribavirin improves sustained virological response in chronic hepatitis C genotype 1 patients with late response in a clinical real-life setting in Japan.
OBJECTIVE
This study was conducted to clarify the factors related to sustained virological response (SVR) to pegylated interferon alpha 2b (PEG-IFN) plus ribavirin (RBV) combination therapy administered for 48 weeks in patients with chronic hepatitis C virus (CHCV) and to evaluate the usefulness of prolonged treatment in patients with late virological response (LVR).


METHODS
Of 2257 patients registered at 68 institutions, those with genotype 1 and high viral load were selected to participate in two studies. Study 1 (standard 48-week group, n = 1480) investigated SVR-determining factors in patients who received the treatment for </=52 weeks, whereas study 2 compared SVR rates between patients with LVR who received treatment for either 36-52 weeks (48-week group, n = 223) or 60-76 weeks (72-week group, n = 73).


RESULTS
In study 1, SVR rate was 44.9%; that in male subjects (50.4%) was significantly (P < 0.0001) higher than in female subjects (36.4%). SVR rate significantly (P < 0.0001) decreased with 10-year age increments in both sexes. Multivariate logistic regression analysis revealed that age, F score, platelet count, and HCV load were SVR-related factors. In study 2, SVR rate in the 72-week group (67.1%) was significantly (P = 0.0020) higher than in the 48-week group (46.2%).


CONCLUSIONS
Patients with CHCV genotype 1 infection should be treated with PEG-IFN plus ribavirin combination therapy as early as possible, and 72 weeks' treatment is recommended in patients with LVR regardless of age.
Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan.
Sumio
S
Watanabe
Nobuyuki
N
Enomoto
Kazuhiko
K
Koike
Namiki
N
Izumi
Hajime
H
Takikawa
Etsuko
E
Hashimoto
Fuminori
F
Moriyasu
Hiromitsu
H
Kumada
Michio
M
Imawari