Characterization of elevated alanine aminotransferase levels during pegylated-interferon α-2b plus ribavirin treatment for chronic hepatitis C.
OBJECTIVE
Elevation of alanine aminotransferase (ALT) levels during pegylated-interferon (peg-IFN) plus ribavirin therapy in patients with chronic hepatitis C [CHC] is a problem that cannot be disregarded. The aim of this study is to assess the frequency and to characterize clinical parameters of this phenomenon.


METHODS
Two hundred and thirty-five (235) CHC patients with genotype 1b receiving peg-IFN α-2b plus ribavirin therapy were analyzed. Clinical parameters that may be associated with abnormal ALT values during treatment and therapy outcomes were evaluated statistically. One hundred and sixteen (116) patients treated with peg-IFN α-2a plus ribavirin were also included for partial analysis.


RESULTS
Abnormal ALT values during treatment were observed in 23.0% of patients. It was observed in 14.5% of those with sustained virological response (SVR) and 17.8% of those with relapse, in whom viral clearance was observed during therapy. Multivariate logistic regression analysis revealed that pretreatment ALT values, therapy outcome, and body mass index (BMI) were significant factors related to abnormal ALT values during treatment. Abnormal ALT values during treatment became normal in SVR patients at 6 months after the completion of treatment, but not in NR (non-response) patients. Mean ALT values were significantly higher at some time points during treatment in patients treated with α-2a when compared to those treated with α-2b.


CONCLUSIONS
Abnormal ALT values during peg-IFN plus ribavirin treatment are observed relatively frequently, even in patients without detectable HCV RNA. Direct or indirect involvement of drugs is considered as one possible cause.
Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences Niigata University Niigata Municipal Hospital Tachikawa General Hospital Nagaoka Red Cross Hospital Sai-sei-kai Second Hospital Takeda General Hospital Watanabe Clinic, Niigata, Japan.
Yo-Hei
YH
Aoki
Shogo
S
Ohkoshi
Satoshi
S
Yamagiwa
Masahiko
M
Yano
Hiromichi
H
Takahashi
Nobuo
N
Waguri
Kentaro
K
Igarashi
Soh-Ichi
S
Sugitani
Toru
T
Takahashi
Toru
T
Ishikawa
Tomoteru
T
Kamimura
Hiroto
H
Wakabayashi
Toshiaki
T
Watanabe
Yasunobu
Y
Matsuda
Minoru
M
Nomoto
Yutaka
Y
Aoyagi