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Abstract Details
Impact of alpha-fetoprotein on hepatocellular carcinoma development during entecavir treatment of chronic hepatitis B virus infection
Yamada R1, Hiramatsu N, Oze T, Morishita N, Harada N, Yakushijin T, Iio S, Doi Y, Yamada A, Kaneko A, Hagiwara H, Mita E, Oshita M, Itoh T, Fukui H, Hijioka T, Katayama K, Tamura S, Yoshihara H, Imai Y, Kato M, Miyagi T, Yoshida Y, Tatsumi T, Kasahara A, Hamasaki T, Hayashi N, Takehara T; the Osaka Liver Forum. J Gastroenterol. 2014 Nov 11. [Epub ahead of print]
Author information
1Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan.
Abstract
BACKGROUND:
Entecavir (ETV) is one of the first-line nucleoside analogs for treating patients with chronic hepatitis B virus (HBV) infection. However, the hepatocellular carcinoma (HCC) risk for ETV-treated patients remains unclear.
METHODS:
A total of 496 Japanese patients with chronic HBV infection undergoing ETV treatment were enrolled in this study. The baseline characteristics were as follows: age 52.6 ± 12.0 years, males 58 %, positive for hepatitis B e antigen 45 %, cirrhosis 19 %, and median HBV DNA level 6.9 log copies (LC) per milliliter. The mean treatment duration was 49.9 ± 17.5 months.
RESULTS:
The proportions of HBV DNA negativity (below 2.6 LC/mL) were 68 % at 24 weeks and 86 % at 1 year, and the rates of alanine aminotransferase (ALT) level normalization were 62 and 72 %, respectively. The mean serum alpha-fetoprotein (AFP) levels decreased significantly at 24 weeks after ETV treatment initiation (from 29.0 ± 137.1 to 5.7 ± 27.9 ng/mL, p < 0.001). The cumulative incidence of HCC at 3, 5, and 7 years was 6.0, 9.6, and 17.2 %, respectively, among all enrolled patients. In a multivariate analysis, advanced age [55 years or older, hazard ratio (HR) 2.84; p = 0.018], cirrhosis (HR 5.59, p < 0.001), and a higher AFP level (10 ng/mL or greater) at 24 weeks (HR 2.38, p = 0.034) were independent risk factors for HCC incidence. HCC incidence was not affected by HBV DNA negativity or by ALT level normalization at 24 weeks.
CONCLUSIONS:
The AFP level at 24 weeks after ETV treatment initiation can be the on-treatment predictive factor for HCC incidence among patients with chronic HBV infection.