Clinical efficacy of entecavir therapy and factors associated with treatment response in naive chronic hepatitis B patients.
10.3350/kjhep.2009.15.4.446
- Author:
Myoung Hee LEE
1
;
Sun Gyo LIM
;
Su Jin JEON
;
Chang Joon KANG
;
Young Ju CHO
;
Soon Sun KIM
;
Dami LEE
;
Jae Youn CHEONG
;
Sung Won CHO
Author Information
1. Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea. sung_woncho@hotmail.com
- Publication Type:Original Article ; English Abstract
- Keywords:
Entecavir;
Hepatitis B;
Treatment response;
Predicting factor
- MeSH:
Adult;
Alanine Transaminase/blood;
Antiviral Agents/*therapeutic use;
Aspartate Aminotransferases/blood;
DNA, Viral/blood;
Female;
Guanine/*analogs & derivatives/therapeutic use;
Hepatitis B e Antigens/analysis;
Hepatitis B, Chronic/*drug therapy;
Humans;
Male;
Middle Aged;
Polymerase Chain Reaction;
Retrospective Studies;
Time Factors
- From:The Korean Journal of Hepatology
2009;15(4):446-453
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUND/AIMS: Entecavir is a potent and selective guanosine analogue that has demonstrated a significant antiviral efficacy against hepatitis B virus (HBV). The aim of this study was to characterize the response to entecavir and to examine the factors affecting that response. METHODS: We administered 0.5 mg of entecavir once daily for more than 12 months to 114 naive chronic hepatitis B (CHB) patients. We measured the levels of liver enzymes, serological markers, and serum HBV DNA at 3-month interval. RESULTS: Normalization of serum alanine aminotransferase levels was observed in 68.5% (76/114), 74.6% (85/114), and 81.6% (62/76) of patients after 6, 12, and 24 months of therapy, respectively. HBV DNA levels of <50 copies/mL (as evaluated by polymerase chain reaction) were observed in 43.9% (50/114), 71.1% (81/114), and 85.5% (65/76) of patients after 6, 12, and 24 months, respectively. Viral breakthrough was not observed. The rates of HBeAg loss and seroconversion were 43.5% (27/62) and 14.5% (9/62), respectively, after 12 months of therapy, and 56.4% (22/39) and 15.4% (6/39) after 24 months. The independent factor associated with PCR negativity was early virologic response (EVR; HBV DNA <2,000 copies/mL after 3 months of therapy, P<0.001). The independent factors predicting HBeAg loss were found to be serum albumin levels (P=0.041) and EVR (P=0.005). CONCLUSIONS: Entecavir induced excellent biochemical and virologic responses in naive CHB patients. EVR was an independent factor for predicting HBV PCR negativity and HBeAg loss.
