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Korean J Hepatol > Volume 15(4); 2009 > Article
The Korean Journal of Hepatology 2009;15(4): 446-453.
doi: http://dx.doi.org/10.3350/kjhep.2009.15.4.446
Clinical efficacy of entecavir therapy and factors associated with treatment response in naive chronic hepatitis B patients
Myoung Hee Lee , Sun Gyo Lim , Su Jin Jeon , Chang Joon Kang , Young Ju Cho , Soon Sun Kim , Da Mi Lee , Jae Youn Cheong , Sung Won Cho
Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea
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. (Korean J Hepatol 2009;15:446-453)
KeyWords: Entecavir; Hepatitis B; Treatment response; Predicting factor
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