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KMID : 0338420170320040636
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The Korean Journal of Internal Medicine
2017 Volume.32 No. 4 p.636 ~ p.646
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Long-term real-world entecavir therapy in treatment-naive hepatitis B patients: base-line hepatitis B virus DNA and hepatitis B surface antigen levels predict virologic response
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Cho Ju-Yeon
Sohn Won
Sinn Dong-Hyun
Gwak Geum-Youn
Paik Yong-Han
Choi Moon-Seok
Koh Kwang-Cheol
Paik Seung-Woon
Yoo Byung-Chul
Lee Joon-Hyeok
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Abstract
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Background/Aims: Entecavir is a potent nucleoside analogue with high efficacy and barrier for resistance. We aimed to investigate the long-term efficacy and viral resistance rate of entecavir and explore the factors associated with virologic response, including quantitative hepatitis B surface antigen (qHBsAg) levels.
Methods: One thousand and nine treatment-naive chronic hepatitis B (CHB) patients were evaluated for cumulative rates of virologic response, biochemical response, and entecavir mutations. The role of baseline qHBsAg for virologic response was assessed in 271 patients with qHBsAg prior to entecavir treatment.
Results: The median duration of entecavir treatment was 26.5 months. The cumulative rate of virologic response at years 1, 3, and 5 were 79.0%, 95.6%, and 99.4%, respectively. The cumulative rate of entecavir resistance was 1.0% and 2.1% in years 3 and 5. Multivariate analysis identified baseline hepatitis B e antigen (HBeAg) negative status (p < 0.001) and lower hepatitis B virus (HBV) DNA (p < 0.001) as predictors of virologic response. Lower qHBsAg was an independent predictor of virologic response in patients with baseline qHBsAg. There were no serious adverse events during treatment.
Conclusions: Long-term entecavir treatment of nucleos(t)ide-naive CHB patients was associated with an excellent virologic response and a low rate of entecavir-resistant mutations at 5 years. Baseline HBV DNA load, qHBsAg levels, and HBeAg status were predictors of virologic response during entecavir treatment.
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KEYWORD
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Hepatitis B virus, Entecavir, Quantitative hepatitis B surface antigens, Virologic response
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