Prospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jul 7, 2015; 21(25): 7869-7876
Published online Jul 7, 2015. doi: 10.3748/wjg.v21.i25.7869
Long-term antiviral efficacy of entecavir and liver histology improvement in Chinese patients with hepatitis B virus-related cirrhosis
Yan Xu, Yong-Gui Zhang, Xu Wang, Wen-Qian Qi, Shao-You Qin, Zhen-Hua Liu, Jian Jiao, Jiang-Bin Wang
Yan Xu, Yong-Gui Zhang, Xu Wang, Wen-Qian Qi, Shao-You Qin, Zhen-Hua Liu, Jian Jiao, Jiang-Bin Wang, Department of Gastroenterology, China-Japan Union Hospital, Jilin University, Changchun 130033, Jilin Province, China
Author contributions: Xu Y, Zhang YG and Wang JB designed the research; Wang X and Liu ZH performed the research; Zhang YG, Qi WQ and Jiao J contributed new reagents or analytic tools; Xu Y and Qin SY analyzed the data; Xu Y and Zhang YG wrote the paper.
Supported by Grant from the Youth scientific research fund, No. 2013207059.
Conflict-of-interest statement: We declare that we have no financial or personal relationships with other people or organizations that could inappropriately influence our work; there is no professional or other personal interest of any nature in any product, service and/or company that could be construed as influencing the position presented herein.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Jiang-Bin Wang, Professor, Department of Gastroenterology, China-Japan Union Hospital, Jilin University, No. 126 Xiantai Dajie, Changchun 130033, Jilin Province, China. yongguizhangcn@126.com
Telephone: +86-431-84995303 Fax: +86-431-84641026
Received: August 20, 2014
Peer-review started: August 21, 2014
First decision: November 14, 2014
Revised: March 4, 2015
Accepted: May 11, 2015
Article in press: May 11, 2015
Published online: July 7, 2015
Processing time: 321 Days and 14.2 Hours
Abstract

AIM: To evaluate the clinical outcomes of 240-wk treatment with entecavir (0.5 mg) in Chinese nucleoside-naive patients with cirrhosis.

METHODS: A total of 204 nucleoside-naive patients with compensated (n = 96) or decompensated (n = 108) hepatitis B virus (HBV)-induced cirrhosis at the Department of Gastroenterology of the China-Japan Union Hospital (Jilin University, Changchun, China) who were treated with entecavir (0.5 mg) for 240 wk were enrolled in this study. Liver biopsy samples obtained from 38 patients prior to treatment (baseline) and at week 240 were evaluated by different independent histopathologists. Efficacy assessments included the proportions of patients who achieved an HBV DNA level < 500 copies/mL, the association of interleukin-28B genetic variation with antivirus therapy, clinical outcomes, and histologic improvement. Changes in liver disease severity were analyzed, and liver histologic evaluation was performed in 38 patients with paired biopsies. Student t tests were used to compare the means of continuous variables between the groups, and the proportions of patients who achieved the endpoints were compared using the χ2 test.

RESULTS: At week 240, 87.5% of the patients with compensated cirrhosis and 92.6% of the patients with decompensated cirrhosis achieved a HBV DNA level < 500 copies/mL. Three patients had genotypic entecavir resistance within the 240-wk period. No significant association was observed between virologic response and interleukin-28 genotype (CT, 88.2% vs CC, 90.6%). The proportion of patients with Child-Pugh class A disease was significantly increased at week 240 (68%) from the baseline (47%; P < 0.01). The proportion of patients with Child-Pugh class B disease was significantly decreased at week 240 (25%) from the baseline (39%; P = 0.02). In the patients with paired liver biopsies, the mean reduction in the Knodell necroinflammatory score from the baseline was 3.58 ± 1.03 points (7.11 ± 1.80 vs 3.53 ± 1.35, P < 0.01). The mean reduction in Ishak fibrosis score from the baseline was 1.26 ± 0.64 points (5.58 ± 0.50 vs 4.32 ± 0.81, P < 0.01).

CONCLUSION: Entecavir is an effective treatment option for patients with HBV-related compensated or decompensated cirrhosis that can result in sustained virologic suppression and histologic improvement.

Keywords: Decompensated cirrhosis; Hepatic function; Histologic improvement; Knodell histologic activity index score; Nucleoside analog

Core tip: Entecavir is a potent antiviral agent that is effective and safe for the treatment of chronic hepatitis B. However, data on its clinical benefits in patients with cirrhosis, especially in long-term treatment, are limited. The aims of this prospective study were to evaluate the antiviral efficacy and clinical outcomes of entecavir treatment for 240 wk in nucleoside-naive Chinese patients with chronic hepatitis B, and compensated or decompensated cirrhosis.