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Kim, Mun, Koo, Kang, Bak, Cheong, and Cho: Entecavir Therapy for Patients with Hepatitis B Virus-related Decompensated Cirrhosis
Original Article
Liver
The Korean Journal of Gastroenterology

The Korean Journal of Gastroenterology 2012; 59(3): 224-231.

Published online: 21 March 2012

DOI: https://doi.org/10.4166/kjg.2012.59.3.224

Entecavir Therapy for Patients with Hepatitis B Virus-related Decompensated Cirrhosis

In Sung Kim, Jun Il Mun, Jee Hoon Koo, Chang Jun Kang, Jean Kyung Bak1, Jae Yoeun Cheong, Sung Won Cho

Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.

1Department of Biostatistics, Yonsei University School of Medicine, Seoul, Korea.

Correspondence to: Sung Won Cho, Department of Gastroenterology, Ajou University School of Medicine, San 5, Woncheon-dong, Yontong-gu, Suwon 442-421, Korea. Tel: +82-31-219-5149, Fax: +82-31-219-5999, sung_woncho@hotmail.com

Received 1 August 2011       Revised 21 September 2011       Accepted 27 September 2011

Copyright © 2012 The Korean Society of Gastroenterology

(open-access):

This is an open access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background/Aims

Entecavie (ETV) has a potent antiviral effect and low rates of resistance in hepatitis B virus (HBV) and is the first-line monotherapy in patients with HBV-related decompensated cirrhosis. We evaluated the efficacy of 12 months treatment with ETV and tried to determine predictive factors of response.

Methods

Forty-five consecutive decompensated cirrhotic patients who received ETV (0.5 mg/day) for more than six months were included. All patients were positive for HBV DNA, and the Child-Turcotte-Pugh (CTP) scores were over 8 point. Seventeen patients were HBeAg-positive. CTP score, model for end-stage liver disease (MELD) score, serum markers of liver function and HBV DNA were assessed every 3 months.

Results

ETV treatment for 12 months resulted in improvement of CTP and MELD scores. Pre-treatment mean CTP and MELD score were decreased from 10.1 (±2.0) and 13.48 (±4.05) to 7.24 (±2.0) and 9.68 (±4.85) at 12 months, respectively. The 1-year cumulative rates of HBV DNA negativity and HBeAg loss were 88.9% and 52.9%, respectively, by intention-to-treat analysis. Thirty-two (71.1%) showed improvement in CTP score. Eleven patients did not show change, and 2 patients got worse. The AST/ALT, albumin, bilrubin, prothrombin time were significantly normalized within six months. The good responder group had high level of prothrombin time than the poor responder group (p=0.004).

Conclusions

Our result shows that entecavir can improve liver function in about 70% of patients with HBV related decompensated liver cirrhosis. INR may be a predictive factor of good response with entecavir in these patients.

Keywords: Entecavir, Liver cirrhosis, Hepatitis B virus

Figures and Tables

Fig. 1
Changes of ALT, albumin, bilirubin, and prothrombin time during entecavir treatment.
kjg-59-224-g001
Fig. 2
Changes of Child-Turcotte-Pugh (CTP) score and model for end stage liver disease (MELD) score during entecavir therapy.
kjg-59-224-g002
Fig. 3
Clinical outcome of 45 patients treated with entecavir therapy.
kjg-59-224-g003
Table 1
Baseline Characteristics
kjg-59-224-i001

Values are presented as mean±SD, mean (range), or n (%).

CTP, Child-Turcotte-Pugh; MELD, model for end stage liver disease; HEP, hepatic encephalopathy.

Table 2
Virologic, Serologic, and Biochemical Response to Entecavir
kjg-59-224-i002

Values are presented as mean±SD or n (%).

CTP, Child-Turcotte-Pugh; MELD, model for end stage liver disease.

Early dead patients were excluded in results.

aEarly dead patients were included. Total number of patients were 48.

Table 3
Comparison of Virologic and Biochemical Response to Entecavir between the Responder and Non-Responder Groups
kjg-59-224-i003

Values are presented as mean±SD. The results were used by an item deletion method about missing values in each follow-up data of every interest factors.

R, responder group, defined as a decrease in CTP score of ≥2; NR, non-responder group, defined as a decrease in CTP score of ≤1 or an increase; CTP, Child-Turcotte-Pugh; MELD, model for end stage liver disease.

Table 4
Univatiate Analysis for Factors Associated with Therapeutic Effectiveness in Decompensated Cirrhosis
kjg-59-224-i004

MELD, model for end stage liver disease; HEP, hepaticencephalopathy.

Table 5
Factors Associated with Therapeutic Effectiveness in Decompensated Cirrhosis
kjg-59-224-i005

This results were analyzed using the variables that are derived from best subset selection.

Notes

Financial support: This work was supported by a grant from Ministry of Health and Welfare, Republic of Korea (A102065).

Conflict of interest: None.

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