Brief Article
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World J Gastroenterol. Oct 7, 2013; 19(37): 6278-6283
Published online Oct 7, 2013. doi: 10.3748/wjg.v19.i37.6278
De novo combined lamivudine and adefovir dipivoxil therapy vs entecavir monotherapy for hepatitis B virus-related decompensated cirrhosis
Jiang-Shan Lian, Lin-Yan Zeng, Jian-Yang Chen, Hong-Yu Jia, Yi-Min Zhang, Dai-Rong Xiang, Liang Yu, Jian-Hua Hu, Ying-Feng Lu, Ling Zheng, Lan-Juan Li, Yi-Da Yang
Jiang-Shan Lian, Lin-Yan Zeng, Jian-Yang Chen, Hong-Yu Jia, Yi-Min Zhang, Dai-Rong Xiang, Liang Yu, Jian-Hua Hu, Ying-Feng Lu, Ling Zheng, Lan-Juan Li, Yi-Da Yang, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, Zhejiang Province, China
Author contributions: Lian JS and Zeng LY contributed equally to this work; Lian JS, Zeng LY and Chen JY performed the majority of experiments; Jia HY, Zhang YM, Xiang DR, Yu L, Hu JH, Lu YF provided analytical tools and revised the manuscript; Zheng L, Li LJ and Yang YD designed the study; Lian JS and Yang YD wrote the manuscript.
Supported by the National Key Program for Infectious Diseases of China to Yang YD, 2013ZX10002001; and 12th Five-Year Significant New Drugs Creation Plan of the Ministry of Science and Technology of China to Yang YD, 2011ZX09302-003-03
Correspondence to: Dr. Yi-Da Yang, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, the First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Road, Hangzhou 310003, Zhejiang Province, China. yangyida65@163.com
Telephone: +86-571-87236731 Fax: +86-571-87236755
Received: June 12, 2013
Revised: July 29, 2013
Accepted: August 20, 2013
Published online: October 7, 2013
Processing time: 128 Days and 0.2 Hours
Abstract

AIM: To compare efficacy of combined lamivudine (LAM) and adefovir dipivoxil (ADV) therapy with that of entecavir (ETV) monotherapy for hepatitis B virus (HBV)-related decompensated liver cirrhosis.

METHODS: A total of 120 naïve patients with HBV-related decompensated cirrhosis participated in this study. Sixty patients were treated with combined LAM and ADV therapy (LAM + ADV group), while the other 60 were treated with ETV monotherapy (ETV group) for two years. Tests for liver and kidney function, alpha-fetoprotein, HBV serum markers, HBV DNA load, prothrombin time (PT), and ultrasonography or computed tomography scan of the liver were performed every 1 to 3 mo. Repeated measure ANOVA and the χ2 test were performed to compare the efficacy, side effects, and the cumulative survival rates at 48 and 96 wk.

RESULTS: Forty-five patients in each group were observed for 96 wk. No significant differences in HBV DNA negative rates and alanine aminotransferase (ALT) normalization rates at weeks 48 (χ2 = 2.12 and 2.88) and 96 (χ2 = 3.21 and 3.24) between the two groups were observed. Hepatitis B e antigen seroconversion rate in the LAM + ADV group at week 96 was significantly higher in the ETV group (43.5% vs 36.4%, χ2 = 4.09, P < 0.05). Viral breakthrough occurred in 2 cases (4.4%) by week 48 and in 3 cases (6.7%) by week 96 in the LAM + ADV group, and no viral mutation was detected. In the ETV group, viral breakthrough occurred in 1 case (2.2%) at the end of week 96. An increase in albumin (F = 18.9 and 17.3), decrease in total bilirubin and in ALT (F = 16.5, 17.1 and 23.7, 24.8), reduced PT (F = 22.7 and 24.5), and improved Child-Turcotte-Pugh and the model for end-stage liver disease scores (F = 18.5, 17.8, and 24.2, 23.8) were observed in both groups. The cumulative rates of mortality and liver transplantation were 16.7% (10/60) and 18.3% (11/60) in the LAM + ADV and ETV groups, respectively.

CONCLUSION: Both LAM + ADV combination therapy and ETV monotherapy can effectively inhibit HBV replication, improve liver function, and decrease mortality.

Keywords: Chronic hepatitis B; Decompensated liver cirrhosis; Lamivudine; Adefovir dipivoxil; Combination therapy; Entecavir

Core tip: This study compared the de novo efficacy of combined lamivudine (LAM) and adefovir dipivoxil (ADV) therapy with that of entecavir (ETV) monotherapy for patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis. Both LAM + ADV combination therapy and ETV monotherapy can effectively inhibit HBV replication, improve liver function, and decrease mortality. The data obtained in this study demonstrate the efficacy and the safety of these treatment regimens for 96 wk in patients with HBV-related decompensated liver cirrhosis.