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Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study

Authors Wu X, Zhou J, Xie W, Ding H, Ou X, Chen G, Ma A, Xu X, Ma H, Xu Y, Liu X, Meng T, Wang L, Sun Y, Wang B, Kong Y, Ma H, You H, Jia J

Received 24 August 2018

Accepted for publication 11 February 2019

Published 1 April 2019 Volume 2019:12 Pages 745—757


Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 3

Editor who approved publication: Professor Suresh Antony

Xiaoning Wu,1–3,* Jialing Zhou,1–3,* Wen Xie,4 Huiguo Ding,5 Xiaojuan Ou,1–3 Guofeng Chen,6 Anlin Ma,7 Xiaoyuan Xu,8 Hui Ma,9 Youqing Xu,10 Xiaoqing Liu,11 Tongtong Meng,1–3 Lin Wang,1–3 Yameng Sun,1–3 Bingqiong Wang,1–3 Yuanyuan Kong,1–3 Hong Ma,1–3 Hong You,1–3 Jidong Jia1–3

1Liver Research Centre, Beijing Friendship Hospital, Capital Medical University, Beijing, China; 2Beijing Key Laboratory of Translational Medicine in Liver Cirrhosis, Beijing, China; 3National Clinical Research Center of Digestive Diseases, Beijing, China; 4Liver Fibrosis Centre, Beijing Ditan Hospital, Capital Medical University, Beijing, China; 5Department of Digestive Diseases, Beijing Youan Hospital, Capital Medical University, Beijing, China; 6Liver Fibrosis Centre, Beijing 302 Hospital, Beijing, China; 7Department of Infectious Diseases, China-Japan Friendship Hospital, Beijing, China; 8Department of Infectious Diseases, Peking University First Hospital, Beijing, China; 9Liver Research Centre, Peking University People’s Hospital, Beijing, China; 10Department of Digestive Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China; 11Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing, China

*These authors contributed equally to this work

Background: De novo combination of lamivudine (Lam) and adefovir (Adv) was not rarely used in clinical practice. However, head-to-head comparisons of entecavir (Etv) monotherapy with this combination in hepatitis B virus (HBV)-related compensated cirrhosis patients are unavailable. This study aimed to compare the efficacy and safety of Etv monotherapy with combination therapy in patients with HBV-related compensated liver cirrhosis.
Methods: Treatment-naïve patients with HBV-related compensated liver cirrhosis were recruited to receive either Etv monotherapy or a de novo combination of Lam and Adv. Data were collected at baseline and every 6 months thereafter.
Results: A total of 578 patients (485 in Etv group, 93 in combination group) were included. Baseline characteristics were comparable between the two groups. At the end of 1, 2, and 3 years, HBV DNA was undetectable in 82.7%, 96.2%, and 94.3% of patients in the Etv group and 88.9%, 81.7%, and 84.6% in the combination group, respectively (all P>0.05). The cumulative virological breakthrough rate at 1, 2, and 3 years was 2.7%, 6.7%, and 9.8% in the Etv group and 2.9%, 13.3%, and 32.2% in the combination group, respectively (P=0.003). After propensity-score adjustment for age, sex, and baseline HBeAg, ALT, and total bilirubin, virological breakthrough was higher in the de novo combination of Lam and Adv (HR 2.83, 95% CI 1.37–5.86; P<0.01). The cumulative rate of liver-related events, including decompensation and hepatocellular carcinoma, at 1, 2, and 3 years was 2.9%, 4.2%, and 6.1% in the Etv group and 2.2%, 2.2%, and 6.7% in combination group, respectively (P=0.83). Biochemical response and serological response were similar between the groups.
Conclusion: Etv treatment had less virological breakthrough and potentially higher HBV-DNA suppression than de novo combination of Lam and Adv during 3 years in treatment-naïve HBV-related compensated liver cirrhosis.

Keywords: entecavir, de novo combination, lamivudine, adefovir, compensated HBV-related cirrhosis, real-world, virological breakthrough

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