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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

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...

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Autores principales: Wu, Xiaoning, Zhou, Jialing, Xie, Wen, Ding, Huiguo, Ou, Xiaojuan, Chen, Guofeng, Ma, Anlin, Xu, Xiaoyuan, Ma, Hui, Xu, Youqing, Liu, Xiaoqing, Meng, Tongtong, Wang, Lin, Sun, Yameng, Wang, Bingqiong, Kong, Yuanyuan, Ma, Hong, You, Hong, Jia, Jidong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6448536/
https://www.ncbi.nlm.nih.gov/pubmed/31015765
http://dx.doi.org/10.2147/IDR.S185120
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author Wu, Xiaoning
Zhou, Jialing
Xie, Wen
Ding, Huiguo
Ou, Xiaojuan
Chen, Guofeng
Ma, Anlin
Xu, Xiaoyuan
Ma, Hui
Xu, Youqing
Liu, Xiaoqing
Meng, Tongtong
Wang, Lin
Sun, Yameng
Wang, Bingqiong
Kong, Yuanyuan
Ma, Hong
You, Hong
Jia, Jidong
author_facet Wu, Xiaoning
Zhou, Jialing
Xie, Wen
Ding, Huiguo
Ou, Xiaojuan
Chen, Guofeng
Ma, Anlin
Xu, Xiaoyuan
Ma, Hui
Xu, Youqing
Liu, Xiaoqing
Meng, Tongtong
Wang, Lin
Sun, Yameng
Wang, Bingqiong
Kong, Yuanyuan
Ma, Hong
You, Hong
Jia, Jidong
author_sort Wu, Xiaoning
collection PubMed
description 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.
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spelling pubmed-64485362019-04-23 Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study Wu, Xiaoning Zhou, Jialing Xie, Wen Ding, Huiguo Ou, Xiaojuan Chen, Guofeng Ma, Anlin Xu, Xiaoyuan Ma, Hui Xu, Youqing Liu, Xiaoqing Meng, Tongtong Wang, Lin Sun, Yameng Wang, Bingqiong Kong, Yuanyuan Ma, Hong You, Hong Jia, Jidong Infect Drug Resist Original Research 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. Dove Medical Press 2019-04-01 /pmc/articles/PMC6448536/ /pubmed/31015765 http://dx.doi.org/10.2147/IDR.S185120 Text en © 2019 Wu et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Wu, Xiaoning
Zhou, Jialing
Xie, Wen
Ding, Huiguo
Ou, Xiaojuan
Chen, Guofeng
Ma, Anlin
Xu, Xiaoyuan
Ma, Hui
Xu, Youqing
Liu, Xiaoqing
Meng, Tongtong
Wang, Lin
Sun, Yameng
Wang, Bingqiong
Kong, Yuanyuan
Ma, Hong
You, Hong
Jia, Jidong
Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study
title Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study
title_full Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study
title_fullStr Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study
title_full_unstemmed Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study
title_short Entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis B virus-related cirrhosis: a real-world prospective multicenter cohort study
title_sort entecavir monotherapy versus de novo combination of lamivudine and adefovir for compensated hepatitis b virus-related cirrhosis: a real-world prospective multicenter cohort study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6448536/
https://www.ncbi.nlm.nih.gov/pubmed/31015765
http://dx.doi.org/10.2147/IDR.S185120
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