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Liver International
Four-Year Entecavir Therapy Reduces Hepatocellular Carcinoma, Cirrhotic Events and Mortality in Chronic Hepatitis B Patients
Tung-Hung Su; Tsung-Hui Hu; Chi-Yi Chen; Yi-Hsiang Huang; Wan-Long Chuang; Chun-Che Lin; Chia-Chi Wang; Wei-Wen Su; Ming-Yao Chen; Cheng-Yuan Peng; Rong-Nan Chien; Yi-Wen Huang; Horng-Yuan Wang; Chih-Lin Lin; Sheng-Shun Yang; Tsung-Ming Chen; Lein-Ray Mo; Shih-Jer Hsu; Kuo-Chih Tseng; Tsai-Yuan Hsieh; Fat-Moon Suk; Chi-Tan Hu; Ming-Jong Bair; Cheng-Chao Liang; Yung-Chao Lei; Tai-Chung Tseng; Chi-Ling Chen; Jia-Horng Kao
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Abstract and Introduction
Abstract
Background & Aims: Oral antiviral therapy may reduce the disease progression of chronic hepatitis B (CHB) patients. We aimed to further investigate the efficacy of long-term entecavir therapy in reduction of the risk of hepatocellular carcinoma (HCC), cirrhotic events and mortality in a large group of CHB-related cirrhosis patients.
Methods: The C-TEAM (Cirrhosis-Taiwanese EntecAvir Multicenter) study was a nationwide, multicenter, retrospective–prospective cohort study in Taiwan. We enrolled treatment-naïve patients with CHB-related cirrhosis and baseline HBV-DNA≥2000 IU/mL receiving long-term entecavir therapy and compared the development of HCC, cirrhotic events and mortality with that of a historical untreated cohort.
Results: In total, 1315 entecavir-treated and 503 untreated patients with cirrhosis were enrolled, with median treatment and follow-up durations of 4 and 6 years respectively. Compared with the untreated cohort, entecavir therapy was associated with a 60% HCC risk reduction [hazard ratio (HR): 0.40, 95% confidence interval (CI): 0.28–0.57]. Additionally, an older age, the male gender, HBeAg positivity, alpha-fetoprotein (AFP)≥7 ng/mL before therapy were independent predictors of HCC development. Further analysis showed that entecavir therapy significantly reduced risks of variceal bleeding, spontaneous bacterial peritonitis, and liver-related and all-cause mortality. These findings were confirmed by propensity score-matched cohorts in sensitivity analysis. In patients under entecavir therapy, an older age, the male gender, HBeAg positivity, AFP level ≥7 ng/mL before therapy, and 1-year virological response were predictive of HCC development.
Conclusions: Four-year entecavir therapy significantly reduces the risk of HCC, cirrhotic events and mortality in patients with CHB-related cirrhosis.
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