Bingliang Lin1, Calvin Q Pan2, Dongying Xie1, Junqiang Xie1, Shibin Xie1, Xiaohong Zhang1, Biao Wu3, Chaoshuang Lin1, Zhiliang Gao4. 1. Department of Infectious Diseases, Third Affiliated Hospital of Sun Yet-Sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510060, People's Republic of China. 2. Division of Liver Diseases, Department of Medicine, Mount Sinai Medical Center, Mount Sinai School of Medicine, New York, NY, USA. 3. Department of Infectious Diseases, Hainan Provincial People's Hospital, Haikou, People's Republic of China. 4. Department of Infectious Diseases, Third Affiliated Hospital of Sun Yet-Sen University, 600 Tianhe Road, Tianhe Area, Guangzhou, 510060, People's Republic of China. zlgao99@hotmail.com.
Abstract
BACKGROUND: The mortality of acute-on-chronic hepatitis B liver failure (ACHBLF) from acute exacerbation of chronic hepatitis B is 30-70 % without liver transplant. METHODS: We conducted an open-label, prospective, 48-week study to evaluate the efficacy of entecavir (ETV) in ACHBLF with 110 patients who received either ETV or no treatment. Primary measurements were survival and improvement in disease severity scores. RESULTS: Of the 110 patients enrolled, 2 withdrew consent, 108 were treated with 53 ETV, and 55 were untreated. When compared to the patients in the untreated group at week 48, a lower cumulative mortality rate in ETV-treated patients was observed [54.7 % (29/53) vs. 78.2 % (43/55), p < 0.01). ETV treatment significantly improved disease severity scores including Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), and MELD sodium (MELD-Na). All ETV-treated subjects achieved an undetectable HBV DNA level (<500 copies/mL; 100 % vs. 7.9 %, p < 0.001). In univariate analysis, predictors of survival at week 48 included baseline age, total bilirubin, international normalized ratio of prothrombin time, albumin, cholesterol, receiving ETV therapy, CTP, MELD, MELD-Na, and sequential organ failure assessment (SOFA) scores. In multivariate analysis, baseline age, total bilirubin, untreated (with ETV), CTP, and SOFA scores were the independent risk factors for mortality. CONCLUSIONS: Entecavir treatment for patients with ACHBLF significantly improves disease severity scores with a marked reduction in mortality and suppression in HBV DNA to undetectable levels at week 48. Patients' age, total bilirubin, CTP, and SOFA scores at baseline are independent risk factors for higher mortality without liver transplantation.
BACKGROUND: The mortality of acute-on-chronic hepatitis B liver failure (ACHBLF) from acute exacerbation of chronic hepatitis B is 30-70 % without liver transplant. METHODS: We conducted an open-label, prospective, 48-week study to evaluate the efficacy of entecavir (ETV) in ACHBLF with 110 patients who received either ETV or no treatment. Primary measurements were survival and improvement in disease severity scores. RESULTS: Of the 110 patients enrolled, 2 withdrew consent, 108 were treated with 53 ETV, and 55 were untreated. When compared to the patients in the untreated group at week 48, a lower cumulative mortality rate in ETV-treated patients was observed [54.7 % (29/53) vs. 78.2 % (43/55), p < 0.01). ETV treatment significantly improved disease severity scores including Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), and MELD sodium (MELD-Na). All ETV-treated subjects achieved an undetectable HBV DNA level (<500 copies/mL; 100 % vs. 7.9 %, p < 0.001). In univariate analysis, predictors of survival at week 48 included baseline age, total bilirubin, international normalized ratio of prothrombin time, albumin, cholesterol, receiving ETV therapy, CTP, MELD, MELD-Na, and sequential organ failure assessment (SOFA) scores. In multivariate analysis, baseline age, total bilirubin, untreated (with ETV), CTP, and SOFA scores were the independent risk factors for mortality. CONCLUSIONS:Entecavir treatment for patients with ACHBLF significantly improves disease severity scores with a marked reduction in mortality and suppression in HBV DNA to undetectable levels at week 48. Patients' age, total bilirubin, CTP, and SOFA scores at baseline are independent risk factors for higher mortality without liver transplantation.
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