Long-term effects of telbivudine for treatment-naïve chronic hepatitis B-associated decompensated cirrhosis

Abstract

AIM: To compare the effects of telbivudine (TBV) with entecavir (ETV) on hepatitis B virus (HBV)-infected decompensated cirrhosis. METHODS: A total of 94 consecutive chronic hepatitis B patients with decompensated cirrhosis were recruited and retrospectively studied. Forty five patients were assigned to TBV group (600 mg/day) and 49 to ETV group (0.5mg/day), none of whom undertook antiviral treatment before. RESULTS: At 2 years, TBV and ETV groups had comparable cumulative rates of undetectable viremia (74.4% vs 88.0%, p = 0.083, by log-rank test) despite higher reduction of HBV-DNA levels in ETV group (-3.93 ± 0.22 vs -3.72 ± 0.24, p < 0.001). TBV and ETV groups showed comparable HBeAg clearance or seroconvertion rates, normalized alanine aminotransferase (ALT) proportions, Child-Turcotte-Pugh (CTP) and Model for end-stage liver disease (MELD) scores, cumulative rates of survival and hepatocellualr carcinoma (HCC), and proportions of cirrhosis-associated complications. TBV group had significantly higher rates of drug-resistance (15.9% vs 0%, p < 0.05) and elevated creatine kinase (CK, 18.2% vs 4.0%, p < 0.05). Cox proportional hazard regression model revealed that pretreatment HBV DNA level was the only independent predictive factor for 2-year undetectable viremia [Hazard Ratio (HR): 0.627; 95% Confidence Interval (CI): 0.432-910, p = 0.014]. CONCLUSIONS: For hepatitis B-associated decompensated cirrhosis, TBV was comparable to ETV in viral suppression, biochemical and immunological responses, and clinical outcomes. However, TBV was associated with higher rates of drug-resistance and increased CK.