Telbivudine versus lamivudine and entecavir for treatment-naïve decompensated hepatitis B virus-related cirrhosis.

Abstract

The long-term effects of telbivudine (TBV) on decompensated hepatitis B virus (HBV)-related cirrhosis were still not established. This study aimed to investigate the efficacy and safety of TBV in such cohort of patients as compared to lamivudine (LAM) and entecavir (ETV). We retrospectively evaluated 130 treatment-naïve patients with HBV-related decompensated cirrhosis who started treatment with TBV (n=31), LAM (n=45) or ETV (n=54). After 24months of treatment, cumulative virological response (VR) rates (HBV DNA <500copies/mL) were 83.7, 65.3 and 89.1% in TBV, LAM and ETV groups, respectively (p=0.009). Reduction in HBV DNA levels in TBV was -3.66±0.56, significantly higher than LAM (-3.34±0.59; p<0.05) and lower than ETV group (-3.98±0.52; p<0.05). The rates of HBeAg loss or seroconversion and normalization of alanine aminotransferase (ALT) were similar among the groups. Child-Turcotte-Pugh (CTP) score and model for end-stage liver disease score in TBV were significantly improved compared to at baseline without difference among the groups. TBV resulted in similar cumulative rates of survival and incidence of hepatocellular carcinoma (HCC) to LAM and ETV. Frequencies of complications from cirrhosis, including variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis, were comparable among the groups. Four patients (16.7%) in TBV displayed virological breakthrough, lower than LAM and higher than ETV (p=0.004). Cox regression analysis showed that baseline HBV DNA (hazard ratio 0.743; 95% confidence interval 0.582-949, p=0.017) was an independent predictor for VR at 24months. Long-term therapy with TBV was effective and safe in HBV-related decompensated cirrhosis.