Efficacy of telbivudine compared with entecavir in hepatitis B virus-related cirrhosis

Abstract

Background & Aims: Telbivudine (TBV) is a potent antiviralagent for the treatment of chronic HBV (Hepatitis B virus) infection. However, there is little information on the effect of TBV inchronic hepatitis B (CHB) patients with cirrhosis. Entecavir (ETV)is known to be effective for the treatment of chronic HBV infection even in patients with underlying liver cirrhosis. This study is aimed to evaluate antiviral efficacy of TBV in patients with HBV-related cirrhosis and to compare with that of ETV.

Methods: We consecutively enrolled 140 patients with HBV-related liver cirrhosis who started antiviral therapy with TBV (n=52, TBV group) or ETV (n=88, ETV group) between March 2010 and October 2011. Antiviral response was evaluated after 12 months of treatment. Virologic response (VR) was defined as an undetectable HBV DNA (< 20 IU/mL) during treatment. Improvement of liver function was assess by parameters associated with Child-Pugh score and model for end stage liver disease (MELD)in both groups.

Results: After 12 months of treatment, 65.1%(28/43) patients in TBV group and 76.8% (63/82) patients in ETV group showed VR (serum HBV DNA level <20 IU/mL)(P=0.162). Mean reductions in serum HBV DNA levels from baseline to month 12 (3.54±2.10 vs. 4.89±1.42, respectively,P=0.001) was greater in ETV group than in TBV group. In the subgroup analysis, mean changes of serum HBV DNA level was greater in ETV group (3.67±2.53 vs. 5.29±1.28, respectively, P=0.025) compared with TBV group, in both HBeAg-positive patients and HBeAg-negative patients (3.47±1.85 vs4.48±1.44, respectively, P=0.014). Four patients were reported to have antiviral resistance in the TBV group, while no resistance was reported in the ETV group. (P=0.001) However,HBeAg seroconversion, HBeAg loss, and biochemical response rates between two groups at month 12 did not differ significantly. Serum albumin, Child-Pugh score, and MELD score was significantly improved compared to pretreatment state inpatients of both groups. The change of liver function including serum albumin (0.18±0.79 vs 0.29±0.46, respectively,p=0.408), total bilirubin (-0.02±1.15 vs 0.36±1.06, respectively, p=0.118), prothrombin time (-0.08±0.12 vs -0.10±0.18,respectively, p=0.584), and Child-Pugh score (-0.55±1.75 vs -0.45±1.10, respectively, p=0.745) were not different between the TBV and ETV groups.

Conclusions: TBV therapy shows comparable effect on improvement in liver function with ETV therapy. However, degree of viral suppression during L-dT therapy is inferior to that in ETV therapy in HBV-related liver cirrhosis.