Efficacy of telbivudine compared with entecavir in hepatitis B virus-related cirrhosis: 2 year follow-up data

Liver Int. 2015 Mar;35(3):860-9. doi: 10.1111/liv.12605. Epub 2014 Jul 5.

Abstract

Background & aims: Entecavir (ETV) is effective in the treatment of chronic hepatitis B virus (HBV) infections, even in patients with underlying cirrhosis. However, there is little information on the effect of telbivudine (TBV) in chronic hepatitis B patients with cirrhosis.This study compared the antiviral efficacy of TBV and ETV in HBV-related cirrhosis.

Methods: We consecutively enrolled 151 treatment-naïve patients with HBV-related cirrhosis who started antiviral therapy with TBV (n = 61) or ETV (n = 90).

Results: After 24 months of treatment, per-protocol analysis showed similar virological response rates (HBV DNA <20 IU/ml) in the TBV group (80.6%, 25/31) and in the ETV group (90.2%, 74/82) (P = 0.167). However, intention-to-treat analysis showed lower virological response rates in the TBV group (41.7%, 25/60) than in the ETV group (83.1%, 74/89) (P = 0.001). Mean reduction in HBV DNA levels was greater in the ETV group (-3.72 ± 1.94 vs. -4.87 ± 1.57 respectively, P = 0.001). Serologic and biochemical response rates at month 24 did not differ significantly between the groups. Child-Turcotte-Pugh score was significantly improved after 24 months compared to the pretreatment state without difference between the groups. During 24 months of therapy, 15 patients (27.3%) showed antiviral resistance to TBV while no resistance (0%) was reported in the ETV group (P = 0.001).

Conclusions: Compared to ETV, TBV therapy shows lower efficacy in viral suppression and higher risk of antiviral resistance despite comparable effect on improvement of hepatic function for the treatment of HBV-related cirrhosis.

Keywords: cirrhosis; entecavir; hepatitis B; telbivudine.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use*
  • DNA, Viral / blood
  • Drug Resistance, Viral
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Follow-Up Studies
  • Guanine / analogs & derivatives*
  • Guanine / therapeutic use
  • Hepatitis B e Antigens / blood
  • Hepatitis B virus / drug effects
  • Hepatitis B, Chronic / drug therapy*
  • Humans
  • Liver Cirrhosis / drug therapy*
  • Liver Cirrhosis / virology
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Retrospective Studies
  • Telbivudine
  • Thymidine / analogs & derivatives*
  • Thymidine / therapeutic use
  • Viral Load

Substances

  • Antiviral Agents
  • DNA, Viral
  • Hepatitis B e Antigens
  • Telbivudine
  • entecavir
  • Guanine
  • Thymidine