Efficacy of entecavir in treatment-naïve patients with hepatitis B virus-related decompensated cirrhosis

J Hepatol. 2010 Feb;52(2):176-82. doi: 10.1016/j.jhep.2009.11.007. Epub 2009 Dec 16.


Background & aims: The effect of entecavir (ETV) therapy on viral suppression and hepatic function in hepatitis B virus (HBV) patients with decompensated cirrhosis has not been established. We evaluated ETV as first-line monotherapy in these patients.

Methods: We consecutively enrolled 70 HBV-infected patients with decompensated cirrhosis primarily treated with 0.5mg/day ETV, and evaluated the clinical outcomes by intention-to-treat analyses. We also compared the virological responses of 55 patients treated for 12 months (decompensated group) with those of 144 chronic hepatitis or compensated cirrhosis patients (compensated group).

Results: The cumulative transplantation-free survival was 87.1% at 1year. ETV treatment for 12 months resulted in improved Child-Turcotte-Pugh (CTP) and model for end-stage liver disease (MELD) scores. Sixty-six percent (36/55) of patients achieved CTP class A and 49% (27/55) showed improvement in the CTP score of 2 points after 12 months of ETV. The 1-year cumulative rates of HBV DNA negativity and HBeAg loss were 92.3% and 54.0%, respectively, by intention-to-treat analysis. The rates of HBV DNA negativity, HBeAg seroconversion/loss and ALT normalization at month 12 were similar for the decompensated and compensated groups. Cox regression analysis showed that pretreatment HBeAg seropositivity was a negative predictor of HBV DNA clearance during ETV therapy (hazard ratio, 0.514; 95% confidence interval 0.367-0.719; p<0.001).

Conclusions: One-year initial ETV therapy was similarly effective in both compensated and decompensated liver disease HBV patients. In addition, it improved underlying liver function in decompensated patients.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antiviral Agents / therapeutic use*
  • DNA, Viral / blood
  • Female
  • Guanine / analogs & derivatives*
  • Guanine / therapeutic use
  • Hepatitis B / complications*
  • Hepatitis B / drug therapy*
  • Hepatitis B / physiopathology
  • Hepatitis B / virology
  • Humans
  • Kaplan-Meier Estimate
  • Liver Cirrhosis / drug therapy*
  • Liver Cirrhosis / etiology*
  • Liver Cirrhosis / physiopathology
  • Liver Function Tests
  • Liver Transplantation
  • Male
  • Middle Aged
  • Treatment Outcome


  • Antiviral Agents
  • DNA, Viral
  • entecavir
  • Guanine