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

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.
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).
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).
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.
AuthorsJu Hyun Shim, Han Chu Lee, Kang Mo Kim, Young-Suk Lim, Young-Hwa Chung, Yung Sang Lee, Dong Jin Suh
JournalJournal of hepatology (J Hepatol) Vol. 52 Issue 2 Pg. 176-82 (Feb 2010) ISSN: 1600-0641 [Electronic] England
PMID20006394 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antiviral Agents
  • DNA, Viral
  • entecavir
  • Guanine
  • Adult
  • Antiviral Agents (therapeutic use)
  • DNA, Viral (blood)
  • Female
  • Guanine (analogs & derivatives, therapeutic use)
  • Hepatitis B (complications, drug therapy, physiopathology, virology)
  • Humans
  • Kaplan-Meier Estimate
  • Liver Cirrhosis (drug therapy, etiology, physiopathology)
  • Liver Function Tests
  • Liver Transplantation
  • Male
  • Middle Aged
  • Treatment Outcome

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