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

Abstract

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.

• Authors: Ju Hyun Shim, Han Chu Lee, Kang Mo Kim, Young-Suk Lim, Young-Hwa Chung, Yung Sang Lee, Dong Jin Suh
• Journal: Journal of hepatology (J Hepatol) Vol. 52 Issue 2 Pg. 176-82 (Feb 2010) ISSN: 1600-0641 [Electronic] Netherlands
• PMID: 20006394 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• DNA, Viral
• entecavir
• Guanine

Topics

• 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