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.
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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)
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Chemical References |
- Antiviral Agents
- DNA, Viral
- entecavir
- Guanine
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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
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