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

• Published in: Journal of hepatology 2010-02, Vol.52 (2), p.176-182
• Main Authors: Shim, Ju Hyun, Lee, Han Chu, Kim, Kang Mo, Lim, Young-Suk, Chung, Young-Hwa, Lee, Yung Sang, Suh, Dong Jin
• Format: Article
• Language: English
• Subjects: Adult; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiviral agents; Antiviral Agents - therapeutic use; Biological and medical sciences; Decompensated cirrhosis; DNA, Viral - blood; Efficacy; Entecavir; Female; Gastroenterology and Hepatology; Gastroenterology. Liver. Pancreas. Abdomen; Guanine - analogs & derivatives; Guanine - therapeutic use; Hepatitis B - complications; Hepatitis B - drug therapy; Hepatitis B - physiopathology; Hepatitis B - virology; Hepatitis B virus; Humans; Kaplan-Meier Estimate; Liver Cirrhosis - drug therapy; Liver Cirrhosis - etiology; Liver Cirrhosis - physiopathology; Liver Function Tests; Liver Transplantation; Liver. Biliary tract. Portal circulation. Exocrine pancreas; Male; Medical sciences; Middle Aged; Other diseases. Semiology; Pharmacology. Drug treatments; Treatment Outcome
• ISSN: 0168-8278; 1600-0641
• DOI: 10.1016/j.jhep.2009.11.007

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 0.5 mg/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 1 year. 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.