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

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 ⩾12months (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 12months 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 12months 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.

Keywords: Entecavir, Efficacy, Hepatitis B virus, Decompensated cirrhosis

Abbreviations: HBV, hepatitis B virus, CHB, chronic hepatitis B, HCC, hepatocellular carcinoma, LAM, lamivudine, ETV, entecavir, ALT, alanine aminotransferase, PT, prothrombin time, CTP score, Child–Turcotte–Pugh score, MELD score, model for end-stage liver disease, OLT, orthotopic liver transplantation