G. Wong, H. Chan, C. W. Mak
Nov 1, 2013
Citations
12
Influential Citations
425
Citations
Quality indicators
Journal
Hepatology
Abstract
Entecavir is a potent antiviral agent with high genetic barrier to resistance, hence it is currently recommended as first‐line antiviral therapy for chronic hepatitis B (CHB). The aim of this study was to investigate the efficacy of entecavir on clinical outcomes and deaths. It was a retrospective‐prospective cohort study based on two cohorts of patients. The entecavir cohort included consecutive CHB patients who had received entecavir 0.5 mg/day for at least 12 months. The historical control cohort included untreated patients recruited since 1997 who underwent routine clinical care. The primary outcome was the 5‐year cumulative probability of hepatic events, defined as any cirrhotic complications, hepatocellular carcinoma (HCC), and/or liver‐related mortality. A total of 1,446 entecavir‐treated patients (72% men; age, 51 ± 12 years; follow‐up, 36 ± 13 months) and 424 treatment‐naïve patients (65% men; age, 41 ± 13 years; follow‐up, 114 ± 31 months) were studied. Overall, there was no difference in hepatic events between the entecavir and control cohorts. Among patients with liver cirrhosis (482 entecavir‐treated, 69 treatment‐naïve), entecavir‐treated patients had reduced risks of all clinical outcomes when compared with treatment‐naïve patients with cirrhosis after adjusted for model for end‐stage liver disease score: hepatic events (hazard ratio [HR], 0.51; 95% confidence interval [CI], 0.34‐0.78; P = 0.002), HCC (HR, 0.55; 95% CI, 0.31‐0.99; P = 0.049), liver‐related mortality (HR, 0.26; 95% CI, 0.13‐0.55; P < 0.001), and all‐cause mortality (HR, 0.34; 95% CI, 0.18‐0.62; P < 0.001). Entecavir‐treated patients with cirrhosis who failed to achieve undetectable hepatitis B virus DNA (105/482 [22%]) had comparable risk of hepatic events as the untreated patients. Conclusion: Entecavir therapy reduces the risks of hepatic events, HCC, liver‐related and all‐cause mortality of CHB patients with liver cirrhosis in 5 years, particularly among those who had maintained viral suppression. (Hepatology 2013;58:1537–1547)