Institute of Digestive Disease and Hong Kong SAR, China; Department of Medicine and Therapeutics, the Chinese University of Hong Kong; Hong Kong SAR, China.
Entecavir is a potent antiviral agent with high genetic barrier to resistance, hence 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. Entecavir cohort included consecutive CHB patients who had received entecavir 0.5 mg daily for at least 12 months. Historical control cohort included untreated patients recruited since1997 who underwent routine clinical care. The primary outcome was the 5-year cumulative probability of hepaticevents, defined as any cirrhotic complications, hepatocellular carcinoma (HCC) and/or liver-related mortality. 1446 entecavir-treated patients (72% male, age 51±12 years, follow-up for 36±13 months) and 424 treatment-naïve patients (65% male, age 41±13 years, follow-up for 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 to treatment-naïve cirrhotic patients after adjusted for MELD score: hepatic events (HR=0.51, 95%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 cirrhotic patients who failed to achieve undetectable HBV DNA (105/482, 22%) had comparable risk ofhepatic eventsas 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.).