Abstract

INTRODUCTION: The aim of this study was to determine the efficacy and safety of long term entecavir monotherapy in patients with HBV-related compensated cirrhosis(HBV-RC) in Turkey.

METHODS: We performed a retrospective analysis of data from 102 adult patients with HBV-RC, beginning in 2013,at single center throughout Turkey. Baseline demographic characteristics, laboratory and clinical outcomes were recorded at yearly intervals. Patients with cirrhosis, hepatocellular carcinoma, pregnant or in lactation, and co-infected with hepatitis C, D or human immunodeficiency virus were excluded. Baseline liver biopsy was performed in 56% of the patients.

RESULTS: In this study, 102 HBV-RC patients receiving entecavir therapy were included. Average age was 48±7 years, 100% of patients were naive, 21% of patients were HBeAg positive and 55% were male. Mean follow-up was 32 ±13 months. Mean histopathologic activity index were 14 and fibrosis scores were 5.5 (according to ishak score). Baseline mean ALT and HBV DNA levels were 65 U/L and 4.3 log10 copies/mL, respectively. At the end of the 1st,2nd,3rd,4th, and 5th years of therapy, HBV DNA < 50 copies/mL was 90, 99, 100, 100 and 100 %; ALT normalization was 85, 83, 90, 100, and 98% respectively. HBsAg loss and HBsAg seroconversion were detected in 3 patients. No adverse effects were determined for withdrawal of durg. Age, sex, baseline serum ALT, HBV DNA levels, and HBeAg positivity were not associated with maintained virological suppression. In the follow-up, 8 patients died (non related liver disease), 1 patient developed hepatocellular cancer and 2 patients underwent liver transplantation.

CONCLUSION: Entecavir is effective and safe for long-term use in patients with HBV-related compensated cirrhosis in Turkey.