BACKGROUND & AIMS: Long-term treatment with entecavir resulted in durable virologic suppression and continued histologic improvement in nucleoside-na�ve chronic hepatitis B patients. Patients with advanced fibrosis or cirrhosis, who received long-term entecavir treatment, were evaluated for improvement in liver histology.
METHODS: The study included a subset of patients from phase III and long-term rollover studies, who received entecavir for at least 3 years, had advanced fibrosis or cirrhosis and evaluable biopsies at baseline and after long-term treatment.
RESULTS: Ten patients had advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score ≥4). Following approximately 6 years of cumulative entecavir therapy (range: 267-297 weeks), all 10 patients demonstrated improvement in liver histology and Ishak fibrosis score. The mean change from baseline in Ishak fibrosis and Knodell necroinflammatory scores were -2.2 and -7.6, respectively. A reduction in Ishak fibrosis score to ≤4 was observed for all four patients who had cirrhosis at baseline.
CONCLUSIONS: Chronic hepatitis B patients with advanced fibrosis or cirrhosis demonstrated histologic improvement and reversal of fibrosis and cirrhosis following long-term treatment with entecavir.