Long-term entecavir therapy results in reversal of fibrosis/cirrhosis and continued histologic improvement in patients with HBeAg(+) and (-) chronic hepatitis B: results from studies ETV-022, -027 and -901

Background: Entecavir (ETV) 0.5 mg resulted in improved liverhistology and was superior to lamivudine at 1 year in studiesETV-022 and ETV-027 (HBeAg(+) and (-) nucleoside-naïvepatients, respectively).1,2We present long term histologic resultsfor a subset of patients treated with ETV for a median of 6years. Methods: The long-term histology cohort consists of ETV-treated patients who completed study -022 or -027, subse-quently received ETV 1 mg daily in ETV-901, had an evaluablebiopsy at baseline (-022, -027) and had ≥3 years of cumulative ETV therapy (from phase III baseline to -901). Co-primary his-tology endpoints were proportions with histologic improvement(≥2-point decrease in Knodell necroinflammatory score and noworsening of Knodell fibrosis score) and improvement in Ishakfibrosis score (≥1 point decrease) compared to baseline. Keysecondary endpoints included proportions with HBV DNA