Three years of entecavir (etv) re-treatment of HBeAg(-) etv patients who previously discontinued ETV treatment: results from study ETV-901

Abstract

Background: Entecavir (ETV) 0.5 mg was superior to lamivu-dine 100 mg for virologic, histologic and biochemical end-points at Week 48 in nucleoside-naïve HBeAg(-) chronichepatitis B (CHB) patients (ETV-027). Patients that met protocol-defined endpoints were taken off therapy after 52 weeks. Sub-jects who relapsed within 6 months could re-enroll in ETV-901.We report results of ETV re-treatment through 3 years in studyETV-901. Methods: The HBeAg(-) ETV re-treatment cohort con-sists of patients who enrolled into ETV-901 with a treatmentgap of at least 60 days between studies and received re-treat-ment with 1 mg of ETV. The proportions of patients with HBVDNA <300 copies/mL by PCR assay and ALT normalizationwere evaluated among patients with available samples at 2years (96 weeks) and 3 years (144 weeks) of ETV re-treatment.Results: Ninety-nine ETV-treated subjects from study ETV-027met criteria for ETV re-treatment and enrolled in ETV-901; 76and 66 subjects met criteria for inclusion in the analyses of 2and 3 years of ETV re-treatment, respectively. Efficacy parame-ters for patients receiving up to 3 years ETV re-treatment arepresented in the table below. After 3 years of ETV treatment,57/57 (100%) patients had HBV DNA levels <104copies/mL.The safety profile of ETV in this re-treated population was con-sistent with the previously reported experience. Conclusions:ETV-027 demonstrated that discontinuation of effective antiviraltherapy in HBeAg(-) patients after 52 weeks of treatment resultsin rebound of viremia and increases in ALT. At 3 years of ETVre-treatment, 95% of HBeAg(-) patients who had previously dis-continued ETV therapy had undetectable HBV DNA and 86%achieved ALT normalization.