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DOI: 10.1055/s-0028-1089821
Four-Year Entecavir Treatment in Nucleoside-Naïve HBeAg(+) Patients: Results from Studies ETV-022 and -901
Aims: Entecavir (ETV) 0.5mg demonstrated superior virologic suppression compared to lamivudine (LVD) 100mg in study ETV-022. One hundred and eighty-three entecavir-treated patients from ETV-022 enrolled in rollover study ETV-901. We present efficacy and safety results in a cohort of patients from ETV studies -022 and -901 who received a total of 4 years of therapy with ETV.
Methods: The nucleoside-naïve HBeAg(+) 4-year cohort consists of ETV patients who completed ETV-022 and enrolled into ETV-901 with a treatment gap ≤35 days. In ETV-901, patients were treated with 1mg of ETV. The proportions of patients with HBV DNA < 300 copies/mL by PCR assay, ALT normalization, HBeAg loss or HBeAg seroconversion were evaluated among patients with available samples at week 192.
Results: The nucleoside-naïve HBeAg(+) 4-year ETV treatment cohort consists of 146 patients. Efficacy parameters through 4 years of ETV therapy are presented below.
HBV DNA< 300 copies/mL, n (%): 98/108 (91)
ALT ≤1 x ULN – number (%): 96/112 (86)
HBeAg loss – number (%): 39/96 (41)
HBeAg seroconversion – number (%): 15/96 (16)
The safety profile of ETV was consistent with previously reported experience.
Conclusions: At Wk 192, 91% of patients who received ETV treatment during 4 years achieved undetectable HBV-DNA and 86% had ALT normalization, with patients continuing to experience HBeAg loss and HBeAg seroconversion during Years 3 and 4. The safety profile was consistent with previously reported experience.