Z Gastroenterol 2008; 46 - P446
DOI: 10.1055/s-0028-1089821

Four-Year Entecavir Treatment in Nucleoside-Naïve HBeAg(+) Patients: Results from Studies ETV-022 and -901

S Han 1, T Chang 2, YC Chao 3, SK Yoon 4, RG Gish 5, H Cheinquer 6, FJ Carrilho 7, H Zhang 8, H Brett-Smith 8, N Spiegelmacher 9, A Schwendel 9, T Pichl 9, I Reeb 9, R Hindes 8
  • 1Division of Digestive Disease, UCLA School Of Medicine, LA, United States of America
  • 2National Cheng Kung University Medical College, Tainan, Taiwan, Republic of China
  • 3Tri-Service General Hospital, Taipei, Taiwan, Republic of China
  • 4Kangnam St. Mary's Hospital, Seoul, Korea, Democratic People's Republic of
  • 5California Pacific Medical Center, San Francisco, United States of America
  • 6Universidade Federal Do Rio Grande Do Sul, Porto Alegre, Brazil
  • 7University of São Paulo School of Medicine, Department of Gastroenterology, Sao Paulo, Brazil
  • 8Bristol-Myers Squibb, Research and Development, Wallingford, United States of America
  • 9Bristol-Myers Squibb, München, Germany

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.