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Long-Term Entecavir Represses Hepatitis B Virus in Group of Patients: Presented at AASLD By Maria Bishop BOSTON, MA -- November 7, 2007 -- Continuous treatment with entecavir for 4 years achieved sustained suppression of hepatitis B virus (HBV) in the serum deoxyribonucleic acid (DNA) of nucleoside-naïve patients who are hepatitis B e antigen-positive (HBeAg+), researchers reported here at the 58th Annual Scientific Meeting of the American Association for the Study of Liver Disease (AASLD). Of the 108 HBeAg+ patients in this study who had measurements taken at week 192, 91% had undetectable HBV DNA (< 300 copies/mL), noted Steven-Huy B. Han, MD, Associate Professor of Medicine, Division of Digestive Diseases, University of California at Los Angeles (UCLA) School Of Medicine, and Director, Liver/Hepatitis Clinic, West Los Angeles Veterans Administration Medical Center Los Angeles, California, United States. Continuous treatment with entecavir also resulted in the maintenance of alanine aminotransferase (ALT) normalisation (86% at week 192 in the same cohort). Dr. Han led this long-term study, in which patients were treated with entecavir in a blinded trial (ETV-022) for 96 weeks, and then, after a gap in treatment of 35 days or less, were enrolled into study ETV-901 (combined entecavir 1 mg and lamivudine 100 mg/day). The ETV-901 protocol was subsequently changed to monotherapy only (entecavir 1 mg/daily). A total of 108 of 146 patients in the 4-Year cohort had HBV DNA measurements taken by polymerase chain reaction at Week 192. Of these, only 10 patients had HBV DNA copies greater than 300 copies/mL at week 192. One patient in this cohort developed resistance to entecavir. The safety profile was consistent with previously reported experience (ie, 90% of patients experienced an adverse event; 13% experienced a serious adverse event). Treatment during years 3 and 4 resulted in additional patients achieving ABeAg loss and seroconversion, Dr. Han noted. This trial was sponsored by Bristol-Myers Squibb. [Presentation title: Four-Year Entecavir Treatment in Nucleoside-Naïve, HBeAg(+) Patients: Results From Studies ETV-022 and -901. Abstract 938] E-mail this page to a friend or colleague! To print, use this version