title: Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B.
abstract: Sustained virologic suppression is a primary goal of therapy for chronic hepatitis B (CHB). In study entecavir (ETV)-022, 48 weeks of entecavir 0.5 mg was superior to lamivudine for virologic suppression for hepatitis B e antigen (HBeAg)-positive CHB. A total of 183 entecavir-treated patients from ETV-022 subsequently enrolled in study ETV-901. We present the results after up to 5 years (240 weeks) of continuous entecavir therapy. The entecavir long-term cohort consists of patients who received >or=1 year of entecavir 0.5 mg in ETV-022 and then entered ETV-901 with a treatment gap <or=35 days. In ETV-901 the entecavir dose was 1.0 mg daily. For patients with samples available at Year 5, proportions with hepatitis B virus (HBV) DNA <300 copies/mL, normal alanine aminotransferase (ALT) levels, HBeAg loss, and HBeAg seroconversion were determined. In all, 146 patients met criteria for inclusion in the entecavir long-term cohort. At Year 5, 94% (88/94) had HBV DNA <300 copies/mL and 80% (78/98) had normal ALT levels. In addition to patients who achieved serologic responses during study ETV-022, 23% (33/141) achieved HBeAg seroconversion and 1.4% (2/145) lost hepatitis B surface antigen (HBsAg) during study ETV-901. Through 5 years, entecavir resistance emerged in one patient. The safety profile of entecavir was consistent with previous reports.
  
  
  CONCLUSIONS
  Extended therapy with entecavir through 5 years maintained or increased rates of HBV DNA suppression and ALT normalization. Additional patients also achieved HBeAg loss and seroconversion. Entecavir provides sustained viral suppression with minimal resistance during long-term treatment of HBeAg-positive CHB.
authors.affiliation: Medical College, National Cheng Kung University, Tainan, Taiwan, ROC. ttchang@mail.ncku.edu.tw
authors.forename: Ting-Tsung
authors.initials: TT
authors.lastname: Chang
authors.forename: Ching-Lung
authors.initials: CL
authors.lastname: Lai
authors.forename: Seung
authors.initials: S
authors.lastname: Kew Yoon
authors.forename: Samuel S
authors.initials: SS
authors.lastname: Lee
authors.forename: Henrique Sergio M
authors.initials: HS
authors.lastname: Coelho
authors.forename: Flair Jose
authors.initials: FJ
authors.lastname: Carrilho
authors.forename: Fred
authors.initials: F
authors.lastname: Poordad
authors.forename: Waldemar
authors.initials: W
authors.lastname: Halota
authors.forename: Yves
authors.initials: Y
authors.lastname: Horsmans
authors.forename: Naoky
authors.initials: N
authors.lastname: Tsai
authors.forename: Hui
authors.initials: H
authors.lastname: Zhang
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Tenney
authors.forename: Ricardo
authors.initials: R
authors.lastname: Tamez
authors.forename: Uchenna
authors.initials: U
authors.lastname: Iloeje
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood*; D019694:Hepatitis B, Chronic / Q000097:blood* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine