title: Efficacy and safety of entecavir in nucleoside-naive, chronic hepatitis B patients: phase II clinical study in Japan.
abstract: OBJECTIVE
  Entecavir has demonstrated clinical efficacy for chronic hepatitis B. This study evaluated the efficacy and safety of entecavir in nucleoside-naive Japanese chronic hepatitis B patients.
  
  
  METHODS
  In this multicenter, double-blind study, 66 nucleoside-naive Japanese chronic hepatitis B patients were randomized to 0.1 mg entecavir (n = 32) or 0.5 mg entecavir (n = 34) daily for 52 weeks. The primary endpoint was the proportion of patients whose serum hepatitis B virus (HBV) DNA decreased from baseline by > or =2 log(10) copies/mL or became undetectable (<400 copies/mL by polymerase chain reaction assay) at week 48.
  
  
  RESULTS
  One hundred percent of patients in both treatment groups achieved the primary efficacy endpoint, with 81% and 68% of patients achieving undetectable HBV DNA in the 0.1 mg and 0.5 mg treatment groups, respectively. Mean changes from baseline in HBV DNA were -4.49 log(10) and -4.84 log(10) copies/mL for the 0.1 mg and 0.5 mg groups, respectively. Significant improvements in necroinflammation were seen in both groups, as assessed by Knodell and New Inuyama classifications. Most adverse events were transient and classified as grade 1 or 2. There were no clinically significant differences in adverse events across the two treatment groups and no discontinuations due to adverse events in either group.
  
  
  CONCLUSIONS
  In Japanese nucleoside-naive patients with chronic hepatitis B, 0.1 mg or 0.5 mg entecavir daily provided excellent efficacy and was well tolerated. The 0.5 mg dose was selected for the treatment of nucleoside-naive patients.
authors.affiliation: Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan. hkobashi@md.okayama-u.ac.jp
authors.forename: Haruhiko
authors.initials: H
authors.lastname: Kobashi
authors.forename: Kouichi
authors.initials: K
authors.lastname: Takaguchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Ikeda
authors.forename: Osamu
authors.initials: O
authors.lastname: Yokosuka
authors.forename: Mitsuhiko
authors.initials: M
authors.lastname: Moriyama
authors.forename: Fumio
authors.initials: F
authors.lastname: Imazeki
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Kage
authors.forename: Taku
authors.initials: T
authors.lastname: Seriu
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Kousaku
authors.initials: K
authors.lastname: Sakaguchi
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Shiratori
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D004279:DNA, Viral / Q000097:blood; D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D007564:Japan; D008099:Liver / Q000187:drug effects / Q000473:pathology / Q000821:virology; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine