title: Efficacy and safety of entecavir in patients with chronic hepatitis B and advanced hepatic fibrosis or cirrhosis.
abstract: OBJECTIVE
  The efficacy and safety of entecavir in patients with chronic hepatitis B and advanced liver fibrosis/cirrhosis was assessed from three large, randomized, multicenter, phase III studies.
  
  
  METHODS
  These studies enrolled patients (> or = 16 yr) with chronic hepatitis B, elevated alanine aminotransferase (ALT) levels, and compensated liver disease. Two trials enrolled nucleos(t)ide-naive patients randomized to at least 48 wk of treatment with entecavir 0.5 mg/day or lamivudine 100 mg/day. The third trial randomized lamivudine-refractory patients to 48 wk of entecavir 1 mg/day or lamivudine 100 mg/day. In this post hoc descriptive analysis, the efficacy and safety in patients with advanced liver fibrosis/cirrhosis (Ishak fibrosis stages 4-6) were examined for consistency with those seen in the overall study populations.
  
  
  RESULTS
  Of the 1,633 treated patients, 245 had advanced liver fibrosis/cirrhosis (120 entecavir and 125 lamivudine). Among entecavir-treated patients with advanced liver fibrosis, improvement in Ishak fibrosis was observed in 57% of nucleos(t)ide-naive hepatitis B e antigen (HBeAg)-positive patients, 59% of nucleos(t)ide-naive HBeAg-negative patients, and 43% of lamivudine-refractory HBeAg-positive patients versus 49%, 53%, and 33% of lamivudine-treated patients with advanced liver fibrosis. The overall trends in other histologic, virologic, biochemical, and serologic outcomes in entecavir- versus lamivudine-treated patients with advanced liver fibrosis/cirrhosis were consistent with those observed in the overall study populations in each trial. The treatment was well tolerated.
  
  
  CONCLUSIONS
  These data confirm that the performance of entecavir relative to that of lamivudine in patients with advanced liver fibrosis/cirrhosis was consistent with the relationship observed in the overall treated population.
authors: University of Miami, Miami, Florida, USA.
authors: Eugene
authors: E
authors: Schiff
authors: Halis
authors: H
authors: Simsek
authors: William M
authors: WM
authors: Lee
authors: You-Chen
authors: YC
authors: Chao
authors: Hoel
authors: H
authors: Sette
authors: Harry L A
authors: HL
authors: Janssen
authors: Steven-Huy
authors: SH
authors: Han
authors: Zachary
authors: Z
authors: Goodman
authors: Joanna
authors: J
authors: Yang
authors: Helena
authors: H
authors: Brett-Smith
authors: Ricardo
authors: R
authors: Tamez
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D019259:Lamivudine / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000209:etiology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D019259:Lamivudine; C413685:entecavir; D006147:Guanine