title: Efficacy and safety of entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients.
abstract: BACKGROUND
  Entecavir is an effective treatment for chronic hepatitis B. However, data from clinical practice are limited, especially in hepatitis B e antigen (HBeAg)-positive patients.
  
  
  METHODS
  We retrospectively analysed data from 190 nucleos(t)ide-naive chronic hepatitis B patients treated with entecavir (0.5 mg/day) in 25 Spanish centres. Virological response (hepatitis B virus DNA <50 IU/ml by PCR), biochemical response (alanine aminotransferase ≤ 1 × upper limit of normal) and serological response were assessed at weeks 12, 24, 36 and 48.
  
  
  RESULTS
  The cohort was 73% male, 84% Caucasian, and 30% HBeAg-positive. Thirty-four per cent of the patients who underwent biopsy had advanced fibrosis/cirrhosis. At baseline, the median hepatitis B virus DNA was 5.94 (interquartile range=4.64-7.39) log10 IU/ml. At week 48, 83% of the patients (61% HBeAg-positive; 92% HBeAg-negative) achieved a virological response and 82% (78% HBeAg-positive; 83% HBeAg-negative) of those with elevated baseline alanine aminotransferase showed a biochemical response. Twenty-six per cent (14/54) of the HBeAg-positive patients lost HBeAg and 22% (12/54) achieved seroconversion to anti-HBe. A significant correlation was observed between virological response at week 12 and the rate of seroconversion to anti-HBe at week 48 (P=0.039). This correlation was also noted at weeks 24, 36 and 48 (P=0.003, 0.002 and 0.017, respectively). Three patients (2%) showed clearance of hepatitis B surface antigen. No resistance to entecavir was observed. Treatment with entecavir was generally well tolerated. No patients discontinued treatment due to adverse events.
  
  
  CONCLUSIONS
  Entecavir monotherapy in clinical practice was well tolerated and resulted in a rapid and significant reduction in viral load. A virological response at week 12 correlated significantly with the rate of seroconversion to anti-HBe at week 48.
authors.affiliation: CIBER on Liver and Digestive Diseases, Hospital Vall d'Hebron, [corrected] Barcelona, Spain. mbuti@vhebron.net
authors.forename: María
authors.initials: M
authors.lastname: Buti
authors.forename: Rosa Maria
authors.initials: RM
authors.lastname: Morillas
authors.forename: Martín
authors.initials: M
authors.lastname: Prieto
authors.forename: Moisés
authors.initials: M
authors.lastname: Diago
authors.forename: Juan
authors.initials: J
authors.lastname: Pérez
authors.forename: Ricard
authors.initials: R
authors.lastname: Solà
authors.forename: Lucía
authors.initials: L
authors.lastname: Bonet
authors.forename: Antonio
authors.initials: A
authors.lastname: Palau
authors.forename: Milagros
authors.initials: M
authors.lastname: Testillano
authors.forename: Javier
authors.initials: J
authors.lastname: García-Samaniego
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004341:Drug Evaluation / Q000379:methods; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine