title: Effectiveness of entecavir in chronic hepatitis B NUC-naive patients in routine clinical practice.
abstract: BACKGROUND
  Registration studies showed entecavir (ETV) to be effective and safe in NUC-naïve patients with chronic hepatitis B virus (HBV), but its effectiveness in routine clinical practice is unknown.
  
  
  METHODS
  Sixty-nine HBeAg positive and negative NUC naïve chronic HBV patients were treated with ETV for 110 weeks. 63% were HBeAg positive, 16% were cirrhotics, mean HBV-DNA was 7.09 log IU/ml and mean ALT was 157 IU/ml.
  
  
  RESULTS
  Sixty-one (88%) patients achieved undetectable DNA, with 46%, 77% and 100% virological response rates at week 24, 48 and 96 of treatment, respectively. Thirty-seven (84%) patients in the HBeAg-positive population achieved undetectable DNA, with 67% and 100% virological response rates at week 48 and 96 of treatment, respectively. Twenty-four (96%) patients in the HBeAg-negative population achieved undetectable DNA, with 91% and 100% virological response rates at week 48 and 96 of treatment, respectively. Twenty-three (53%) patients cleared HBeAg and 19 (44%) patients seroconverted to antiHBe positive status; seven (10%) patients cleared hepatitis B surface antigen and five (7%) patients developed antiHBs. At the end of the study, 10 patients successfully stopped therapy: nine HBeAg positive (four developed antiHBs positive) and one HBeAg negative. None of the patients had primary non-response. ETV resistance was not tested. None of the patients developed hepatocellular carcinoma, underwent liver transplantation or died because of liver-related events. No serious adverse events were reported.
  
  
  CONCLUSIONS
  The ETV monotherapy showed high virological response rates, a favourable safety profile for NUC-naive HBeAg-positive and negative patients treated in routine clinical practice.
authors.affiliation: Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno CEMIC, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina. eridruejo@gmail.com
authors.forename: E
authors.initials: E
authors.lastname: Ridruejo
authors.forename: R
authors.initials: R
authors.lastname: Adrover
authors.forename: D
authors.initials: D
authors.lastname: Cocozzella
authors.forename: M V
authors.initials: MV
authors.lastname: Reggiardo
authors.forename: C
authors.initials: C
authors.lastname: Estepo
authors.forename: T
authors.initials: T
authors.lastname: Schroder
authors.forename: S
authors.initials: S
authors.lastname: Paz
authors.forename: M
authors.initials: M
authors.lastname: Mendizábal
authors.forename: H
authors.initials: H
authors.lastname: Fainboim
authors.forename: O G
authors.initials: OG
authors.lastname: Mandó
authors.forename: M O
authors.initials: MO
authors.lastname: Silva
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000821:virology; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine