title: Efficacy and safety of long term entecavir in chronic hepatitis B treatment naïve patients in clinical practice.
abstract: OBJECTIVE
  Entecavir (ETV) is effective and safe in patients with chronic hepatitis B in the short term, but its long term efficacy and safety has not been established.
  
  
  METHODS
  We evaluated HBV DNA clearance, HBeAg/antiHBe and HBsAg/antiHBs seroconversion rates in HBeAg-positive and negative NUC naïve HBV patients treated with ETV for more than 6 months, and predictors of response.
  
  
  RESULTS
  A hundred and sixty nine consecutive patients were treated with ETV for a median of 181 weeks. 61% were HBeAg positive, 23% were cirrhotics, and mean HBV-DNA levels were 6,88 ± 1,74 log10 IU/mL. Overall, 156 (92%) patients became HBV DNA undetectable, 92 (88%) HBeAg positive and 64 (98%) HBeAg negative patients. Seventy four (71%) patients cleared HBeAg after a median of 48 weeks of treatment, 23 (14%) patients cleared HBsAg (19 HBeAg positive and 4 HBeAg negative, p 0.025) after a median of 96 weeks of treatment, and 22 (13%) patients developed protective titers of anti-HBs. At the end of the study, 35 (20%) patients had discontinued therapy: 33 HBeAg positive and 2 HBeAg negative; 9 of them (26%) developed virological relapse after a median of 48 weeks of stopping treatment. None of the patients had primary non response and one patient developed breakthrough. Two patients developed HCC, three underwent liver transplantation and 3 deaths were attributable to liver-related events. No serious adverse events were reported.
  
  
  CONCLUSIONS
  Long term ETV treatment showed high virological response rates, and a favorable safety profile for NUC-naive HBeAg-positive and negative patients treated in clinical practice.
authors.affiliation: Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno "CEMIC". Ciudad Autónoma de Buenos Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario Austral. Pilar, Provincia de Buenos Aires, Argentina.
authors.forename: Ezequiel
authors.initials: E
authors.lastname: Ridruejo
authors.affiliation: Hepatology and Liver Transplant Unit, Hospital Italiano. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Sebastián
authors.initials: S
authors.lastname: Marciano
authors.affiliation: Hepatology and Liver Transplant Unit, Hospital Italiano. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Omar
authors.initials: O
authors.lastname: Galdame
authors.affiliation: Hepatology Unit, Hospital Provincial del Centenario/Sanatorio Americano. Rosario, Provincia de Santa Fe, Argentina.
authors.forename: María V
authors.initials: MV
authors.lastname: Reggiardo
authors.affiliation: Hepatology Unit, Hospital Dr. Carlos B. Udaondo. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Alberto E
authors.initials: AE
authors.lastname: Muñoz
authors.affiliation: Hepatology Unit, Centro de Hepatología. La Plata, Provincia de Buenos Aires, Argentina.
authors.forename: Raúl
authors.initials: R
authors.lastname: Adrover
authors.affiliation: Hepatology Unit, Centro de Hepatología. La Plata, Provincia de Buenos Aires, Argentina.
authors.forename: Daniel
authors.initials: D
authors.lastname: Cocozzella
authors.affiliation: Hepatology Unit, Hospital Británico. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Nora
authors.initials: N
authors.lastname: Fernandez
authors.affiliation: Hepatology Unit, Hospital Francisco J. Muñiz. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Claudio
authors.initials: C
authors.lastname: Estepo
authors.affiliation: Hepatology and Liver Transplant Unit, Hospital Universitario Austral. Pilar, Provincia de Buenos Aires, Argentina.
authors.forename: Manuel
authors.initials: M
authors.lastname: Mendizabal
authors.affiliation: Hepatology Unit, Hospital Dr. Carlos B. Udaondo. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Gustavo A
authors.initials: GA
authors.lastname: Romero
authors.affiliation: Hepatology Unit, Hospital Dr. Carlos B. Udaondo. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Diana
authors.initials: D
authors.lastname: Levi
authors.affiliation: Hepatology Unit, Hospital Francisco J. Muñiz. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Teresa
authors.initials: T
authors.lastname: Schroder
authors.affiliation: Hepatology Unit, Hospital Francisco J. Muñiz. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Silvia
authors.initials: S
authors.lastname: Paz
authors.affiliation: Hepatology Unit, Hospital Francisco J. Muñiz. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Hugo
authors.initials: H
authors.lastname: Fainboim
authors.affiliation: Hepatology Section, Department of Medicine, Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno "CEMIC". Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Oscar G
authors.initials: OG
authors.lastname: Mandó
authors.affiliation: Hepatology and Liver Transplant Unit, Hospital Italiano. Ciudad Autónoma de Buenos Aires, Argentina.
authors.forename: Adrián C
authors.initials: AC
authors.lastname: Gadano
authors.affiliation: Hepatology and Liver Transplant Unit, Hospital Universitario Austral. Pilar, Provincia de Buenos Aires, Argentina.
authors.forename: Marcelo O
authors.initials: MO
authors.lastname: Silva
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D004279:DNA, Viral / Q000097:blood*; D005260:Female; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006510:Hepatitis B Antibodies / Q000276:immunology; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006513:Hepatitis B e Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008103:Liver Cirrhosis / Q000209:etiology / Q000601:surgery; D016031:Liver Transplantation; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine