title: Entecavir has high efficacy and safety in white patients with chronic hepatitis B and comorbidities.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety of entecavir monotherapy in nucleos(t)ide-naive chronic hepatitis B patients and to analyse the influence of the comorbidity burden on therapy outcome.
  
  
  METHODS
  We retrospectively analysed data from 237 nucleos(t)ide-naive chronic hepatitis B white patients treated with entecavir (0.5 mg/day) at 23 Spanish centres. For the efficacy and safety analyses, patients were grouped according to their baseline comorbidities.
  
  
  RESULTS
  The mean age of the cohort was 43 years (range: 19-82 years); 73% were male, 83% were white, and 33% were hepatitis B e antigen (HBeAg) positive. At baseline, the median hepatitis B virus DNA level was 6.20 log10 IU/ml. Of the patients, 18% had cirrhosis, 9.7% had diabetes, 16.3% had hypertension, and 15.7% had obesity; 13.4% of patients had more than one comorbid condition. Virological and biochemical responses at month 36 were obtained independently of the patients' baseline comorbid condition. Of 10 HBeAg-positive patients who discontinued treatment after HBeAg seroconversion, those who had not also cleared HBsAg (six) experienced virological recurrence in a median 5.6 months. There were no treatment discontinuations due to adverse events. Three patients were diagnosed with hepatocellular carcinoma at months 12, 30 and 54, and six experienced hepatic decompensation during follow-up. The median serum creatinine levels did not increase after 36 months of treatment, even in patients with comorbidities.
  
  
  CONCLUSIONS
  Entecavir is safe, well tolerated, and highly effective, even in patients with comorbid condition(s). Discontinuation of treatment in patients who have not been cleared of HBsAg may lead to virological recurrence.
authors.affiliation: aCIBER on Liver and Digestive Diseases (CIBERehd), Hospital Vall d'Hebron bHospital del Mar, IMIM, Universitat Autònoma de Barcelona cHospital de la Santa Creu i Sant Pau dHospital Clínic, Barcelona eCIBERehd H. La Fe, Hospital General Universitario de Castellón, Castellón fHospital Son Espases, Palma de Mallorca gCIBERehd, Hospital Universitari Germans Trias i Pujol, Badalona hCIBERehd, Hospital Carlos III iHospital Universitario 12 de Octubre jHospital Puerta del Hierro kFundación Jiménez Díaz lCIBERehd, Hospital Universitario La Princesa, Madrid mHospital de Cruces, Bizkaia nHospital Virgen Macarena oCIBERehd, Hospital Universitario de Valme, Sevilla pHospital Central de Asturias, Oviedo qHospital Universitario Fundación Alcorcón, Alcorcón rHospital Universitario de La Coruña, A Coruña sHospital Universitario Donostia, Donostia tCIBERehd, Hospital Universitario y Politécnico La Fe uHospital General Universitario de Valencia, Valencia vCIBERehd, Hospital Virgen de la Victoria, Málaga wHospital Universitario San Cecilio, Granada, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Rosa M
authors.initials: RM
authors.lastname: Morillas
authors.forename: Juan
authors.initials: J
authors.lastname: Pérez
authors.forename: Martín
authors.initials: M
authors.lastname: Prieto
authors.forename: Ricard
authors.initials: R
authors.lastname: Solà
authors.forename: Antonio
authors.initials: A
authors.lastname: Palau
authors.forename: Moisés
authors.initials: M
authors.lastname: Diago
authors.forename: Lucía
authors.initials: L
authors.lastname: Bonet
authors.forename: Adolfo
authors.initials: A
authors.lastname: Gallego
authors.forename: Javier
authors.initials: J
authors.lastname: García-Samaniego
authors.forename: Milagros
authors.initials: M
authors.lastname: Testillano
authors.forename: Manuel
authors.initials: M
authors.lastname: Rodríguez
authors.forename: Gregorio
authors.initials: G
authors.lastname: Castellano
authors.forename: María L
authors.initials: ML
authors.lastname: Gutiérrez
authors.forename: Manuel
authors.initials: M
authors.lastname: Delgado
authors.forename: Antoni
authors.initials: A
authors.lastname: Mas
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero-Gómez
authors.forename: José L
authors.initials: JL
authors.lastname: Calleja
authors.forename: Agustina
authors.initials: A
authors.lastname: González-Guirado
authors.forename: Juan I
authors.initials: JI
authors.lastname: Arenas
authors.forename: Luisa
authors.initials: L
authors.lastname: García-Buey
authors.forename: Raúl
authors.initials: R
authors.lastname: Andrade
authors.forename: Ana
authors.initials: A
authors.lastname: Gila
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003404:Creatinine / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D003920:Diabetes Mellitus; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D006513:Hepatitis B e Antigens / Q000276:immunology; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000097:blood / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D006973:Hypertension / Q000150:complications; D008103:Liver Cirrhosis / Q000150:complications; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications; D012008:Recurrence; D012189:Retrospective Studies; D044465:White People; D055815:Young Adult
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; D003404:Creatinine; D000410:Alanine Transaminase