title: Effectiveness and Safety of Entecavir or Tenofovir in a Spanish Cohort of Chronic Hepatitis B Patients: Validation of the Page-B Score to Predict Hepatocellular Carcinoma.
abstract: Long-term antiviral therapy has resulted in viral suppression and biochemical response in chronic hepatitis B, although the risk of hepatocellular carcinoma has not been abolished. The Page-B score could be useful to estimate the probability of HCC.
  
  
  
  To analyze the effectiveness and safety of entecavir or tenofovir for more than 4 years and the usefulness of Page-B score in the real-world setting.
  
  
  
  Analysis of Caucasian chronic hepatitis B subjects treated with entecavir or tenofovir from the prospective, multicenter database CIBERHEP.
  
  
  
  A total of 611 patients were enrolled: 187 received entecavir and 424 tenofovir. Most were men, mean age 50 years, 32% cirrhotic and 16.5% HBeAg-positive. Mean follow-up was 55 (entecavir) and 49 (tenofovir) months. >90% achieved HBV DNA <69 IU/mL and biochemical normalization by months 12 and 36, respectively. Cumulative HBeAg loss and anti-HBe seroconversion were achieved by 33.7 and 23.8%. Four patients lost HBsAg; three HBeAg-positive. Renal function remained stable on long-term follow-up. Fourteen (2.29%) developed HCC during follow-up all of them with baseline Page-B ≥10. Nine were diagnosed within the first 5 years of therapy. This contrasts with the 27 estimated by Page-B, a difference that highlights the importance of regular HCC surveillance even in patients with virological suppression.
  
  
  
  Entecavir and tenofovir achieved high biochemical and virological response. Renal function remained stable with both drugs. A Page-B cut-off ≥10 selected all patients at risk of HCC development.
authors.affiliation: Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
authors.forename: Mar
authors.initials: M
authors.lastname: Riveiro-Barciela
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.|Liver Pathology Unit, Departments of Biochemistry and Microbiology (Virology Unit), Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Barcelona, Spain.
authors.forename: David
authors.initials: D
authors.lastname: Tabernero
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.|Liver Unit, Hospital U. Puerta de Hierro, Universidad Autonoma de Madrid, Majadahonda, Madrid, Spain.
authors.forename: José L
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.|Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain.
authors.forename: Sabela
authors.initials: S
authors.lastname: Lens
authors.affiliation: Digestive Diseases Department, Hospital Universitario 12 de octubre, Madrid, Spain.
authors.forename: María L
authors.initials: ML
authors.lastname: Manzano
authors.affiliation: Digestive Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
authors.forename: Francisco Gea
authors.initials: FG
authors.lastname: Rodríguez
authors.affiliation: Gastroenterology and Hepatology Unit, Hospital Universitario Valdecilla, IDIVAL, Facultad de Medicina, Santander, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Crespo
authors.affiliation: Digestive Diseases Department, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Piqueras
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.|Digestive Diseases Department, Hospital Universitario Virgen del Rocío, Seville, Spain.
authors.forename: Juan M
authors.initials: JM
authors.lastname: Pascasio
authors.affiliation: Digestive Diseases Department, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Comas
authors.affiliation: Digestive Diseases Department, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Gutierrez
authors.affiliation: Digestive Diseases Department, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Aguirre
authors.affiliation: Digestive Diseases Department, Hospital Universitario Virgen de Valme, Seville, Spain.
authors.forename: Emilio
authors.initials: E
authors.lastname: Suárez
authors.affiliation: Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.|Liver Unit, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: García-Samaniego
authors.affiliation: Digestive Diseases Department, Hospital Universitario del Sureste, Arganda del Rey, Madrid, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Rivero
authors.affiliation: Digestive Diseases Department, Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain.
authors.forename: Doroteo
authors.initials: D
authors.lastname: Acero
authors.affiliation: Digestive Diseases Department, Hospital San Pedro de Alcántara, Cáceres, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Fernandez-Bermejo
authors.affiliation: Digestive Diseases Department, Hospital Universitario de Móstoles, Móstoles, Madrid, Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Moreno
authors.affiliation: Digestive Diseases Department, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Sánchez-Pobre
authors.affiliation: Digestive Diseases Department, Hospital Infanta Cristina, Parla, Madrid, Spain.
authors.forename: Beatriz
authors.initials: B
authors.lastname: de Cuenca
authors.affiliation: Internal Medicine Department, Hospital General de Segovia, Segovia, Spain.
authors.forename: J J
authors.initials: JJ
authors.lastname: Moreno-Palomares
authors.affiliation: Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Esteban
authors.affiliation: Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d'Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain. mbuti@vhebron.net.|Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain. mbuti@vhebron.net.
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006513:Hepatitis B e Antigens / Q000032:analysis; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D008113:Liver Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D012107:Research Design / Q000592:standards; D018570:Risk Assessment / Q000379:methods*; D013030:Spain / Q000453:epidemiology; D000068698:Tenofovir / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir
keywords: Effectiveness; Entecavir; Hepatitis B; Hepatocellular carcinoma; Page-B; Safety; Tenofovir