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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

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Abstract

Background

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.

Aims

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.

Methods

Analysis of Caucasian chronic hepatitis B subjects treated with entecavir or tenofovir from the prospective, multicenter database CIBERHEP.

Results

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.

Conclusions

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.

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Funding

CIBERHEP database is supported by BMS and Gilead.

Author information

Authors and Affiliations

  1. Liver Unit, Department of Internal Medicine, Hospital Universitari Vall d’Hebron and Universitat Autònoma de Barcelona, Passeig Vall Hebron, 119-129, 08035, Barcelona, Spain

    Mar Riveiro-Barciela, Rafael Esteban & Maria Buti

  2. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain

    Mar Riveiro-Barciela, David Tabernero, José L. Calleja, Sabela Lens, Juan M. Pascasio, Javier García-Samaniego, Rafael Esteban & Maria Buti

  3. Liver Pathology Unit, Departments of Biochemistry and Microbiology (Virology Unit), Hospital Universitari Vall d’Hebron and Universitat Autònoma de Barcelona, Barcelona, Spain

    David Tabernero

  4. Liver Unit, Hospital U. Puerta de Hierro, Universidad Autonoma de Madrid, Majadahonda, Madrid, Spain

    José L. Calleja

  5. Liver Unit, Hospital Clínic de Barcelona, IDIBAPS, Barcelona, Spain

    Sabela Lens

  6. Digestive Diseases Department, Hospital Universitario 12 de octubre, Madrid, Spain

    María L. Manzano

  7. Digestive Diseases Department, Hospital Universitario Ramón y Cajal, Madrid, Spain

    Francisco Gea Rodríguez

  8. Gastroenterology and Hepatology Unit, Hospital Universitario Valdecilla, IDIVAL, Facultad de Medicina, Santander, Spain

    Javier Crespo

  9. Digestive Diseases Department, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, Spain

    Belén Piqueras

  10. Digestive Diseases Department, Hospital Universitario Virgen del Rocío, Seville, Spain

    Juan M. Pascasio

  11. Digestive Diseases Department, Hospital Universitario Infanta Sofía, San Sebastián de los Reyes, Madrid, Spain

    Carmen Comas

  12. Digestive Diseases Department, Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain

    Maria L. Gutierrez

  13. Digestive Diseases Department, Hospital Universitario Severo Ochoa, Leganés, Madrid, Spain

    Alberto Aguirre

  14. Digestive Diseases Department, Hospital Universitario Virgen de Valme, Seville, Spain

    Emilio Suárez

  15. Liver Unit, Hospital Universitario La Paz, IdiPAZ, Madrid, Spain

    Javier García-Samaniego

  16. Digestive Diseases Department, Hospital Universitario del Sureste, Arganda del Rey, Madrid, Spain

    Miguel Rivero

  17. Digestive Diseases Department, Hospital Universitario de Girona Dr. Josep Trueta, Girona, Spain

    Doroteo Acero

  18. Digestive Diseases Department, Hospital San Pedro de Alcántara, Cáceres, Spain

    Miguel Fernandez-Bermejo

  19. Digestive Diseases Department, Hospital Universitario de Móstoles, Móstoles, Madrid, Spain

    Diego Moreno

  20. Digestive Diseases Department, Hospital Clínico San Carlos, Madrid, Spain

    Pilar Sánchez-Pobre

  21. Digestive Diseases Department, Hospital Infanta Cristina, Parla, Madrid, Spain

    Beatriz de Cuenca

  22. Internal Medicine Department, Hospital General de Segovia, Segovia, Spain

    J. J Moreno-Palomares

Authors
  1. Mar Riveiro-Barciela
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  2. David Tabernero
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  3. José L. Calleja
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  4. Sabela Lens
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  5. María L. Manzano
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  6. Francisco Gea Rodríguez
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  7. Javier Crespo
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  8. Belén Piqueras
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  9. Juan M. Pascasio
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  10. Carmen Comas
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  11. Maria L. Gutierrez
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  12. Alberto Aguirre
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  13. Emilio Suárez
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  14. Javier García-Samaniego
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  15. Miguel Rivero
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  16. Doroteo Acero
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  17. Miguel Fernandez-Bermejo
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  18. Diego Moreno
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  19. Pilar Sánchez-Pobre
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  20. Beatriz de Cuenca
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  21. J. J Moreno-Palomares
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  22. Rafael Esteban
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  23. Maria Buti
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Corresponding author

Correspondence to Maria Buti.

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Conflict of interest

Mar Riveiro-Barciela has received grants from Gilead. David Tabernero has served as speaker for Gilead. Sabela Lens has served as speaker for Gilead, Janssen and Abbvie. Jose L. Calleja has served as speaker and consultant for Gilead, BMS, MSD and Abbvie. Javier García-Samaniego has served as speaker and consultant for Gilead and BMS. Maria Buti has served as speaker for Gilead and BMS. The rest of authors declare that they have no conflict of interest.

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Riveiro-Barciela, M., Tabernero, D., Calleja, J.L. et al. 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. Dig Dis Sci 62, 784–793 (2017). https://doi.org/10.1007/s10620-017-4448-7

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  • DOI: https://doi.org/10.1007/s10620-017-4448-7

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