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

Mar Riveiro-Barciela, David Tabernero, José L. Calleja, Sabela Lens, María L. Manzano, Francisco Gea Rodríguez, Javier Crespo, Belén Piqueras, Juan M. Pascasio, Carmen Comas, Maria L. Gutierrez, Alberto Aguirre, Emilio Suárez, Javier García-Samaniego, Miguel Rivero, Doroteo Acero, Miguel Fernandez-Bermejo, Diego Moreno, Pilar Sánchez-Pobre, Beatriz de CuencaJ. J. Moreno-Palomares, Rafael Esteban, Maria Buti

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35 Citations (Scopus)

Abstract

© 2017, Springer Science+Business Media New York. 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.
Original languageEnglish
Pages (from-to)784-793
JournalDigestive Diseases and Sciences
Volume62
Issue number3
DOIs
Publication statusPublished - 1 Mar 2017

Keywords

  • Effectiveness
  • Entecavir
  • Hepatitis B
  • Hepatocellular carcinoma
  • Page-B
  • Safety
  • Tenofovir

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