Entecavir has high efficacy and safety in white patients with chronic hepatitis B and comorbidities

Maria Buti, Rosa M. Morillas, Juan Pérez, Martín Prieto, Ricard Solà, Antonio Palau, Moisés Diago, Lucía Bonet, Adolfo Gallego, Javier García-Samaniego, Milagros Testillano, Manuel Rodríguez, Gregorio Castellano, María L. Gutiérrez, Manuel Delgado, Antoni Mas, Manuel Romero-Gómez, José L. Calleja, Agustina González-Guirado, Juan I. ArenasLuisa García-Buey, Raúl Andrade, Ana Gila, Edurne Almandoz, Mari Alonso, Maria Alonso Burgal, Rafael Esteban, Conrado Fernández, Rocío Gallego, Cristina Gely Vila, Dolors Giménez, Maca Gómez, Alexandra Gómez García, María Luisa González-Diéguez, Antonio Madejón, María Luisa Manzano, Inmaculada Moreno Herrera, Carmen A. Navascués, Ramon Planas, Juan Carlos Porres Cubero, Ioana Riaño Fernández, Javier Salmerón, José María Sánchez-Tapias, Roser Sotelo, Carmen Vinaixa

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2 Citations (Scopus)

Abstract

© 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins. Objectives: 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. Conclusion: 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.
Original languageEnglish
Pages (from-to)46-54
JournalEuropean Journal of Gastroenterology and Hepatology
Volume27
Issue number1
DOIs
Publication statusPublished - 11 Jan 2015

Keywords

  • Chronic hepatitis B
  • Clinical practice
  • Comorbidity
  • Drug safety
  • Entecavir

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