Entecavir has high efficacy and safety in white patients with chronic hepatitis B and comorbidities
Por:
Buti, M, Morillas, RM, Perez, J, Prieto, M, Sola, R, Palau, A, Diago, M, Bonet, L, Gallego, A, Garcia-Samaniego, J, Testillano, M, Rodriguez, M, Castellano, G, Gutierrez, ML, Delgado, M, Mas, A, Romero-Gomez, M, Calleja, JL, Gonzalez-Guirado, A, Arenas, JI, Garcia-Buey, L, Andrade, R, Gila, A
Publicada:
1 ene 2015
Resumen:
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. (C) 2014 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins.
Filiaciones:
Buti, M:
Univ Autonoma Barcelona, Hosp Vall dHebron, CIBER Liver & Digest Dis CIBERehd, E-08193 Barcelona, Spain
Morillas, RM:
Hosp Badalona Germans Trias & Pujol, CIBERehd, Badalona, Spain
Perez, J:
Hosp Virgen Macarena, Seville, Spain
Prieto, M:
Hosp Univ & Politecn La Fe, CIBERehd, Valencia, Spain
Sola, R:
Univ Autonoma Barcelona, Hosp del Mar, IMIM, E-08193 Barcelona, Spain
Palau, A:
Univ Castellon, Gen Hosp, CIBERehd H La Fe, Castellon de La Plana, Spain
Diago, M:
Univ Valencia, Gen Hosp, Valencia, Spain
Bonet, L:
Hosp Son Espases, Palma De Mallorca, Spain
Gallego, A:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Garcia-Samaniego, J:
Hosp Carlos III, CIBERehd, Madrid, Spain
Testillano, M:
Hosp Cruces, Bizkaia, Spain
Rodriguez, M:
Univ Oviedo, Hosp Cent Asturias, E-33080 Oviedo, Spain
Castellano, G:
Hosp Univ 12 Octubre, Madrid, Spain
Gutierrez, ML:
Hosp Univ Fdn Alcorcon, Alcorcon, Spain
Delgado, M:
Hosp Univ La Coruna, La Coruna, Spain
Mas, A:
Hosp Clin Barcelona, Barcelona, Spain
Romero-Gomez, M:
Hosp Univ Valme, CIBERehd, Seville, Spain
Calleja, JL:
Hosp Puerta Hierro, Madrid, Spain
Gonzalez-Guirado, A:
Fdn Jimenez Diaz, Madrid, Spain
Arenas, JI:
Hosp Univ Donostia, Donostia San Sebastian, Spain
Garcia-Buey, L:
Hosp Univ La Princesa, CIBERehd, Madrid, Spain
Andrade, R:
Hosp Virgen de la Victoria, CIBERehd, Malaga, Spain
Gila, A:
Hosp Univ San Cecilio, Granada, Spain
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