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MINERVA GASTROENTEROLOGICA E DIETOLOGICA

A Journal on Gastroenterology, Nutrition and Dietetics


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Minerva Gastroenterologica e Dietologica 2018 Jan 10

DOI: 10.23736/S1121-421X.18.02470-4

Copyright © 2018 EDIZIONI MINERVA MEDICA

language: English

Efficacy and safety of long term entecavir therapy in a European population

Alessandro COLLO 1, Paola BELCI 1, Sharmila FAGOONEE 2, Lucia LORETI 1, Valeria GARIGLIO 1, Ramona PARISE 1, Paola MAGISTRONI 1, Marilena DURAZZO 1

1 Department of Medical Sciences, University of Turin, Turin, Italy; 2 Institute for Biostructures and Bioimages (CNR) c/o Molecular Biotechnology Center, Turin, Italy


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BACKGROUND: Therapy in chronic hepatitis B (CHB) patients aims at improving their survival by preventing disease progression to cirrhosis and its complications. Entecavir (ETV) is currently a first line therapeutic agent recommended for the treatment of CHB. Our aim was to evaluate the long term outcome of a cohort of CHB patients treated with ETV.
METHODS: Thirty-four patients treated with ETV for at least 6 months were included in this study. The virologic response was determined by the dosage of serum HBV-DNA, HBsAg, HBeAg, anti-HBs and anti-HBe antibodies. Death, acute pancreatitis, lactic acidosis and kidney function impairment were considered as major adverse events.
RESULTS: The median period of treatment was 55 months (range 15-81). Thirty-three (97%) patients responded to the therapy after a mean time of 14.7 weeks (4-60); of these, 29 (85.3%) maintained the HBV-DNA negativity in serum, while 4 patients (11.8%) had a breakthrough. The remaining patient did not respond. Seroconversion to anti-HBs and anti-HBe was not observed, although 2 patients lost the e and the s antigen, respectively. Baseline alanine aminostransferase (ALT) levels in serum were altered in 18 patients (52.9%), and returned to normal levels during the follow-up, with a reduction of 87.7 IU/L (p <0,0001). A case (3.4%) of hepatocellular carcinoma was observed after 24 months. No major adverse events were recorded.
CONCLUSIONS: ETV is effective in suppressing viral replication as well as in normalizing serum ALT levels, without anti-HBs seroconversion. Finally, ETV is a safe drug, substantially free of major side effects.


KEY WORDS: Liver - Chronic hepatitis B - Entecavir

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Publication History

Article first published online: January 10, 2018
Manuscript accepted: January 4, 2018
Manuscript received: December 20, 2017

Cite this article as

Collo A, Belci P, Fagoonee S, Loreti L, Gariglio V, Parise R, et al. Efficacy and safety of long term entecavir therapy in a european population. Minerva Gastroenterol Dietol 2018 Jan 10. DOI: 10.23736/S1121-421X.18.02470-4

Corresponding author e-mail

marilena.durazzo@unito.it