ORIGINAL ARTICLE   

Minerva Gastroenterologica e Dietologica 2018 September;64(3):201-7

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

BACKGROUND: Therapy in chronic hepatitis B (chronic hepatitis B) 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 - Hepatitis B, chronic - Entecavir