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

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.