Clinical and virologic response to entecavir in HBV related chronic hepatitis or cirrhosis: data from the clinical practice in a single centre cohort.

Background. Limited data are available on entecavir in Caucasian patients with hepatitis B virus cirrhosis or chronic hepatitis B, treated in the clinical practice. The aim was to evaluate the efficacy of entecavir in an Italian cohort of unselected patients with different stages of liver fibrosis, comparing the virological and clinical results obtained between patients with and without liver cirrhosis. Methods. Efficacy and safety of entecavir were retrospectively evaluated in 100 patients recruited in our Gastro-Hepatology Unit. A pharmacokinetic study was performed in 34 of them to assess whether cirrhosis may affect entecavir metabolism. They were followed-up for a median time of 21 months (2-108). Results. The rate of virologic response (negative viremia by PCR for at least two consecutive determinations) after 12, 24 and 36 months were 91.7%, 97.5% and 93.7%, respectively. In the 84 patients who were treated for at least 12 months, presence of cirrhosis (O.R. 1.730, 95% C.I. 1.082-2.766, p= 0.022) and absence of HBeAg (O.R. 0.479, 95% C.I. 0.273-0.842, p= 0.011) were independent predictors of earlier clearance of serum HBV DNA. There were no differences between the serum concentrations in the steady state level of entecavir between patients with or without cirrhosis. No significant differences were detected between the average area under the curve in the means of the two groups (p= 0.55). Conclusions. Entecavir represents an excellent therapy in patients with HBV-related liver disease and particularly with cirrhosis where it showed a good profile of tolerability, higher efficacy and an earlier virological response.