T-15 Interim analysis of the Italian Master-Entas cohort study: entecavir can improve liver function in patients with chronic hepatitis B and liver cirrhosis

Abstract

ance and side effects. Median age was 55 years (24–83) and median time to the first visit was 3.5 months. Forty-four per cent had liver cirrhosis. Seventeen patients were NUC experienced (8 LAM, 5 ADV+LAM, 1 LdT+LAM, 2 ADV, 1 TNF), 1/17 NUC experienced patients started a combination treatment with TDF-ETV. Cumulative rates of undetectable hepatitis B virus DNA were 62.8%, 83.1%, 89% and 89% and normalization of ALT was 59.2%, 78.7%, 87.1% and 81.2% at 6, 12, 18 and 24 months of follow-up. Thirty-nine patients were HBeAg positive and 17 achieved negative HBeAg with anti-HBe seroconversion in 15 cases (38.4%). HBsAg loss was observed in 5 patients. Two patients switched to TDF, in one case because of virologic failure and in the second one because of partial virologic response. Drug resistance mutations were evaluated in 10 patients at the first visit showing in a LAM-ADV experienced, patient mutation A181T and in the second LAM experienced patient, mutation A181V. During follow-up, drug resistance mutations were assessed in 15 patients, identifying A181V-T184S in a subject (LAM-ADV experienced) and L180M-M250V-M204V in the patient presenting virological failure (LAM experienced). Treatment compliance was in 96.3% of the patients, in 9/11 not compliant subjects undetectable HBV-DNA was achieved. The study of Entecavir treatment in field practice confirms its efficacy in suppressing HBV replication with rare drug resistance mutations and its safety in patients with chronic hepatitis and liver cirrhosis.