Continuous entecavir for treatment naïve chinese chronic hepatitis B patients in the real world setting the seven year results

Abstract

BACKGROUND: There is paucity of data on uninterrupted entecavir for treatment-naïve chronic hepatitis B (CHB) beyond 6 years. METHODS: Treatment–naïve Chinese CHB patients were treated continuously with entecavir for up to 7 years. The cumulative rates of HBV DNA undetectability, alanine aminotransferase (ALT) normalization, hepatitis B e-antigen (HBeAg) seroconversion, virological breakthrough, hepatitis B surface antigen (HBsAg) reduction and genotypic resistance to entecavir were determined. HBV DNA levels were measured by Roche Taqman real time PCR assay. Resistance profile was determined by line probe assay (LiPA, Innogenetics NV, Gent, Belgium). Serum HBsAg levels were performed using Elecsys HBsAg II assay (Roche Diagnostics, Gmbh, Mannheim). RESULTS: 222 Chinese CHB patients (median age 45 years, 70.7 % male) were recruited. 222, 188, 173, 170, 167,162 and 160 patients were followed up for 1, 2, 3, 4, 5, 6 and 7 years respectively. The cumulative rate of HBV DNA undetectability, ALT normalization, HBeAg seroconversion (90 patients were HBeAg positive at baseline) were 98.7, 98.3, 90.2 % up to year 7 respectively. The cumulative rate of virologic breakthrough was 8.3 %. Entecavir signature mutations were found in 2 patients. The cumulative rate of entecavir resistance up to 7 years was 1.2 %. The median rate of HBsAg reduction over 6 years of treatment was 0.095 log IU/ml/year. 15.2 and 7.9 % patients had HBsAg levels less than 200 and 100 IU/mL at the last follow-up. 2 patients developed HBsAg seroconversion at year 2 and 6 respectively. There were no serious adverse events reported. CONCLUSION: Prolonged,uninterrupted entecavir therapy is an effective and safe treatment for CHB patients.