Received 29 September 2011; received in revised form 12 April 2012; accepted 18 April 2012. published online 01 June 2012.
Background & Aims
We determined the antiviral potency and viral resistance rate after 4years of continuous entecavir treatment in patients with chronic hepatitis B (CHB) infection.
Methods
The cumulative rates of undetectable hepatitis B virus DNA (HBV DNA;<2.6 log10 copies/ml), hepatitis B e antigen (HBeAg) seronegativity, seroconversion, alanine aminotransferase (ALT) normalization, and entecavir signature mutations were calculated in 474 nucleos(t)ide-naïve CHB patients (HBeAg-positive: 47%) on continuous entecavir treatment for 4years.
Results
Median age was 47years and follow-up period was 2.4years, with 403, 281, 165, and 73 patients followed-up for at least 1, 2, 3, and 4years, respectively. Incremental increases were observed in the rates of undetectable HBV DNA, HBeAg seroclearance and seroconversion, and ALT normalization, reaching 96%, 42%, 38% and 93%, respectively, by the fourth year. In all, 100% and 93% of patients negative and positive for HBeAg, respectively, had undetectable HBV DNA at year 4. Of 165 patients, HBV DNA was detectable in nine patients after 3years. Multivariate analysis identified HBV DNA level (⩽7.6log10 copies/ml, OR=15.8; 95% CI=43.1–79.9, P=0.001) as an independent predictor of undetectable HBV DNA at year 3. Five patients experienced virological breakthrough including two (0.4%) who developed entecavir-resistance mutations.
Conclusions
Continuous treatment of nucleos(t)ide-naïve CHB patients with entecavir over 4years was associated with 96% chance of undetectable HBV DNA and only 0.4% chance of emerging entecavir-resistant mutations. 作者: StephenW 时间: 2012-8-16 21:26