Entecavir safety and effectiveness in a national cohort of treatment-naive chronic hepatitis B patients in the US - the ENUMERATE study.

ABSTRACT:

Background

Entecavir (ETV) has been shown to be safe and efficacious in randomised controlled trials in highly selected patients with hepatitis B virus (HBV) infection.

Aim

To determine the safety and effectiveness of ETV in 'real-world' HBV patients in the United States (US).

Methods

Treatment-naïve HBV patients ≥18 years old who received ETV for ≥12 months between 2005 and 2013 were included in a retrospective, cohort study. Rates of ALT normalisation, undetectable HBV DNA, HBeAg and HBsAg loss/seroconversion, adverse events (AE) and clinical outcomes were evaluated.

Results

Of 841 patients, 658 [65% male, 83% Asian; median age 47 years] met the inclusion criteria. 36% were HBeAg+ and 9.3% cirrhotic. 89% had abnormal ALT. Baseline median HBV DNA was 5.8 log 1

SUBMITTER: Ahn J 

PROVIDER: S-EPMC4926997 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature