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Entecavir safety and effectiveness in a national cohort of treatment-naïve chronic hepatitis B patients in the US – the ENUMERATE study
J. Ahn1,*, H. M. Lee2, J. K. Lim3, C. Q. Pan4, M. H. Nguyen5, W. Ray Kim5, A. Mannalithara5, H. Trinh6, D. Chu7, T. Tran8, A. Min9, S. Do10, H. Te11, K. R. Reddy12 andA. S. Lok13
Article first published online: 28 OCT 2015
DOI: 10.1111/apt.13440
© 2015 John Wiley & Sons Ltd
Issue
Cover image for Vol. 42 Issue 11-12
Alimentary Pharmacology & Therapeutics
Early View (Online Version of Record published before inclusion in an issue)
Author Information
1 Division of Gastroenterology & Hepatology, Oregon Health & Science University, Portland, OR, USA
2 Gastroenterology/Hepatology Division, Tufts Medical Center, Boston, MA, USA
3 Digestive Diseases, Yale University, New Haven, CT, USA
4 Department of Medicine, NYU Langone, New York, NY, USA
5 Division of Gastroenterology & Hepatology, Stanford University, Stanford, CA, USA
6 San Jose Gastroenterology, San Jose, CA, USA
7 Albert Einstein College of Medicine, New York, NY, USA
8 Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA, USA
9 Division of Gastroenterology, Mount Sinai Beth Israel, New York, NY, USA
10 Digestive Health Associates of Texas, Plano, TX, USA
11 Digestive Disease Center, University of Chicago, Chicago, IL, USA
12 Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA
13 Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA
* Correspondence to:
Dr Joseph Ahn, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, L-461, Portland, OR 97239, USA.
E-mail: [email protected]
This article was accepted for publication after full peer-review.
Summary
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 10 IU/mL. Median duration of ETV treatment was 4 years. Rates of ALT normalisation at 1, 3 and 5 years were 37.2%, 48.7% and 56.2% in HBeAg+ and 39.6%, 46.8% and 55.6% in HBeAg- patients. HBV DNA was undetectable at 1, 3 and 5 years in 34.6%, 64.7% and 84.6% in HBeAg+ patients, and 81.9%, 90.3% and 96.2% in HBeAg patients. Five-year cumulative probability of HBeAg loss and seroconversion was 46% and 33.7% and HBsAg loss was 4.6%. ETV was discontinued due to adverse events in 1.2% of patients. Hepatic decompensation occurred in 0.8%, liver cancer in 2.7% and death in 0.6%.
Conclusion
Entecavir treatment was safe in a large cohort of US patients, but ALT normalisation and hepatitis B virus DNA suppression rates were lower than previously reported in clinical trials.
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