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

Joseph Ahn, H. M. Lee, J. K. Lim, C. Q. Pan, M. H. Nguyen, W. Ray Kim, A. Mannalithara, H. Trinh, D. Chu, T. Tran, A. Min, S. Do, H. Te, K. R. Reddy, A. S. Lok

Research output: Contribution to journalArticle

27 Citations (Scopus)

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 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.

Original languageEnglish (US)
Pages (from-to)134-144
Number of pages11
JournalAlimentary Pharmacology and Therapeutics
Volume43
Issue number1
DOIs
StatePublished - Jan 1 2016

Fingerprint

Chronic Hepatitis B
Hepatitis B e Antigens
Hepatitis B virus
Safety
Therapeutics
DNA
Hepatitis B Surface Antigens
entecavir
Virus Diseases
Liver Neoplasms
Cohort Studies
Randomized Controlled Trials
Retrospective Studies
Clinical Trials
Liver

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

Entecavir safety and effectiveness in a national cohort of treatment-naïve chronic hepatitis B patients in the US - The ENUMERATE study. / Ahn, Joseph; Lee, H. M.; Lim, J. K.; Pan, C. Q.; Nguyen, M. H.; Ray Kim, W.; Mannalithara, A.; Trinh, H.; Chu, D.; Tran, T.; Min, A.; Do, S.; Te, H.; Reddy, K. R.; Lok, A. S.

In: Alimentary Pharmacology and Therapeutics, Vol. 43, No. 1, 01.01.2016, p. 134-144.

Research output: Contribution to journalArticle

Ahn, J, Lee, HM, Lim, JK, Pan, CQ, Nguyen, MH, Ray Kim, W, Mannalithara, A, Trinh, H, Chu, D, Tran, T, Min, A, Do, S, Te, H, Reddy, KR & Lok, AS 2016, 'Entecavir safety and effectiveness in a national cohort of treatment-naïve chronic hepatitis B patients in the US - The ENUMERATE study', Alimentary Pharmacology and Therapeutics, vol. 43, no. 1, pp. 134-144. https://doi.org/10.1111/apt.13440
Ahn, Joseph ; Lee, H. M. ; Lim, J. K. ; Pan, C. Q. ; Nguyen, M. H. ; Ray Kim, W. ; Mannalithara, A. ; Trinh, H. ; Chu, D. ; Tran, T. ; Min, A. ; Do, S. ; Te, H. ; Reddy, K. R. ; Lok, A. S. / Entecavir safety and effectiveness in a national cohort of treatment-naïve chronic hepatitis B patients in the US - The ENUMERATE study. In: Alimentary Pharmacology and Therapeutics. 2016 ; Vol. 43, No. 1. pp. 134-144.
@article{801f28509d3c47e388e431fd6abd1f8f,
title = "Entecavir safety and effectiveness in a national cohort of treatment-na{\"i}ve 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-na{\"i}ve 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.",
author = "Joseph Ahn and Lee, {H. M.} and Lim, {J. K.} and Pan, {C. Q.} and Nguyen, {M. H.} and {Ray Kim}, W. and A. Mannalithara and H. Trinh and D. Chu and T. Tran and A. Min and S. Do and H. Te and Reddy, {K. R.} and Lok, {A. S.}",
year = "2016",
month = "1",
day = "1",
doi = "10.1111/apt.13440",
language = "English (US)",
volume = "43",
pages = "134--144",
journal = "Alimentary Pharmacology and Therapeutics",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "1",

}

TY - JOUR

T1 - Entecavir safety and effectiveness in a national cohort of treatment-naïve chronic hepatitis B patients in the US - The ENUMERATE study

AU - Ahn, Joseph

AU - Lee, H. M.

AU - Lim, J. K.

AU - Pan, C. Q.

AU - Nguyen, M. H.

AU - Ray Kim, W.

AU - Mannalithara, A.

AU - Trinh, H.

AU - Chu, D.

AU - Tran, T.

AU - Min, A.

AU - Do, S.

AU - Te, H.

AU - Reddy, K. R.

AU - Lok, A. S.

PY - 2016/1/1

Y1 - 2016/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84983189758&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84983189758&partnerID=8YFLogxK

U2 - 10.1111/apt.13440

DO - 10.1111/apt.13440

M3 - Article

C2 - 26510638

AN - SCOPUS:84983189758

VL - 43

SP - 134

EP - 144

JO - Alimentary Pharmacology and Therapeutics

JF - Alimentary Pharmacology and Therapeutics

SN - 0269-2813

IS - 1

ER -