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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.

AbstractBACKGROUND:
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.
AuthorsJ 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
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 43 Issue 1 Pg. 134-44 (Jan 2016) ISSN: 1365-2036 [Electronic] England
PMID26510638 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Copyright© 2015 John Wiley & Sons Ltd.
Chemical References
  • Antiviral Agents
  • Hepatitis B Surface Antigens
  • Hepatitis B e Antigens
  • entecavir
  • Guanine
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antiviral Agents (administration & dosage, adverse effects, therapeutic use)
  • Female
  • Guanine (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
  • Hepatitis B Surface Antigens (immunology)
  • Hepatitis B e Antigens (immunology)
  • Hepatitis B virus (genetics)
  • Hepatitis B, Chronic (drug therapy)
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Young Adult

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