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A Comparison Between Community and Academic Practices in the USA in the Management of Chronic Hepatitis B Patients Receiving Entecavir: Results of the ENUMERATE Study

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Abstract

Background and Aims

The management of chronic hepatitis B patients is not well characterized in real-world practice. We compared baseline characteristics of CHB patients on entecavir, the frequency of on-treatment monitoring, and the effectiveness of ETV treatment between academic and community practices.

Methods

Treatment-naïve CHB patients ≥18 years old, treated with ETV for ≥12 months from 2005 to 2013, in 26 community and academic practices throughout the USA were retrospectively evaluated.

Results

Of 841 patients enrolled, 658 (65% male, 83% Asian, median age 47, 9% with cirrhosis) met inclusion criteria. Half of the patients (52%) were from community practices. A lower percentage of patients in community practices had cirrhosis or liver cancer (5 vs. 14%). Community practices more often treated patients with baseline ALT < 2 × ULN. Over a median follow-up of 4 years, community practices were more likely to discontinue ETV with less frequent laboratory monitoring compared to academic practices. The 5-year cumulative probability of ALT normalization was greater among patients treated in community practices (70 vs. 50%, p < 0.001), but the 5-year cumulative probability of undetectable HBV DNA was lower (45 vs. 70%, p < 0.001) than those treated in academic practices.

Conclusion

Academic practices saw CHB patients with more advanced liver disease, more often followed AASLD guidelines, and monitored patients on ETV treatment more frequently than community practices. While patients in community practices were less likely to achieve undetectable HBV DNA and more likely to achieve ALT normalization, the rates of HBeAg loss and seroconversion as well as HBsAg loss were similar.

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Abbreviations

ALT:

Alanine aminotransferase

CHB:

Chronic hepatitis

ETV:

Entecavir

TDF:

Tenofovir disoproxil fumarate

HBeAg:

Hepatitis B e antigen

anti-HBe:

Hepatitis B e antibody

HBV:

Hepatitis B virus

IRB:

Institutional review board

KM:

Kaplan–Meier

US:

USA

NAFLD:

Nonalcoholic fatty liver disease

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Acknowledgments

The authors thank the following ENUMERATE investigators and AHF members for their contributions: Daryl Lau: Beth Israel Deaconess Medical Center; Truong-Sinh Leduc: Leduc Medical Group; Albert Min: Mount Sinai Beth Israel, NYC, NY; Loc Trong Le: Woodholme Gastroenterology Associates; Ho Bae: Asian Pacific Liver Center; San Van Tran: Sang Van Tran PC; Son Do: Digestive Health Associates of Texas, Plano, TX; Hie-Won L. Hann: Jefferson University Hospitals; Clifford Wong: San Francisco, CA; Steve-Huy Han: UCLA; K. Rajender Reddy: University of Pennsylvania, Philadelphia, PA; James Park: New York University; Anjana Pillai: Emory University; Myron Tong: UCLA.

Author’s contribution

Hannah Lee, Joseph Ahn, Joseph Lim, W. Ray Kim, Calvin Pan, Mindie Nguyen, and Anna Lok helped in study concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, critical revision of the manuscript for important intellectual content, obtained funding, and study supervision. Donghee Kim and Ajitha Mannalithara contributed to statistical analysis. Huy Trinh, Danny Chu, Tram Tran, Helen Te, and Jocelyn Woog helped in acquisition of data, critical revision of the manuscript for important intellectual content.

Funding

This study is supported by an investigator-initiated grant to the Asian Health Foundation by Bristol-Myers Squibb.

Author information

Authors and Affiliations

  1. Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University Medical Center, 1200 E. Broad St., 14th Floor, P.O. Box 980341, Richmond, VA, 23298, USA

    Hannah M. Lee

  2. Division of Gastroenterology and Hepatology, Oregon Health and Science University, Portland, OR, USA

    Joseph Ahn

  3. Division of Gastroenterology and Hepatology, Stanford University, Stanford, CA, USA

    W. Ray Kim, Mindie Nguyen, Donghee Kim & Ajitha Mannalithara

  4. Yale University, New Haven, CT, USA

    Joseph K. Lim

  5. Division of Gastroenterology and Hepatology, NYU Langone Health, NYU School of Medicine, New York, USA

    Calvin Q. Pan

  6. Digestive Disease Center, University of Chicago, Chicago, IL, USA

    Helen Te

  7. San Jose Gastroenterology, San Jose, CA, USA

    Huy Trinh

  8. Albert Einstein College of Medicine, New York, NY, USA

    Danny Chu

  9. Department of Medicine, Cedars Sinai Medical Center, Los Angeles, CA, USA

    Tram Tran

  10. Asian Health Foundation, Rochester, MN, USA

    Jocelyn Woog

  11. Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI, USA

    Anna S. Lok

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  1. Hannah M. Lee
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Corresponding author

Correspondence to Hannah M. Lee.

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Conflict of interest

Hannah Lee and Joseph Ahn have no disclosures. Anna S. Lok has research grant support from Bristol-Myers Squibb, Gilead Sciences and NIH Grant U01 DK082863. Mindie Nguyen has research support from BMS, Gilead, Janssen, National Cancer Institute, Pfizer. She is on the Advisory board/consultant for Janssen, Novartis, Gilead, Alnylam, Dynavax, Spring Bank, Intercept. Calvin Pan is a speaker, consultant for Bristol-Myers Squibb. Helen Te has research grant support from Abbvie, Conatus, Bristol-Myers Squibb. She is on the Advisory board for Bristol-Myers Squibb. Danny Chu is on the Advisory board and speaker’s bureau for Gilead Sciences. Tram Tran has Research grant support from Bristol-Myers Squibb and Gilead Sciences. She is on the Advisory board for Bristol-Myers Squibb and Gilead Sciences. There is no other disclosures for all other authors.

Ethical statement

Hannah Lee confirms that this work is original and has not been published elsewhere nor is it currently under consideration for publication elsewhere. Hannah Lee is acting as the submission’s guarantor and takes responsibility for the integrity of the work as a whole, from inception to published article. All authors approved the final version of the article.

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Lee, H.M., Ahn, J., Kim, W.R. et al. A Comparison Between Community and Academic Practices in the USA in the Management of Chronic Hepatitis B Patients Receiving Entecavir: Results of the ENUMERATE Study. Dig Dis Sci 64, 358–366 (2019). https://doi.org/10.1007/s10620-018-5281-3

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