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
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.
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.
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.
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.
KeywordsChronic HBV Practice management Antiviral therapy HBeAg loss HBsAg loss
Tenofovir disoproxil fumarate
Hepatitis B e antigen
Hepatitis B e antibody
Hepatitis B virus
Institutional review board
Nonalcoholic fatty liver disease
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.
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.
This study is supported by an investigator-initiated grant to the Asian Health Foundation by Bristol-Myers Squibb.
Compliance with ethical standards
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.
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.
- 3.Weinbaum M, Williams I, Mast E, et al. MMWR Recomm Rep. 2008;57 (RR-8):1–20.Google Scholar
- 4.Terrault NA, Lok AS, McMahon BJ, et al. Update on prevention, diagnosis, and treatment and of chronic hepatitis B: AASLD 2018 Hepatitis B Guidance. https://doi.org/10.1002/hep.29800.
- 10.Lok AS, McMahon BJ. Chronic Hepatitis B: Update 2009. Hepatology. 2009;50:1–36.Google Scholar