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Abstract Details
Lower Observed Hepatocellular Carcinoma Incidence in Chronic Hepatitis B Patients Treated With Entecavir: Results of the ENUMERATE Study
Ahn J1, Lim JK2, Lee HM3, Lok AS4, Nguyen M5, Pan CQ6, Mannalithara A5, Te H7, Reddy KR8, Trinh H9, Chu D10, Tran T11, Lau D12, Leduc TS13, Min A14, Trong Le L15, Bae H16, Van Tran S17, Do S18, Hann HL19, Wong C20, Han S21, Pillai A22, Park JS23, Tong M22, Scaglione S24, Woog J25, Kim WR5. Am J Gastroenterol. 2016 Jun 21. doi: 10.1038/ajg.2016.257. [Epub ahead of print]
Author information
1Division of Gastroenterology and Hepatology, Oregon Health and Science University, Portland, Oregon, USA.
2Department of Digestive Diseases, Yale University, New Haven, Connecticut, USA.
3Gastroenterology/Hepatology Division, Virginia Commonwealth University, Richmond, Virginia, USA.
4Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA.
5Division of Gastroenterology and Hepatology, Stanford University, Stanford, California, USA.
6Department of Medicine, NYU Langone, New York City, New York, USA.
7Digestive Disease Center, University of Chicago, Chicago, Illinois, USA.
8Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
9San Jose GI, San Jose, California, USA.
10NYU School of Medicine, New York City, New York, USA.
11Department of Medicine, Cedars Sinai Medical Center, Los Angeles, California, USA.
12Department of Gastroenterology and Hepatology, BIDMC, Boston, Massachusetts, USA.
13Leduc Medical Group, Fountain Valley, California, USA.
14Division of Gastroenterology, Mount Sinai Beth Israel, New York City, New York, USA.
15Woodholme Gastroenterology Associates, Pikeville, Maryland, USA.
16Asian Pacific Liver Center, Los Angeles, California, USA.
17Falls Church Family Practice, Falls Church, Virginia, USA.
18Digestive Health Associates of Texas, Plano, Texas, USA.
19Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
20San Francisco, California, USA.
21University of California, Los Angeles, Los Angeles, California, USA.
22Emory University, Atlanta, Georgia, USA.
23NYU Langone, New York City, New York, USA.
24Loyola University, Maywood, Illinois, USA.
25Asian Health Foundation, Philadelphia, Pennsylvania, USA.
Abstract
OBJECTIVES:
Data from the United States are lacking regarding the impact of entecavir (ETV) on the risk of hepatocellular carcinoma (HCC). Our aim is to determine whether treatment with ETV is associated with a reduced HCC risk by calculating the expected HCC incidence based on the Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B (REACH-B) model and comparing it with the observed HCC incidence.
METHODS:
The incidence of HCC in US patients treated with ETV between 2005 and 2013 in a retrospective cohort was obtained. The predicted HCC incidence was calculated using the REACH-B model. The standardized incidence ratios (SIRs) were calculated as a ratio of observed over predicted HCC cases.
RESULTS:
Of 841 patients, 646 (65% male, 84% Asian, median age 47 years, 36% hepatitis B e antigen positive, 9.4% with cirrhosis) met the inclusion criteria. Over a median follow-up of 4 years, 17 (2.6%) cases of HCC were diagnosed, including 8 out of 61 (13.1%) patients with cirrhosis and 9 out of 585 (1.5%) without cirrhosis. Compared with those without HCC, the 17 patients with HCC were older at 53 years vs. 47 years and more likely to have cirrhosis at 47.1% vs. 8.4%. Among patients without cirrhosis, the observed HCC incidence was significantly lower than predicted by the fourth year (SIR, 0.37; 95% confidence interval: 0.166-0.82). A sensitivity analysis that comprised all patients, including those with cirrhosis, showed that at the maximum follow-up time of 8.2 years, a significantly lower than predicted HCC incidence was noted with an SIR of 0.56 (95% confidence interval: 0.35-0.905).
CONCLUSIONS:
Based on the REACH-B model, long-term ETV therapy was associated with a lower than predicted HCC incidence. However, the risk of HCC persisted, and careful HCC surveillance remains warranted despite the anti-viral treatment.