Lower Observed Hepatocellular Carcinoma Incidence in Chronic Hepatitis B Patients Treated With Entecavir: Results of the ENUMERATE Study - PubMed (original) (raw)

Observational Study

. 2016 Sep;111(9):1297-304.

doi: 10.1038/ajg.2016.257. Epub 2016 Jun 21.

Joseph K Lim 2, Hannah M Lee 3, Anna S Lok 4, Mindie Nguyen 5, Calvin Q Pan 6, Ajitha Mannalithara 5, Helen Te 7, K Rajender Reddy 8, Huy Trinh 9, Danny Chu 10, Tram Tran 11, Daryl Lau 12, Truong-Sinh Leduc 13, Albert Min 14, Loc Trong Le 15, Ho Bae 16, Sang Van Tran 17, Son Do 18, Hie-Won L Hann 19, Clifford Wong 20, Steven Han 21, Anjana Pillai 22, James S Park 23, Myron Tong 22, Steve Scaglione 24, Jocelyn Woog 25, W Ray Kim 5

Affiliations

Observational Study

Lower Observed Hepatocellular Carcinoma Incidence in Chronic Hepatitis B Patients Treated With Entecavir: Results of the ENUMERATE Study

Joseph Ahn et al. Am J Gastroenterol. 2016 Sep.

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.

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