Real-world effectiveness from the asia pacific rim liver consortium for hbv risk score for the prediction of hepatocellular carcinoma in chronic hepatitis b patients treated with oral antiviral therapy
Journal
Journal of Infectious Diseases
Journal Volume
221
Journal Issue
3
Pages
389-399
Date Issued
2020
Author(s)
Yang H.-I.
Yeh M.-L.
Wong G.L.
Peng C.-Y.
Chen C.-H.
Trinh H.N.
Cheung K.-S.
Xie Q.
Kozuka R.
Lee D.-H.
Ogawa E.
Zhao C.
Ning H.-B.
Huang R.
Li J.
Zhang J.Q.
Ide T.
Xing H.
Iwane S.
Takahashi H.
Wong C.
Wong C.
Lin C.-H.
Hoang J.
Le A.
Henry L.
Toyoda H.
Ueno Y.
Gane E.J.
Eguchi Y.
Kurosaki M.
Wu C.
Liu C.
Shang J.
Furusyo N.
Enomoto M.
Yuen M.-F.
Yu M.-L.
Nguyen M.H.
Abstract
Background. Patients on oral antiviral (OAV) therapy remain at hepatocellular carcinoma (HCC) risk. Risk prediction tools distinguishing treated patients with residual HCC risk are limited. The aim of this study was to develop an accurate, precise, simple-to-use HCC risk score using routine clinical variables among a treated Asian cohort. Methods. Adult Asian chronic hepatitis B (CHB) patients on OAV were recruited from 25 centers in the United States and the Asia-Pacific region. Excluded persons were coinfected with hepatitis C, D, or human immunodeficiency virus, had HCC before or within 1 year of study entry, or their follow-up was <1 year. Patients were randomized to derivation and validation cohorts on a 2:1 ratio. Statistically significant predictors from multivariate modeling formed the Real-world Effectiveness from the Asia Pacific Rim Liver Consortium for HBV (REAL-B) score. Results. A total of 8048 patients were randomized to the derivation (n = 5365) or validation group (n = 2683). The REAL-B model included 7 variables (male gender, age, alcohol use, diabetes, baseline cirrhosis, platelet count, and alpha fetoprotein), and scores were categorized as follows: 0-3 low risk, 4-7 moderate risk, and 8-13 high risk. Area under receiver operating characteristics were >0.80 for HCC risk at 3, 5, and 10 years, and these were significantly higher than other risk models (p <.001). Conclusions. The REAL-B score provides 3 distinct risk categories for HCC development in Asian CHB patients on OAV guiding HCC surveillance strategy. ? The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. DOI: 10.1093/infdis/jiz477
Subjects
Asian; Liver cancer; Treatment; Viral hepatitis; Viral suppression
SDGs
Other Subjects
alpha fetoprotein; antivirus agent; entecavir; lamivudine; peginterferon; telbivudine; tenofovir disoproxil; antivirus agent; virus DNA; adult; age distribution; alcohol consumption; Article; cancer risk; China; chronic hepatitis B; controlled study; diabetes mellitus; disease surveillance; female; follow up; Hepatitis B Virus Risk Score; high risk patient; Hong Kong; human; human cell; intermediate risk patient; Japan; liver cell carcinoma; liver cirrhosis; low risk patient; major clinical study; male; measurement accuracy; measurement precision; New Zealand; platelet count; randomized controlled trial; risk assessment; sex difference; South Korea; Taiwan; United States; validation study; Asia; Asian continental ancestry group; chronic hepatitis B; cohort analysis; ethnology; genetics; Hepatitis B virus; liver cell carcinoma; liver tumor; methodology; middle aged; oral drug administration; proportional hazards model; randomization; receiver operating characteristic; risk assessment; virology; Administration, Oral; Adult; Antiviral Agents; Asia; Asian Continental Ancestry Group; Carcinoma, Hepatocellular; Cohort Studies; Data Accuracy; DNA, Viral; Female; Hepatitis B virus; Hepatitis B, Chronic; Humans; Liver Neoplasms; Male; Middle Aged; Proportional Hazards Models; Random Allocation; Research Design; Risk Assessment; ROC Curve
Publisher
Oxford University Press
Type
journal article