REAL-B (Real-world Effectiveness from the Asia Pacific Rim Liver Consortium for HBV) - A Risk Score for the Prediction of Hepatocellular Carcinoma (HCC) in Chronic Hepatitis (CHB) Patients Treated with Oral Anti-HBV Therapy

Abstract

Background: The PAGE‐B score was developed to predict HCC risk in treated Caucasian CHB patients. This study developed, validated and compared a non‐invasive risk score (REAL‐B score) to predict HCC in a large consortium of Asian Americans and Asia Asians with CHB on oral antiviral therapy. Methods: Data were from the REAL‐B consortium database (n=9106 treated CHB patients; 6 US and 11 centers from 5 Asia Pacific countries). Patients excluded (n=1752) had HCC at baseline, within 1 year from study entry or treatment date before study For risk score development, patients were randomly divided into 2 groups: derivation group [(DG), n=4902; 368 HCC cases] and validation group [(VG) n=2452; 173 HCC cases]. Cox regression analyses determined HCC predictors. Results: Overall, median age 49.0 (39.2‐57.0) years; majority male (70%), no cirrhosis (82%) or decompensated cirrhosis (92%) at baseline, HBeAg negative (65%), HBV genotype B (59%), CPT class A (82%), median MELD score 6.3 (6.0‐7.4) There were no significant differences in demographics between DG/VG groups. In the DG, cirrhosis at baseline (HR: 2.59, 95% CI: 2.00‐3.36, p<0.0001; score=2) and platelet count < 100 (HR: 2.24, 95% CI 1. 54‐3.25, p<0.001; score=2) were strongest HCC predictors followed by age, male gender, diabetes mellitus, lower platelet count and AFP >20; variables formed a 13‐point REAL‐B score to predict 10‐year HCC risk range 0.004 to 0.83. In VG cohort, PAGE‐B score produced an area under the curve (AUROC) of 0.74‐0.73 predicting HCC risk at 3, 5, 10 years respectively. The REAL‐B score performed significantly better than PAGE‐B predicting risk of 3, 5, 10‐year HCC development with AUROC of 0.800.77 (p=0.0111‐0.0013), respectively (Figure). Using the REAL‐B score, the projected cumulative incidence of HCC at the 10th year in VG was 4.1%, 17.4%, and 63.6% for low, medium, and high score groups, respectively Conclusion: The REAL‐B score is an updated model based on five physiologic variables and the presence of diabetes mellitus and has a high 10‐year predictability for HCC development in Asian CHB patients on treatment.