Risk-based hepatocellular carcinoma surveillance thresholds using a prediction score in Asian patients with chronic hepatitis B: a nationwide cohort study.

Abstract

Backgrounds/Aims This study aimed to quantify hepatocellular carcinoma (HCC) incidence according to a validated prediction score and to define score-based cut-offs corresponding to surveillance-relevant incidence thresholds in Asian patients with chronic hepatitis B (CHB) receiving antiviral therapy. Methods We conducted a nationwide population-based cohort study using the Korean National Health Insurance Service database. Adults with CHB initiating nucleos(t)ide analogue therapy between 2012 and 2023 were included, hose with viral coinfections, prior malignancy, or decompensated cirrhosis were excluded. HCC risk was stratified using the HCC-RESCUE score. Incident HCC was the primary outcome. Annual HCC incidence rates and adjusted hazard ratios were estimated using multivariable Cox proportional hazards models. Results Among 199,143 treated patients (median follow-up, 7.3 years), 15,233 developed HCC. Adjusted annual HCC incidence increased progressively across risk strata: 0.31% (95% CI 0.24-0.40) in the low-risk group, 1.09% (0.84-1.41) in the intermediate-risk group, and 1.85% (1.44-2.40) in the high-risk group. Compared with the low-risk group, adjusted hazard ratios for HCC were 3.48 (95% CI 3.35-3.61) and 5.90 (5.62-6.19) in the intermediate- and high-risk groups, respectively (all p<0.001). HCC-RESCUE scores corresponding to annual HCC incidence thresholds of 0.2%, 1.5%, and 3.0% were 47, 66, and 90. Conclusions In a large antiviral-treated Asian CHB population, prediction score-based stratification revealed a graded spectrum of residual HCC risk and identified incidence-aligned thresholds relevant to surveillance. These findings support incidence-informed refinement of HCC surveillance strategies that complement traditional cirrhosis-based criteria in the antiviral treatment era.