Abstract
Simple SummaryWe developed a novel risk-scoring model for hepatocellular carcinoma development in treatment-naïve patients with chronic hepatitis B virus infection who are starting antiviral therapy with entecavir or tenofovir. The model reflects age, platelet count, hepatitis B e antigen positivity, serum albumin and total bilirubin levels, cirrhosis development, and liver stiffness values measured by transient elastography. Our new model showed better performance for predicting hepatocellular carcinoma development (Harrell’s c-index: 0.799) than the PAGE-B, modified PAGE-B, and modified REACH-B models in Asian patients with chronic hepatitis B receiving potent antiviral therapy.Hepatocellular carcinoma (HCC) risk prediction is important to developing individualized surveillance approaches. We designed a novel HCC prediction model using liver stiffness on transient elastography for patients receiving antiviral therapy against hepatitis B virus (HBV) infection. We recruited 2037 patients receiving entecavir or tenofovir as first-line antivirals and used the Cox regression analysis to determine key variables for model construction. Within 58.1 months (median), HCC developed in 182 (8.9%) patients. Patients with HCC showed a higher prevalence of cirrhosis (90.7% vs. 45.9%) and higher liver stiffness values (median 13.9 vs. 7.2 kPa) than those without. A novel nomogram (score 0–304) was established using age, platelet count, cirrhosis development, and liver stiffness values, which were independently associated with increased HCC risk, along with hepatitis B e antigen positivity and serum albumin and total bilirubin levels. Cumulative HCC probabilities were 0.7%, 5.0%, and 22.7% in the low- (score ≤87), intermediate- (88–222), and high-risk (≥223) groups, respectively. The c-index value was 0.799 (internal validity: 0.805), higher than that of the PAGE-B (0.726), modified PAGE-B (0.756), and modified REACH-B (0.761) models (all p < 0.05). Our nomogram showed acceptable performance in predicting HCC in Asian HBV-infected patients receiving potent antiviral therapy.
Highlights
Approximately 240 million individuals are chronically infected with hepatitis B virus (HBV), which remains a major etiology of hepatocellular carcinoma (HCC) and cirrhosis, especially in endemic areas, including the Republic of Korea [1,2,3]
Given that the risk of HCC can be substantially modified by antiviral therapy (AVT), several models designed for patients receiving nucleos(t)ide analogs, including modified REACH-B, PAGE-B, and modified PAGE-B, were developed with remarkable performance [16,17,18]
In the current era of potent AVT, we aimed to establish a novel prediction model for HCC development optimized for patients with chronic hepatitis B (CHB) receiving ETV and tenofovir disoproxil fumarate (TDF) based on liver stiffness on transient elastography, one of the most reliable fibrosis markers, and validate its role in comparison with that of other prediction models
Summary
Approximately 240 million individuals are chronically infected with hepatitis B virus (HBV), which remains a major etiology of hepatocellular carcinoma (HCC) and cirrhosis, especially in endemic areas, including the Republic of Korea [1,2,3]. Several efforts were made to evaluate HCC development in patients with CHB Several models, such as the GAG-HCC, CU-HCC, and REACH-B, were designed with sufficiently good prognostic performance [13,14,15]. Their predictive powers were validated in Asian patients with CHB, they were designed primarily for patients with CHB who were not receiving nucleos(t)ide analogs. Given that the risk of HCC can be substantially modified by AVT, several models designed for patients receiving nucleos(t)ide analogs, including modified REACH-B (mREACH-B), PAGE-B, and modified PAGE-B (mPAGE-B), were developed with remarkable performance [16,17,18]. The introduction of noninvasive fibrosis tests, such as transient elastography, could further refine the prediction of HCC risk
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