Usefulness of the Fibrosis-4 index and alanine aminotransferase at 1 year of nucleos(t)ide analog treatment for prediction of hepatocellular carcinoma in chronic hepatitis B patients

Aim: Nucleos(t)ide analogs do not completely prevent hepatocellular carcinoma (HCC) in chronic hepatitis B virus infection. This study aimed to evaluate the dynamics of a non-invasive liver fibrosis marker, the Fibrosis-4 (FIB-4) index, for predicting HCC development. Methods: Among a total of 882 chronically hepatitis B virus infection-infected patients who were treated with nucleos(t)ide analogs, 472 patients without HCC history whose FIB-4 at baseline and 1 year of treatment was obtained were evaluated for the incidence of HCC. Results: The median FIB-4 was 2.00 at baseline and was significantly reduced to 1.58 at 1 year (P < 0.001), but the reduction was small at 2 years or later. When a receiver operating characteristic analysis of FIB-4 was performed to predict HCC within 5 years, the area under the curve of FIB-4 at 1 year was higher than that at baseline (0.676 vs. 0.599). The HCC incidence was significantly higher in patients with FIB-4 =1.58 than in those with FIB-4 <1.58 (14.8% vs. 3.6% at 10 years, P < 0.001). Additionally, an abnormal alanine aminotransferase (>= 31 U/L) at 1 year was an independent risk for HCC. When a fibrosis and alanine aminotransferase-1 (FAL-1) score was evaluated as an applicable number of FIB-4 =1.58, and alanine aminotransferase >= 31 as 0, 1, and 2, the HCC risk in patients with score 2 was significantly higher than in those with score 1 or score 0 (24.1% vs. 9.8% vs. 0.7% at 10 years, P < 0.001). Conclusions: FIB-4 >= 1.58 and alanine aminotransferase =31 at 1 year of nucleos (t)ide analog was an independent risk factor for HCC development, and a score using these factors stratified the risk of HCC.

Automated summary

This study evaluated the dynamics of the non-invasive liver fibrosis marker, the Fibrosis-4 (FIB-4) index, for predicting hepatocellular carcinoma (HCC) in patients with chronic hepatitis B virus infection. The results showed that a reduction in FIB-4 index and an abnormal alanine aminotransferase level at one year of nucleos(t)ide analog treatment were independent risk factors for HCC development. A score combining these factors stratified the risk of HCC.