AFP Specificity for HCC Surveillance is Increased by Mitigating Liver Injury Among Treated Chronic Hepatitis B Patients with Elevated AFP

Objective: The aim of this study was to assess AFP response in chronic hepatitis B (CHB) patients with baseline positive AFP (≥7 ng/mL) who received antiviral therapy thereafter.

Methods: A cohort study was conducted to assess AFP response in CHB patients who had baseline positive AFP and got antiviral therapy.

Results: This retrospective study enrolled 302 antiviral-treatment-naïve CHB patients with positive AFP. After a 12-month antiviral treatment, 144 patients normalized AFP during follow-up while the rest remained AFP-positive. There were no significant differences in baseline characteristics and virologic and ALT responses to antiviral therapy between the two groups. During a mean follow-up of 34 ± 6 months, 16 patients (5.3%) in this cohort developed HCC, and 14 (8.9%) of them emerged in the AFP positive group. There was a significant difference (=0.004) in HCC occurrence between AFP normalized and non-normalized groups after treatment. Univariate and multivariate analyses revealed that cirrhosis (HR=9.983, 95% CI=3.609-27.617, <0.001), and non-AFP response to antiviral treatment (HR=6.517, 95% CI=1.475-28.784, =0.013) were two independent factors associated with HCC occurrence.

Conclusions: To our knowledge, this is the first investigator-initiated cohort study to assess the performance of on-treatment AFP in CHB patients with baseline positive AFP. In contrast to the criticism that AFP is neither sensitive nor specific, the current study has provided important evidence that on-antiviral-treatment AFP normalization is a specific protective marker for HCC in patients with HBV-related chronic liver diseases who started antiviral therapy thereafter.