The authors were interested in whether there has been a change in hepatocellular carcinoma (HCC) incidence in chronic hepatitis B (CHB) patients caused by long-term therapy with nucleos(t)ide analogues. They examined the HCC incidence beyond year 5 of entecavir/tenofovir therapy to determine the possible factors associated with late HCC occurrence. This cohort study included 1951 adult Caucasian CHB patients without HCC at baseline who received entecavir/tenofovir for ≥1 year. 62% of the patients without HCC in the first 5 years of therapy were followed for a median of 6.8 years. HCCs were diagnosed in 5.2% of patients within the first 5 years and 1.4% of patients within 5-10 years. The annual HCC incidence rate was therefore significantly different at 1.22% within and 0.73% after the first 5 years. The annual HCC incidence rate did not differ within and after the first 5 years in patients without cirrhosis, but it did significantly decline in patients with cirrhosis (3.22% vs. 1.57%). All HCCs beyond year 5 developed in patients older than 50 years at entecavir/tenofovir treatment initiation. Older age, lower platelets at baseline and year 5, and liver stiffness ≥12 kPa at year 5 were all independently associated with more frequent HCC development beyond year 5. None of the patients with a low PAGE-B score at baseline or at year 5 developed HCC. Therefore HCC risk is decreasing beyond year 5 of entecavir/tenofovir therapy in Caucasian CHB patients, particularly those with compensated cirrhosis. Older age, especially age ≥50 years, lower platelets and liver stiffness ≥12 kPa at year 5 are the main risk factors for late HCC development.
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