The risk of hepatocellular carcinoma is decreasing after the first 5 years of entecavir or tenofovir in Caucasians with chronic hepatitis B

ABSTRACT

Whether there is a change of hepatocellular carcinoma (HCC) incidence in chronic hepatitis B (CHB) patients under long-term therapy with potent nucleos(t)ide analogues is currently unclear. We therefore assessed the HCC incidence beyond year 5 of entecavir/tenofovir therapy and tried to determine possible factors associated with late HCC occurrence. This European 10-center, cohort study included 1951 adult Caucasian CHB patients without HCC at baseline who received entecavir/tenofovir for ≥1 year. Of them, 1205 (62%) patients without HCC within the first 5 years of therapy have been followed for 5-10 (median: 6.8) years. HCCs have been diagnosed in 101/1951 (5.2%) patients within the first 5 years and 17/1205 (1.4%) patients within 5-10 years. The yearly HCC incidence rate was 1.22% within and 0.73% after the first 5 years (p=0.050). The yearly HCC incidence rate did not differ within and after the first 5 years in non-cirrhotics (0.49% vs 0.47%, P=0.931), but it significantly declined in cirrhotics (3.22% vs 1.57%, p=0.039). All HCCs beyond year 5 developed in patients older than 50 years at entecavir/tenofovir onset. Older age, lower platelets at baseline and year 5 and liver stiffness ≥12 kPa at year 5 were independently associated with more frequent HCC development beyond year 5 in multivariable analysis. No patient with low PAGE-B score at baseline or year 5 developed HCC. In conclusion, the HCC risk is decreasing beyond year 5 of entecavir/tenofovir therapy in Caucasian CHB patients, particularly in those with compensated cirrhosis. Older age, especially age ≥50 years, lower platelets and liver stiffness ≥12 kPa at year 5 represent the main risk factors for late HCC development. This article is protected by copyright. All rights reserved.

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