Long-term outcomes (HCC incidence, survival, HBsAg loss) in 1,644 Caucasian patients with chronic hepatitis B (CHB) treated with entecavir or tenofovir, with 903 followed beyond year 10 (mean 14±2 years) in the PAGE-B cohort.
HCC cumulative incidence was 10.9% at 10 years and 13.2% at 15 years, but the HCC incidence rate fell significantly after year 10 (1.25 → 0.55/100 person-years, P<0.001). HBsAg loss rates actually increased after year 10 (0.94 → 1.42/100 PYs, P=0.025), reaching 14.3% cumulative incidence at 15 years. HCC was the main driver of mortality.
Cohort is exclusively Caucasian, limiting generalizability to Asian or African populations where CHB epidemiology and HCC risk differ. No control arm; patients who did not reach year 10 (n=741) differ systematically from those who did, introducing potential selection bias despite inverse probability weighting.
Even after 10 years of entecavir or tenofovir, CHB patients—especially older patients and those with low baseline platelets or diabetes—remain at meaningful HCC risk and should continue surveillance. HBsAg loss rates modestly increase after year 10, so long-term NA therapy should not be prematurely stopped in HBsAg-positive patients.
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