Antiviral therapy has been shown to improve the prognosis of hepatitis B virus (HBV)
DNA-positive
hepatocellular carcinoma (HCC) after radical treatment, but
antiviral treatments require further optimization. This study aimed to evaluate the efficacies of different
antiviral strategies with HCC patients after
hepatectomy/ablation. This prospective, randomized, controlled and multi-centre trial enrolled HBV
DNA-positive primary HCC patients after
hepatectomy/ablation between January 2007 and January 2009. Patients were divided into four groups: early combination (
entecavir plus Peg-
interferon [IFN]α-2a co-administration during year 1); late combination (addition of Peg-IFNα-2a for 48 weeks after 1 year of
entecavir); nucleos(t)ide analogue[NA] monotherapy; and non-
antiviral treatment. Primary endpoints included recurrence-free survival and overall survival. A total of 447 patients were enrolled. The 2-year and 8-year recurrence-free survival and 8-year overall survival rates were significantly higher in the early combination group than in the other two
antiviral groups (P < .05). After 48-week treatment, more patients achieved an
HBsAg reduction >1500 IU/mL and the mean
HBsAg level was significantly lower in the early combination group compared with the late combination and NA monotherapy groups (P < .05). Multivariate analysis showed that early combination
therapy and a reduction in
HBsAg by >1500 IU/mL after 48 weeks of
therapy correlated with reduced mortality and disease recurrence. Early introduction of combination
antiviral treatment may represent a more effective therapeutic strategy for patients with HBV
DNA-positive HCC after
hepatectomy/ablation. A reduction in
HBsAg by >1500 IU/mL after 48-week treatment is associated with reduced mortality and disease recurrence of HBV
DNA-positive HCC patients after
hepatectomy/ablation.