Superior Efficacy of Besifovir in Reducing Hepatocellular Carcinoma Risk Compared to Tenofovir in Chronic Hepatitis B Patients: A Nationwide Cohort Study.

BACKGROUND

Besifovir dipivoxil maleate (BSV) is a novel therapeutic option for the treatment of chronic hepatitis B (CHB). However, its long-term effectiveness in reducing the risk of hepatocellular carcinoma (HCC) remains unclear.

METHODS

We conducted a retrospective cohort study using the Korean Health Insurance Review and Assessment Service database from 2018 to 2022. A total of 32,383 patients with CHB were included (BSV, n = 2,358; tenofovir disoproxil fumarate [TDF], n = 30,025). Propensity score matching was conducted at a 1:3 ratio to minimize selection bias. The primary outcome was the incidence of HCC, with cirrhosis development as the secondary endpoint.

RESULTS

In the overall population, 57 cases of HCC were reported in the BSV group (2,358 individuals, 5,918 person-years), while 1,268 cases of HCC were reported in the TDF group (30,025 individuals, 83,587 person-years). After propensity score matching, the incidence of HCC was significantly lower in the BSV group (9.63 per 1,000 person-years; 95% confidence interval [CI], 7.43-12.49) than in the TDF group (15.36 per 1,000 person-years; 95% CI, 13.72-17.18), with an incidence rate ratio of 1.59 (P = 0.001). This protective effect remained consistent in both cirrhotic (hazard ratio [HR], 1.609; P = 0.028) and non-cirrhotic subgroups (HR, 1.831; P = 0.002).

CONCLUSION

BSV treatment demonstrated superior efficacy in reducing the risk of HCC compared to TDF, regardless of baseline cirrhosis status. These findings suggest that BSV may provide enhanced protection against HCC in patients with CHB.