Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients Receiving Entecavir or Tenofovir Treatment Showing Maintained Virological Response = Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients Receiving Entecavir or Tenofovir Treatment Showing Maintained Virological Response

다국어 초록 (Multilingual Abstract)

Aims: Observational studies suggested tenofovir may have favorable efficacy for the prevention of (HCC) development compared to entecavir. However, mechanism of both drugs is suppression of hepatitis B virus (HBV) replication and whether class effect exist despite same mechanism of action remains controversial, and data from randomized controlled trial are lacking. As a results, whether change in therapy is required for those who shows good virological response to entecavir treatment in order to further reduce HCC risk remains unknown.
Methods: A retrospective cohort of 1,336 treatment-naïve chronic HBV mono-infected adults patients without malignancy or organ transplantation at baseline who started entecavir or tenofovir treatment between June 2012 to December 2015, and showed maintained virological response during follow-up were analyzed. Primary outcome was comparison of entecavir and tenofovir on incident HCC during follow-up.
Results: During a median 4.4 years of follow-up (range: 1.0- 7.4 years) after achieving virological response, 99 patients developed HCC. The 5-years cumulative HCC incidence rate was 7.3% and 6.3% for entecavir and tenofovir group, with similar risk of HCC between two groups (adjusted hazard ratio: 0.82; 95% confidence interval 0.52 to 1.28; P=0.39). The risk of HCC was similar in in propensity score-matched cohort (entecavir = 570; tenfovir =570; hazard ratio 1.02; 95% confidence interval 0.68 to 1.52; P=0.94). In subgroup analysis, HCC risk was similar between two drugs in both patients with and without cirrhosis.
Conclusions: In patients who showed good virological response, we observed no difference in the risk of HCC between two drugs. This observation suggest class effect may not exist and imply entecavir is equally effective as tenofovir for the prevention of HCC among those with good virological response.