Choi J, et al. - Given that entecavir and tenofovir disoproxil fumarate have demonstrated similar effectiveness in attaining surrogate end points (including virologic response) and are recommended equally as first-line treatments for patients with chronic hepatitis B (CHB), researchers compared the impact of entecavir vs tenofovir on the risk of hepatocellular carcinoma (HCC) and death or liver transplant in patients with CHB infection. They found a significantly lower risk of HCC in association with tenofovir vs entecavir treatment, and these findings were validated in a hospital cohort.

Methods

• Researchers used data from the Korean National Health Insurance Service database and performed this nationwide historical population cohort study including treatment-naive adult patients with CHB who began treatment with entecavir (n = 11,464) or tenofovir disoproxil fumarate (n=12,692) between January 1, 2012 and December 31, 2014.
• They analyzed a hospital cohort of patients with CHB treated with entecavir (n=1,560) or tenofovir (n=1,141) in a tertiary referral center between January 1, 2010, and December 31 for validation.
• They also retrieved nationwide cohort data from January 1, 2010 to December 31, 2016 and hospital cohort data from January 1, 2010 to October 31, 2017.
• They assessed cumulative incidence rates of HCC and death and transplant rates.

Results

• Overall 24,156 subjects with mean (SD) age 48.9 (9.8) years were included; 15,120 patients (62.6%) were male.
• With mean (SD) age 48.8 (10.5) years and 1,657 males (61.3%), 2,701 patients comprised the hospital cohort.
• In the population cohort, a significantly lower annual incidence rate of HCC was observed in the tenofovir group (0.64 per 100 person-years [PY]) vs in the entecavir group (1.06 per 100 PY).
• Tenofovir therapy vs entecavir was found to be related to a significantly lower risk of HCC (hazard ratio [HR], 0.61; 95% CI, 0.54-0.70) and all-cause mortality or transplant (HR, 0.77; 95% CI, 0.65-0.92), by multivariable-adjusted analysis.
• Compared with the entecavir group, a significantly lower risk of HCC was shown by the tenofovir group in the 10,923–pair propensity score–matched population cohort (HR, 0.62; 95% CI, 0.54-0.70) and 869-pair propensity score–matched hospital cohort (HR, 0.68; 95% CI, 0.46-0.99).