Mortality, liver transplantation and hepatic complications in patients with treatment‐naïve chronic hepatitis B treated with entecavir vs tenofovir

Abstract

Few studies have directly compared the long‐term clinical outcomes of entecavir (ETV) and tenofovir disoproxil fumarate (TDF). This study aimed to compare the risk of mortality, liver transplantation, and hepatic complications including hepatocellular carcinoma (HCC) and hepatic decompensation between these drugs in treatment‐naïve chronic hepatitis B (CHB). We performed a longitudinal observational analysis of data from 1325 consecutive adult CHB patients with a cumulative adherence of ≥80% to treatment with ETV (n=721) or TDF (n=604) at a tertiary referral hospital in Ulsan, Korea, from January 1, 2007, through April 31, 2017. Among the patients, 708 were analyzed using propensity score matching with a ratio of 1:1. In the follow‐up period of up to 5 years, 5 patients (0.4%) died, 3 patients (0.2%) underwent liver transplantation (LT), and 54 patients (4.1%) developed HCC. Hepatic decompensation occurred in 24 (1.8%) patients. ETV therapy did not significantly differ from TDF therapy regarding the risk of liver‐related death or LT (HR 0.96; 95% CI, 0.23‐4.07; log‐rank P=0.955), HCC (HR, 1.36; 95% CI, 0.72‐2.56; log‐rank P=0.340), and hepatic decompensation (HR, 1.64; 95% CI, 0.67‐4.00; log‐rank P=0.276). In the 708 propensity‐matched pairs, ETV and TDF were also not significantly different with respect to the risk of mortality, LT, and hepatic complications. In this longitudinal observational study of 1325 patients with CHB, ETV and TDF therapy were not significantly different regarding the risk of mortality, HCC, LT, and hepatic decompensation.