Comparison of the long-term efficacy of tenofovir and entecavir in nucleos(t)ide analogue-naïve HBeAg-positive patients with chronic hepatitis B: A large, multicentre, randomized controlled trials

OBJECTIVE: We conducted this study to compare the efficacy and safety of entecavir and tenofovir in the treatment of treatment-naïve HBV e antigen (HBeAg)-positive patients with chronic hepatitis B (CHB) for 144 weeks. METHODS: A total of 320 treatment-naïve HBeAg-positive CHB patients who received randomly a single regimen of either entecavir capsule (ETV) (n = 160) or tenofovir disoproxil fumarate capsule (TDF) (n = 160) for 144 weeks were consecutively enrolled from 14 tertiary hospitals or university hospitals in China between January 2012 and December 2014. RESULTS: Two groups showed no difference in baseline characteristics. After 144 weeks of treatment, HBV DNA levels were similarly suppressed in both groups (ETV vs TDF; -6.6485 vs −6.692 log10IU/mL, P = .807). At the same time, both groups showed no difference in terms of the serologic and biochemical response. Of all patients, 2 dropped out due to adverse events and 5 experienced serious adverse reactions. CONCLUSION: Both capsules (ETV or TDF) were equally effective in nucleos(t)ide-naive CHB patients with a comparable side-effect profile even in a long-term of 144 weeks.