Medicine (Baltimore). 2019 Jan;98(1):e13983. doi: 10.1097/MD.0000000000013983.
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.
Cai D1, Pan C2, Yu W3, Dang S4, Li J5, Wu S6, Jiang N7, Wang M8, Zhang Z9, Lin F10, Xin S11, Yang Y12, Shen B13, Ren H1.
Author information
1
The Second Affiliated Hospital of Chongqing Medical University, Chongqing.
2
Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou.
3
The Eighth People's Hospital of Guangzhou.
4
The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an.
5
The Second People's Hospital of Tianjin.
6
Shanghai Public Health Clinical Center Shanghai.
7
Sichuan Provincial People's Hospital, Chengdu.
8
No.81 Hospital of PLA.
9
Jinan Infectious Disease Hospital.
10
Hainan General Hospital, Haikou.
11
No.302 Hospital of PLA, Beijing.
12
The Second Hospital of Nanjing, Nanjing.
13
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
Abstract
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.