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.

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.

journal_name

Medicine (Baltimore)

journal_title

Medicine

authors

Cai D,Pan C,Yu W,Dang S,Li J,Wu S,Jiang N,Wang M,Zhang Z,Lin F,Xin S,Yang Y,Shen B,Ren H

doi

10.1097/MD.0000000000013983

subject

Has Abstract

pub_date

2019-01-01 00:00:00

pages

e13983

issue

1

eissn

0025-7974

issn

1536-5964

pii

00005792-201901040-00060

journal_volume

98

pub_type

杂志文章,多中心研究,随机对照试验

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