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Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results.

Abstract：

BACKGROUND:In China, the clinical management of chronic hepatitis B (CHB) is complicated by the use of variousnucleoside/nucleotide analogue (NUC) regimens in treatment-naive patients, including NUCs with low genetic barriers to resistance, with/without add-on therapy and de novo NUC combinations. This longitudinal observational study therefore investigated the real-world clinical management and efficacy of NUC therapy in treatment-naive CHB patients in China. METHODS:Treatment-naive CHB patients initiated on NUC therapy were enrolled from 63 hospitals in tier-2 Chinese cities. Demographic and treatment-specific data were collected, with the objective of reporting real-world treatment patterns and comparing the effectiveness of entecavir (ETV) treatment and lamivudine (LAM)-based treatment. We herein report the first-year data. RESULTS:3,408 NUC-naive patients were enrolled and treated with NUCs (53% ETV, 18% LAM-based, 29% other). Overall, 6.6% of patients modified their initial treatment, with ETV having lower rates of treatment modification than other major NUCs (P<0.05). At week 52, the virological response rate was higher with ETV than with LAM-based treatment (77.0% versus 61.4%; P<0.0001). LAM-based treatment was associated with a higher probability of virological breakthrough and genotypic resistance (21.4% and 19.6%, respectively) than ETV (1.6% and 0.1%, respectively; P<0.0001). Treatment-related adverse events or serious adverse events were uncommon. CONCLUSIONS:In this nationwide observational study, more than 50% of patients with CHB in tier-2 city hospitals in China initially received ETV therapy. Consistent with clinical trial results, ETV was more effective than LAM-based treatments in a real-world setting, with the rate of treatment modification being relatively low in ETV-treated patients. ClinicalTrials.gov Identifier: NCT01726439.

journal_name

Antivir Ther

journal_title

Antiviral therapy

authors

Jia J,Tang H,Ning Q,Jiang J,Dou X,Zhang M,Zhang S,Shang J,Lu W,Ye Y,Wang X,Li M,Liu J,Bo Q,Tan W,EVOLVE Study Group.

doi

10.3851/IMP3205

subject

Has Abstract

pub_date

2018-01-01 00:00:00

pages

201-209

issue

eissn

1359-6535

issn

2040-2058

journal_volume

pub_type

临床试验,杂志文章,多中心研究

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Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results.