Long-term efficacy and safety of tenofovir disoproxil fumarate in Chinese patients with chronic hepatitis B: 5-year results. View Full Text


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Article Info

DATE

2019-04-11

AUTHORS

Xieer Liang, Zhiliang Gao, Qing Xie, Jiming Zhang, Jifang Sheng, Jun Cheng, Chengwei Chen, Qing Mao, Wei Zhao, Hong Ren, Deming Tan, Junqi Niu, Shijun Chen, Chen Pan, Hong Tang, Hao Wang, Yimin Mao, Jidong Jia, Qin Ning, Min Xu, Shanming Wu, Jun Li, Xinxin Zhang, Wenyan Zhang, Cui Xiong, Jinlin Hou

ABSTRACT

BACKGROUND AND AIM: Long-term treatment with tenofovir disoproxil fumarate (TDF) has demonstrated suppression of viral replication outside of China. This study aims to assess efficacy, resistance and safety of TDF for up to 240 weeks in Chinese patients with chronic hepatitis B virus (HBV) infection. METHODS: Patients (HBeAg-positive or HBeAg-negative) who were randomised to receive TDF 300 mg or adefovir dipivoxil (ADV) 10 mg once daily in the 48-week double-blind phase (N = 498) were eligible to enter the open-label TDF phase (TDF-TDF and ADV-TDF groups) for additional 192 weeks. RESULTS: Overall, 457/512 (89.3%) randomised patients completed 240 weeks of treatment. Virological suppression was achieved in 84.5% and 87.9% in HBeAg-positive patients and 89.6% and 89.5% in HBeAg-negative patients in TDF-TDF and ADV-TDF groups, respectively, at week 240. The majority of patients from both groups had normalized alanine transaminase levels. More patients had HBeAg loss (41.7% vs. 36.4%) and HBeAg seroconversion (32.0% vs. 28.3%) in TDF-TDF than in ADV-TDF group, respectively. Only one HBeAg-positive patient in TDF-TDF group had HBsAg loss at week 240. No evidence of resistance to TDF was observed. The incidence of adverse events was similar in both groups (TDF-TDF, 56.4% vs. ADV-TDF, 51.6%). One patient had serum creatinine elevation ≥ 0.5 mg/dL above baseline, and three patients had confirmed grade 3/4 phosphorus abnormalities (< 2 mg/dL). CONCLUSION: In Chinese patients with chronic HBV, long-term treatment with TDF showed sustained viral suppression without development of resistance up to 240 weeks. No new safety concerns were found with TDF in this patient population. Clinical Trial Registration ClinicalTrial.gov Identifier NCT01300234; GSK Clinical Study Register 114648. More... »

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12072-019-09943-6

DOI

http://dx.doi.org/10.1007/s12072-019-09943-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1113378629

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30977033


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Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s12072-019-09943-6'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s12072-019-09943-6'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s12072-019-09943-6'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s12072-019-09943-6'


 

This table displays all metadata directly associated to this object as RDF triples.

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316 https://www.grid.ac/institutes/grid.452223.0 schema:alternateName Xiangya Hospital Central South University
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319 https://www.grid.ac/institutes/grid.459778.0 schema:alternateName Mengchao Hepatobiliary Hospital
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322 https://www.grid.ac/institutes/grid.470110.3 schema:alternateName Shanghai Public Health Clinical Center
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325 https://www.grid.ac/institutes/grid.64924.3d schema:alternateName Jilin University
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