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Challenges of using new and repurposed drugs for the treatment of multidrug-resistant tuberculosis in children

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Title: Challenges of using new and repurposed drugs for the treatment of multidrug-resistant tuberculosis in children
Authors: Schaaf, HS
Garcia-Prats, AJ
McKenna, L
Seddon, JA
Item Type: Journal Article
Abstract: Introduction: New and repurposed antituberculosis drugs are urgently needed to more safely and effectively treat multidrug-resistant (MDR) tuberculosis (TB) in children. Multiple challenges limit timely access to new MDR-TB treatments in children. Areas covered: Diagnosis of MDR-TB in children remains a barrier, with few children with MDR-TB diagnosed and treated. Other barriers to timely access to new and repurposed drugs are discussed, and include delayed initiation of paediatric trials, limited funding for paediatric drug development, fragmented regulatory systems and operational challenges. The status of access to current repurposed and novel drugs is presented. Expert commentary: More timely initiation of paediatric trials is needed and paediatric work should happen and be funded in parallel with each phase of adult trials. Better quality data, increased regulator resources and expertise, harmonization of regulatory requirements across borders/organisations and registration fee waivers would improve registration timelines. Improved diagnosis, recording and reporting will establish better demand. Improved systems for procurement and supply chain management would reduce in-country operational barriers to getting medications to children. The challenges must be addressed to ensure timely and equitable access to new drugs and regimens that are urgently needed for effective, safe and shorter treatment of children with MDR-TB.
Issue Date: 27-Dec-2017
Date of Acceptance: 20-Dec-2017
URI: http://hdl.handle.net/10044/1/58165
DOI: https://dx.doi.org/10.1080/17512433.2018.1421067
ISSN: 1751-2433
Publisher: Taylor & Francis
Start Page: 233
End Page: 244
Journal / Book Title: Expert Review of Clinical Pharmacology
Volume: 11
Issue: 3
Copyright Statement: © 2017 Informa UK Limited, trading as Taylor & Francis Group. This is an Accepted Manuscript of an article published by Taylor & Francis in Expert Review of Clinical Pharmacology on 20 Dec 2017, available online: https://dx.doi.org/10.1080/17512433.2018.1421067
Keywords: Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
Tuberculosis
multidrug-resistant tuberculosis
children
new and repurposed drugs
challenges
EARLY BACTERICIDAL ACTIVITY
SOUTH-AFRICA
PHARMACOKINETICS
BEDAQUILINE
CLOFAZIMINE
DELAMANID
HIV
MOXIFLOXACIN
METAANALYSIS
MANAGEMENT
Adult
Antitubercular Agents
Child
Drug Design
Drug Repositioning
Health Services Accessibility
Humans
Tuberculosis, Multidrug-Resistant
1115 Pharmacology And Pharmaceutical Sciences
Publication Status: Published
Appears in Collections:Department of Medicine
Faculty of Medicine



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