Compassionate use of bedaquiline in the treatment of pulmonary XDR-TB

Danckers, Mauricio; Lesko, Melissa; Adamson, Rosemary; Leibert, Eric

doi:10.5588/ijtld.14.0338

Cited by 10 publications

(7 citation statements)

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“…The use of bedaquiline in a series of five Indian XDR-TB patients also showed striking improvement, with microbiological conversion [51]. The use of bedaquiline as a substitute for linezolid in the first XDR-TB case in the US was reported to allow the successful completion of adequate XDR-TB therapy with good tolerability and a favorable outcome 10 month after the treatment completion [52].…”

Section: Experience From Compassionate Usementioning

confidence: 96%

Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis

Nguyen

Cao

Akkerman

et al. 2016

Expert Review of Clinical Pharmacology

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Pubmed searches were conducted using search terms bedaquiline, diarylquinoline, R207910, and TMC207 was performed. Supplementary sources included World Health Organization, Clinicaltrial.gov, US Food and Drug Administration. Bedaquiline is an ATP synthase inhibitor specific for M. tuberculosis and some nontuberculous mycobacteria. It is metabolized by CYP3A4 and it's drug exposure can be influenced by inducers and inhibitors of this enzyme. Phase II studies showed promising results on efficacy of bedaquiline when being used in combination with a background regimen for MDR-TB. Main safety concerns include QTc prolongation and hepatotoxicity. Phase III trials are ongoing to confirm efficacy findings from phase II studies and provide additional evidence of safety and efficacy. Expert commentary: Critical data for long-term efficacy and safety are incomplete and scarce, supporting the cautious use of bedaquiline.

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Section: Experience From Compassionate Usementioning

confidence: 96%

Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis

Nguyen

Cao

Akkerman

et al. 2016

Expert Review of Clinical Pharmacology

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“…Following successful phase IIb trials [2] in 2013, the novel mycobacterial ATP-synthase inhibitor bedaquiline was approved in Europe and the USA for the first 24 weeks of MDR/XDR-TB treatment alongside a World Health Organization (WHO)-approved optimised background regimen. Phase III trials are ongoing but cohort data describe good early bacteriological outcomes in France [3, 4], Italy [5], the UK [6], the USA [7], India [8] and South Africa [9]. …”

mentioning

confidence: 99%

First experience of effectiveness and safety of bedaquiline for 18 months within an optimised regimen for XDR-TB

et al. 2016

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Extensively drug-resistant (XDR) tuberculosis (TB) is a type of multidrug-resistant (MDR) TB that is resistant to isoniazid, rifampicin, fluoroquinolones and at least one injectable second-line drug. There are insufficient antibiotics for effective combination therapy and mortality exceeds 70% [1]. Following successful phase IIb trials [2] in 2013, the novel mycobacterial ATP-synthase inhibitor bedaquiline was approved in Europe and the USA for the first 24 weeks of MDR/XDR-TB treatment alongside a World Health Organization (WHO)-approved optimised background regimen. Phase III trials are ongoing but cohort data describe good early bacteriological outcomes in France [3, 4], Italy [5], the UK [6], the USA [7], India [8] and South Africa [9].

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“…In the amended MDR-TB treatment protocol, drugs that have shown to be minimally ototoxic such as linezolid and bedaquiline have been spotlighted as first-option drugs. Bedaquiline is a significant breakthrough in TB treatment as the first drug in the new classes of TB treatments since 1971 developed specifically for MDR-TB (Danckers et al 2014). The amended MDR-TB treatment protocol has not been nationally implemented in numerous countries because it is expensive, although it has been approved by the WHO (Bistline 2018;WHO 2019).…”

Section: Solutions and Recommendationsmentioning

confidence: 99%

Community-based audiology services: An effective strategy for the prevention of hearing loss in rural communities

Joubert¹

2022

Preventive Audiology: An African Perspective

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Peer review declarationThe publisher (AOSIS) endorses the South African 'National Scholarly Book Publishers Forum Best Practice for Peer Review of Scholarly Books'. The manuscript underwent an evaluation to compare the level of originality with other published works and was subjected to rigorous two-step peer review before publication, with the identities of the reviewers not revealed to the editor(s) or author(s). The reviewers were independent of the publisher, editor(s), and author(s). The publisher shared feedback on the similarity report and the reviewers' inputs with the manuscript's editor(s) or author(s) to improve the manuscript. Where the reviewers recommended revision and improvements, the editor(s) or author(s) responded adequately to such recommendations. The reviewers commented positively on the scholarly merits of the manuscript and recommended that the manuscript be published. v Research justificationPreventive health care, where preventive audiology is positioned, contains strategies adopted and implemented for disease and disorder prevention. Hearing function can be negatively impacted by numerous factors, including lifestyle choices, environmental factors, genetic predisposition, the burden of disease and other causes. Frequently, hearing impairment can be prevented and its consequences significantly minimised by preventive measures. Such prevention commands conscientiously deliberate anticipatory actions that can fall under primordial, primary, secondary or tertiary levels of prevention. South Africa, as a resource-constrained low-and middle-income country (LMIC), still has a challenge of high numbers of individuals with preventable hearing impairment from the cradle to the grave. Numerous strategies exist for the prevention of hearing impairment across all ages and in various contexts. Preventive Audiology: An African Perspective is an original scholarly book that introduces the concept of preventive audiology, with a specific focus on the African context, which is in line with the South African re-engineered primary health care strategy and the World Health Organization's approach. The book reflects on contextually relevant and responsive evidence-based perspectives, grounded in an African context on preventive audiology, in four major ear-and-hearing burdens of disease within the South African context, namely, (1) early hearing detection and intervention (EHDI), (2) middle ear pathologies, (3) ototoxicity and (4) noise-induced hearing loss (NIHL). The book represents innovative research, seen from both South African and global perspectives. It offers new discourse and argues for a paradigm shift in how audiology is theorised and performed, particularly in LMIC contexts. The goal of this book is to motivate for a paradigm shift in how ear-and-hearing health care is approached within this LMIC context, while also arguing for Afrocentric best practice evidence that leads to next practice. For Afrocentric epistemology, which is a different narrative that is deliberately removed from Western epi...

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Compassionate use of bedaquiline in the treatment of pulmonary XDR-TB

Cited by 10 publications

References 0 publications

Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis

Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis

First experience of effectiveness and safety of bedaquiline for 18 months within an optimised regimen for XDR-TB

Community-based audiology services: An effective strategy for the prevention of hearing loss in rural communities

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