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Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis.
Expert Rev Clin Pharmacol. 2016 Aug; 9(8):1025-37.ER

Abstract

INTRODUCTION

Few innovative anti-microbial products have been brought to market in recent years to combat the global multidrug resistant-tuberculosis (MDR-TB) epidemic. Bedaquiline, a novel oral diarylquinoline, was approved by the US FDA as a part of combination therapy in adults with pulmonary MDR-TB based on phase II trials.

AREA COVERED

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.

Authors+Show Affiliations

a Department of Pharmacological, Medical and Agronomical Biotechnology , University of Science and Technology of Hanoi , Hanoi , Vietnam.b Department of Clinical Pharmacy , Hanoi University of Pharmacy , Hanoi , Vietnam.c University of Groningen, University Medical Center Groningen , Department Pulmonary Diseases and Tuberculosis , Groningen , The Netherlands. d University of Groningen, University Medical Center Groningen, Tuberculosis Center Beatrixoord , Haren , The Netherlands.e Division of Infection , Barts Health NHS Trust , London , UK.b Department of Clinical Pharmacy , Hanoi University of Pharmacy , Hanoi , Vietnam.f University of Groningen, University Medical Center Groningen, Clinical Pharmacy and Pharmacology , Groningen , The Netherlands.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

27322153

Citation

Nguyen, T V A., et al. "Bedaquiline as Part of Combination Therapy in Adults With Pulmonary Multi-drug Resistant Tuberculosis." Expert Review of Clinical Pharmacology, vol. 9, no. 8, 2016, pp. 1025-37.
Nguyen TV, Cao TB, Akkerman OW, et al. Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis. Expert Rev Clin Pharmacol. 2016;9(8):1025-37.
Nguyen, T. V., Cao, T. B., Akkerman, O. W., Tiberi, S., Vu, D. H., & Alffenaar, J. W. (2016). Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis. Expert Review of Clinical Pharmacology, 9(8), 1025-37. https://doi.org/10.1080/17512433.2016.1200462
Nguyen TV, et al. Bedaquiline as Part of Combination Therapy in Adults With Pulmonary Multi-drug Resistant Tuberculosis. Expert Rev Clin Pharmacol. 2016;9(8):1025-37. PubMed PMID: 27322153.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bedaquiline as part of combination therapy in adults with pulmonary multi-drug resistant tuberculosis. AU - Nguyen,T V A, AU - Cao,T B T, AU - Akkerman,O W, AU - Tiberi,S, AU - Vu,D H, AU - Alffenaar,J W C, Y1 - 2016/06/27/ PY - 2016/6/21/entrez PY - 2016/6/21/pubmed PY - 2017/3/11/medline KW - Bedaquiline KW - Mycobacterium tuberculosis KW - anti-tuberculosis drugs KW - multidrug-resistant tuberculosis KW - pharmacodynamics KW - pharmacokinetics SP - 1025 EP - 37 JF - Expert review of clinical pharmacology JO - Expert Rev Clin Pharmacol VL - 9 IS - 8 N2 - INTRODUCTION: Few innovative anti-microbial products have been brought to market in recent years to combat the global multidrug resistant-tuberculosis (MDR-TB) epidemic. Bedaquiline, a novel oral diarylquinoline, was approved by the US FDA as a part of combination therapy in adults with pulmonary MDR-TB based on phase II trials. AREA COVERED: 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. SN - 1751-2441 UR - https://www.unboundmedicine.com/medline/citation/27322153/Bedaquiline_as_part_of_combination_therapy_in_adults_with_pulmonary_multi_drug_resistant_tuberculosis_ L2 - http://www.tandfonline.com/doi/full/10.1080/17512433.2016.1200462 DB - PRIME DP - Unbound Medicine ER -