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Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls.
Tuberculosis (Edinb). 2014 Jul; 94(4):357-62.T

Abstract

Treatment of multidrug-resistant tuberculosis (MDR-TB) is hindered by limited efficacy and significant toxicity of second-line drugs. The need for new therapeutic options is critical to combat the global MDR-TB epidemic. Bedaquiline is a novel oral diarylquinoline approved by Food and Drug administration (FDA) for the treatment of adults with pulmonary MDR-TB on the basis of Phase IIb trial data under the provisions of the accelerated approval regulations for serious or life-threatening conditions. The FDA advisory committee members voted unanimously on efficacy data based on surrogate measures, however they were split on the issues of safety of bedaquiline. Main safety concerns include QT interval prolongation, hepatic related adverse events, and excess mortality in bedaquiline treated patients. While bedaquiline approval is a story of many firsts and certainly a welcome addition to the existing arsenal of anti-TB agents, a cautiously optimistic approach is required to assess the risk benefit profile of the drug. Acceleration of further Phase III trials and clinical studies is imperative, as is timely analysis of emerging data on the real world use of the drug. This mini review outlines the clinical pharmacology of bedaquiline highlighting the potential promises and challenges that implicate the risk benefit profile of drug.

Authors+Show Affiliations

Dept. of Pharmacology, All India Institute of Medical Sciences, Bhopal 462024, India. Electronic address: akakkar.pharm@aiimsbhopal.edu.in.Dept. of Preventive and Social Medicine, Lady Hardinge Medical College, New Delhi, India.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

24841672

Citation

Kakkar, Ashish Kumar, and Neha Dahiya. "Bedaquiline for the Treatment of Resistant Tuberculosis: Promises and Pitfalls." Tuberculosis (Edinburgh, Scotland), vol. 94, no. 4, 2014, pp. 357-62.
Kakkar AK, Dahiya N. Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls. Tuberculosis (Edinb). 2014;94(4):357-62.
Kakkar, A. K., & Dahiya, N. (2014). Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls. Tuberculosis (Edinburgh, Scotland), 94(4), 357-62. https://doi.org/10.1016/j.tube.2014.04.001
Kakkar AK, Dahiya N. Bedaquiline for the Treatment of Resistant Tuberculosis: Promises and Pitfalls. Tuberculosis (Edinb). 2014;94(4):357-62. PubMed PMID: 24841672.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bedaquiline for the treatment of resistant tuberculosis: promises and pitfalls. AU - Kakkar,Ashish Kumar, AU - Dahiya,Neha, Y1 - 2014/04/18/ PY - 2013/11/12/received PY - 2014/04/06/accepted PY - 2014/5/21/entrez PY - 2014/5/21/pubmed PY - 2015/1/27/medline KW - Bedaquiline KW - Diarylquinoline KW - MDR-TB KW - Multidrug-resistant tuberculosis SP - 357 EP - 62 JF - Tuberculosis (Edinburgh, Scotland) JO - Tuberculosis (Edinb) VL - 94 IS - 4 N2 - Treatment of multidrug-resistant tuberculosis (MDR-TB) is hindered by limited efficacy and significant toxicity of second-line drugs. The need for new therapeutic options is critical to combat the global MDR-TB epidemic. Bedaquiline is a novel oral diarylquinoline approved by Food and Drug administration (FDA) for the treatment of adults with pulmonary MDR-TB on the basis of Phase IIb trial data under the provisions of the accelerated approval regulations for serious or life-threatening conditions. The FDA advisory committee members voted unanimously on efficacy data based on surrogate measures, however they were split on the issues of safety of bedaquiline. Main safety concerns include QT interval prolongation, hepatic related adverse events, and excess mortality in bedaquiline treated patients. While bedaquiline approval is a story of many firsts and certainly a welcome addition to the existing arsenal of anti-TB agents, a cautiously optimistic approach is required to assess the risk benefit profile of the drug. Acceleration of further Phase III trials and clinical studies is imperative, as is timely analysis of emerging data on the real world use of the drug. This mini review outlines the clinical pharmacology of bedaquiline highlighting the potential promises and challenges that implicate the risk benefit profile of drug. SN - 1873-281X UR - https://www.unboundmedicine.com/medline/citation/24841672/Bedaquiline_for_the_treatment_of_resistant_tuberculosis:_promises_and_pitfalls_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1472-9792(14)20416-1 DB - PRIME DP - Unbound Medicine ER -