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Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis.
Eur Respir J 2016; 47(2):564-74ER

Abstract

Bedaquiline, a diarylquinoline, improved cure rates when added to a multidrug-resistant tuberculosis (MDR-TB) treatment regimen in a previous placebo-controlled, phase 2 trial (TMC207-C208; NCT00449644). The current phase 2, multicenter, open-label, single-arm trial (TMC207-C209; NCT00910871) reported here was conducted to confirm the safety and efficacy of bedaquiline.Newly diagnosed or previously treated patients with MDR-TB (including pre-extensively drug-resistant (pre-XDR)-TB or extensively drug-resistant (XDR)-TB) received bedaquiline for 24 weeks with a background regimen of anti-TB drugs continued according to National TB Programme treatment guidelines. Patients were assessed during and up to 120 weeks after starting bedaquiline.Of 233 enrolled patients, 63.5% had MDR-TB, 18.9% had pre-XDR-TB and 16.3% had XDR-TB, with 87.1% having taken second-line drugs prior to enrolment. 16 patients (6.9%) died. 20 patients (8.6%) discontinued before week 24, most commonly due to adverse events or MDR-TB-related events. Adverse events were generally those commonly associated with MDR-TB treatment. In the efficacy population (n=205), culture conversion (missing outcome classified as failure) was 72.2% at 120 weeks, and 73.1%, 70.5% and 62.2% in MDR-TB, pre-XDR-TB and XDR-TB patients, respectively.Addition of bedaquiline to a background regimen was well tolerated and led to good outcomes in this clinically relevant patient cohort with MDR-TB.

Authors+Show Affiliations

Medical Research Council and Kwazulu Research Institute for TB and HIV (K-RITH), Durban, South Africa Alex.Pym@k-rith.org.Division of Medical Physiology and Dept of Science and Technology/National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research and Medical Research Council Centre for Tuberculosis Research, Faculty of Medicine and Health Sciences, University of Stellenbosch, Cape Town, South Africa.Tuberculosis Dept, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumour Research Institute, Beijing, China.Clinical HIV Research Unit, Dept of Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.Tartu University Lung Hospital, Tartu, Estonia.Chest Disease Institute, Ministry of Public Health, Nonthaburi, Thailand.Central Tuberculosis Research Institute, Russian Academy of Medical Sciences, Moscow, Russia.Janssen Infectious Diseases BVBA, Beerse, Belgium.Janssen Research & Development LLC, Titusville, NJ, USA.Janssen Research & Development LLC, Titusville, NJ, USA.Janssen Infectious Diseases BVBA, Beerse, Belgium.Janssen Infectious Diseases BVBA, Beerse, Belgium.Janssen Infectious Diseases BVBA, Beerse, Belgium.Janssen Infectious Diseases BVBA, Beerse, Belgium.Janssen Infectious Diseases BVBA, Beerse, Belgium.Janssen Research & Development LLC, Titusville, NJ, USA.No affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26647431

Citation

Pym, Alexander S., et al. "Bedaquiline in the Treatment of Multidrug- and Extensively Drug-resistant Tuberculosis." The European Respiratory Journal, vol. 47, no. 2, 2016, pp. 564-74.
Pym AS, Diacon AH, Tang SJ, et al. Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. Eur Respir J. 2016;47(2):564-74.
Pym, A. S., Diacon, A. H., Tang, S. J., Conradie, F., Danilovits, M., Chuchottaworn, C., ... Dannemann, B. (2016). Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. The European Respiratory Journal, 47(2), pp. 564-74. doi:10.1183/13993003.00724-2015.
Pym AS, et al. Bedaquiline in the Treatment of Multidrug- and Extensively Drug-resistant Tuberculosis. Eur Respir J. 2016;47(2):564-74. PubMed PMID: 26647431.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bedaquiline in the treatment of multidrug- and extensively drug-resistant tuberculosis. AU - Pym,Alexander S, AU - Diacon,Andreas H, AU - Tang,Shen-Jie, AU - Conradie,Francesca, AU - Danilovits,Manfred, AU - Chuchottaworn,Charoen, AU - Vasilyeva,Irina, AU - Andries,Koen, AU - Bakare,Nyasha, AU - De Marez,Tine, AU - Haxaire-Theeuwes,Myriam, AU - Lounis,Nacer, AU - Meyvisch,Paul, AU - Van Baelen,Ben, AU - van Heeswijk,Rolf P G, AU - Dannemann,Brian, AU - ,, Y1 - 2015/12/02/ PY - 2015/05/08/received PY - 2015/10/02/accepted PY - 2015/12/10/entrez PY - 2015/12/10/pubmed PY - 2016/11/2/medline SP - 564 EP - 74 JF - The European respiratory journal JO - Eur. Respir. J. VL - 47 IS - 2 N2 - Bedaquiline, a diarylquinoline, improved cure rates when added to a multidrug-resistant tuberculosis (MDR-TB) treatment regimen in a previous placebo-controlled, phase 2 trial (TMC207-C208; NCT00449644). The current phase 2, multicenter, open-label, single-arm trial (TMC207-C209; NCT00910871) reported here was conducted to confirm the safety and efficacy of bedaquiline.Newly diagnosed or previously treated patients with MDR-TB (including pre-extensively drug-resistant (pre-XDR)-TB or extensively drug-resistant (XDR)-TB) received bedaquiline for 24 weeks with a background regimen of anti-TB drugs continued according to National TB Programme treatment guidelines. Patients were assessed during and up to 120 weeks after starting bedaquiline.Of 233 enrolled patients, 63.5% had MDR-TB, 18.9% had pre-XDR-TB and 16.3% had XDR-TB, with 87.1% having taken second-line drugs prior to enrolment. 16 patients (6.9%) died. 20 patients (8.6%) discontinued before week 24, most commonly due to adverse events or MDR-TB-related events. Adverse events were generally those commonly associated with MDR-TB treatment. In the efficacy population (n=205), culture conversion (missing outcome classified as failure) was 72.2% at 120 weeks, and 73.1%, 70.5% and 62.2% in MDR-TB, pre-XDR-TB and XDR-TB patients, respectively.Addition of bedaquiline to a background regimen was well tolerated and led to good outcomes in this clinically relevant patient cohort with MDR-TB. SN - 1399-3003 UR - https://www.unboundmedicine.com/medline/citation/26647431/Bedaquiline_in_the_treatment_of_multidrug__and_extensively_drug_resistant_tuberculosis_ L2 - http://erj.ersjournals.com/cgi/pmidlookup?view=long&pmid=26647431 DB - PRIME DP - Unbound Medicine ER -