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A regimen containing bedaquiline and delamanid compared to bedaquiline in patients with drug-resistant tuberculosis

Olatunde Olayanju, Aliasgar Esmail, Jason Limberis, Keertan Dheda
European Respiratory Journal 2020 55: 1901181; DOI: 10.1183/13993003.01181-2019
Olatunde Olayanju
1Centre for Lung Infection and Immunity, Division of Pulmonology, Dept of Medicine, and UCT Lung Institute and South African MRC/UCT Centre for the Study of Antimicrobial Resistance, Division of Pulmonology, University of Cape Town, Cape Town, South Africa
3Co-first author
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Aliasgar Esmail
1Centre for Lung Infection and Immunity, Division of Pulmonology, Dept of Medicine, and UCT Lung Institute and South African MRC/UCT Centre for the Study of Antimicrobial Resistance, Division of Pulmonology, University of Cape Town, Cape Town, South Africa
3Co-first author
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Jason Limberis
1Centre for Lung Infection and Immunity, Division of Pulmonology, Dept of Medicine, and UCT Lung Institute and South African MRC/UCT Centre for the Study of Antimicrobial Resistance, Division of Pulmonology, University of Cape Town, Cape Town, South Africa
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Keertan Dheda
1Centre for Lung Infection and Immunity, Division of Pulmonology, Dept of Medicine, and UCT Lung Institute and South African MRC/UCT Centre for the Study of Antimicrobial Resistance, Division of Pulmonology, University of Cape Town, Cape Town, South Africa
2Faculty of Infectious and Tropical Diseases, Dept of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, UK
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  • For correspondence: keertan.dheda@uct.ac.za
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Abstract

There are limited data on combining delamanid and bedaquiline in drug-resistant tuberculosis (DR-TB) regimens. Prospective long-term outcome data, including in HIV-infected persons, are unavailable.

We prospectively followed up 122 South African patients (52.5% HIV-infected) with DR-TB and poor prognostic features between 2014 and 2018. We examined outcomes and safety in those who received a bedaquiline-based regimen (n=82) compared to those who received a bedaquiline–delamanid combination regimen (n=40).

There was no significant difference in 6-month culture conversion (92.5% versus 81.8%; p=0.26) and 18-month favourable outcome rate (63.4% versus 67.5%; p=0.66) in the bedaquiline versus the bedaquiline–delamanid combination group, despite the latter having more advanced drug resistance (3.7% versus 22.5% resistant to at least five drugs; p=0.001) and higher pre-treatment failure rates (12.2% versus 52.5% with pre-treatment multidrug-resistant TB therapy failure; p<0.001). Although the proportion of prolongation of the QT interval corrected using Fridericia's formula was higher in the combination group (>60 ms from baseline (p=0.001) or >450 ms during treatment (p=0.001)), there were no symptomatic cases or drug withdrawals in either group. Results were similar in HIV-infected patients.

A bedaquiline–delamanid combination regimen showed comparable long-term safety compared to a bedaquiline-based regimen in patients with DR-TB, irrespective of HIV status. These data inform regimen selection in patients with DR-TB from TB-endemic settings.

Abstract

A bedaquiline–delamanid combination regimen in drug-resistant tuberculosis patients with poor prognostic factors showed comparable efficacy and safety to those in a bedaquiline-based regimen http://bit.ly/32j7Fyo

Footnotes

  • This article has supplementary material available from erj.ersjournals.com

  • Conflict of interest: O. Olayanju has no conflict of interest to declare.

  • Conflict of interest: A. Esmail has no conflict of interest to declare.

  • Conflict of interest: J. Limberis has no conflict of interest to declare.

  • Conflict of interest: K. Dheda has no conflict of interest to declare.

  • Support statement: This work was funded by South African Medical Research Council (grant: RFA-EMU-02-2017) and European and Developing Countries Clinical Trials Partnership (grant: TMA-2015SF-1043 and TMA-1051-TESAII).Funding information for this article has been deposited with the Crossref Funder Registry.

  • Received June 16, 2019.
  • Accepted October 9, 2019.
  • Copyright ©ERS 2020
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A regimen containing bedaquiline and delamanid compared to bedaquiline in patients with drug-resistant tuberculosis
Olatunde Olayanju, Aliasgar Esmail, Jason Limberis, Keertan Dheda
European Respiratory Journal Jan 2020, 55 (1) 1901181; DOI: 10.1183/13993003.01181-2019

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A regimen containing bedaquiline and delamanid compared to bedaquiline in patients with drug-resistant tuberculosis
Olatunde Olayanju, Aliasgar Esmail, Jason Limberis, Keertan Dheda
European Respiratory Journal Jan 2020, 55 (1) 1901181; DOI: 10.1183/13993003.01181-2019
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