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Standardised shorter regimens versus individualised longer regimens for rifampin- or multidrug-resistant tuberculosis

Syed Abidi, Jay Achar, Mourtala Mohamed Assao Neino, Didi Bang, Andrea Benedetti, Sarah Brode, Jonathon R. Campbell, Esther C. Casas, Francesca Conradie, Gunta Dravniece, Philipp du Cros, Dennis Falzon, Ernesto Jaramillo, Christopher Kuaban, Zhiyi Lan, Christoph Lange, Pei Zhi Li, Mavluda Makhmudova, Aung Kya Jai Maug, Dick Menzies, Giovanni Battista Migliori, Ann Miller, Bakyt Myrzaliev, Norbert Ndjeka, Jürgen Noeske, Nargiza Parpieva, Alberto Piubello, Valérie Schwoebel, Welile Sikhondze, Rupak Singla, Mahamadou Bassirou Souleymane, Arnaud Trébucq, Armand Van Deun, Kerri Viney, Karin Weyer, Betty Jingxuan Zhang, Faiz Ahmad Khan
European Respiratory Journal 2020 55: 1901467; DOI: 10.1183/13993003.01467-2019
Syed Abidi
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Jay Achar
3Médecins Sans Frontières/Doctors without Borders, London, UK
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Mourtala Mohamed Assao Neino
4National Tuberculosis Program, Niamey, Niger
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Didi Bang
5International Reference Laboratory of Mycobacteriology, National Centre for Antimicrobials and Infection Control, Statens Serum Institut, Copenhagen, Denmark
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  • ORCID record for Didi Bang
Andrea Benedetti
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
6Dept of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, QC, Canada
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Sarah Brode
7West Park Healthcare Centre, University Health Network and University of Toronto, Toronto, ON, Canada
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Jonathon R. Campbell
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Esther C. Casas
8Médecins Sans Frontières/Doctors without Borders, Amsterdam, The Netherlands
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Francesca Conradie
9Dept of Medicine, University of Witswatersrand, Johannesburg, South Africa
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Gunta Dravniece
10KNCV TB Foundation, The Hague, The Netherlands
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Philipp du Cros
3Médecins Sans Frontières/Doctors without Borders, London, UK
11Burnet Institute, Melbourne, Australia
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Dennis Falzon
12World Health Organization, Geneva, Switzerland
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Ernesto Jaramillo
12World Health Organization, Geneva, Switzerland
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Christopher Kuaban
13Faculty of Health Sciences, The University of Bamenda, Bambili, Cameroon
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Zhiyi Lan
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Christoph Lange
14Research Center Borstel, Leibniz Lung Center, Borstel, Germany
15German Center for Infection Research Clinical TB Unit, Borstel, Germany
16Respiratory Medicine and International Health, University of Lübeck, Lübeck, Germany
17Dept of Medicine, Karolinska Institute, Stockholm, Sweden
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Pei Zhi Li
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Mavluda Makhmudova
18KNCV Tajikistan, Dushanbe, Tajikistan
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Aung Kya Jai Maug
19Damien Foundation, Brussels, Belgium
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Dick Menzies
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Giovanni Battista Migliori
20WHO Collaborating Centre for Tuberculosis and Lung Diseases, Istituti Clinici Scientifici Maugeri IRCCS, Tradate, Italy
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Ann Miller
21Dept of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA
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Bakyt Myrzaliev
22KNCV TB Foundation, Branch Office KNCV in Kyrgyzstan, Bishkek, Kyrgyzstan
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Norbert Ndjeka
23National TB Programme, Republic of South Africa, Pretoria, South Africa
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Jürgen Noeske
24National Tuberculosis Programme, Yaounde, Cameroon
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Nargiza Parpieva
25National TB Institute, Tashkent, Uzbekistan
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Alberto Piubello
19Damien Foundation, Brussels, Belgium
26International Union Against Tuberculosis and Lung Disease, Paris, France
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Valérie Schwoebel
26International Union Against Tuberculosis and Lung Disease, Paris, France
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Welile Sikhondze
27National TB Control Program, Eswatini Ministry of Health, Mbabane, Swaziland
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Rupak Singla
28National Institute of Tuberculosis and Respiratory Diseases, Delhi, India
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Mahamadou Bassirou Souleymane
19Damien Foundation, Brussels, Belgium
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Arnaud Trébucq
26International Union Against Tuberculosis and Lung Disease, Paris, France
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Armand Van Deun
29Mycobacteriology Unit, Institute of Tropical Medicine, Antwerp, Belgium
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Kerri Viney
30The University of Sydney, Sydney, Australia
31Karolinska Institutet, Stockholm, Sweden
32Australian National University, Canberra, Australia
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Karin Weyer
12World Health Organization, Geneva, Switzerland
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Betty Jingxuan Zhang
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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Faiz Ahmad Khan
1McGill International TB Centre, Montreal, QC, Canada
2Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, McGill University and Research Institute of the McGill University Health Centre, Montreal, QC, Canada
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  • For correspondence: faiz.ahmadkhan@mcgill.ca
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Abstract

We sought to compare the effectiveness of two World Health Organization (WHO)-recommended regimens for the treatment of rifampin- or multidrug-resistant (RR/MDR) tuberculosis (TB): a standardised regimen of 9–12 months (the “shorter regimen”) and individualised regimens of ≥20 months (“longer regimens”).

We collected individual patient data from observational studies identified through systematic reviews and a public call for data. We included patients meeting WHO eligibility criteria for the shorter regimen: not previously treated with second-line drugs, and with fluoroquinolone- and second-line injectable agent-susceptible RR/MDR-TB. We used propensity score matched, mixed effects meta-regression to calculate adjusted odds ratios and adjusted risk differences (aRDs) for failure or relapse, death within 12 months of treatment initiation and loss to follow-up.

We included 2625 out of 3378 (77.7%) individuals from nine studies of shorter regimens and 2717 out of 13 104 (20.7%) individuals from 53 studies of longer regimens. Treatment success was higher with the shorter regimen than with longer regimens (pooled proportions 80.0% versus 75.3%), due to less loss to follow-up with the former (aRD −0.15, 95% CI −0.17– −0.12). The risk difference for failure or relapse was slightly higher with the shorter regimen overall (aRD 0.02, 95% CI 0–0.05) and greater in magnitude with baseline resistance to pyrazinamide (aRD 0.12, 95% CI 0.07–0.16), prothionamide/ethionamide (aRD 0.07, 95% CI −0.01–0.16) or ethambutol (aRD 0.09, 95% CI 0.04–0.13).

In patients meeting WHO criteria for its use, the standardised shorter regimen was associated with substantially less loss to follow-up during treatment compared with individualised longer regimens and with more failure or relapse in the presence of resistance to component medications. Our findings support the need to improve access to reliable drug susceptibility testing.

Abstract

Standardised shorter regimens for RR/MDR-TB had substantially lower risk of loss to follow-up than individualised longer regimens, but also higher risk of failure or relapse if there was resistance to component drugs http://bit.ly/2RQgXzq

Footnotes

  • This article has an editorial commentary: https://doi.org/10.1183/13993003.00224-2020

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

  • Author contributions: F. Ahmad Khan, D. Menzies, A. Benedetti, P. du Cros, J.R. Campbell, D. Falzon, Z. Lan, A. Piubello, V. Schwoebel and A. Trébucq designed the study and protocol. J. Achar, M.M. Assao Neino, A.K.J. Maug, D. Bang, S. Brode, E. Casas, F. Conradie, G. Dravniece, P. du Cros, C. Kuaban, A. Miller, B. Myrzaliev, G.B. Migliori, M. Makhmudova, J. Noeske, N. Ndjeka, A. Piubello, N. Parpieva, M.B. Souleymane, R. Singla, V. Schwoebel, W. Sikhondze and A. Trébucq contributed data to the meta-analysis. S. Abidi, F. Ahmad Khan, A. Benedetti, J.R. Campbell, P.Z. Li, Z. Lan, D. Menzies and B.J. Zhang did the data analysis. F. Ahmad Khan wrote the initial draft of the manuscript, and all authors provided critical input and revisions to the draft manuscripts, and approved the final manuscript.

  • Conflict of interest: S. Abidi has nothing to disclose.

  • Conflict of interest: J. Achar has nothing to disclose.

  • Conflict of interest: M.M. Assao Neino has nothing to disclose.

  • Conflict of interest: D. Bang has nothing to disclose.

  • Conflict of interest: A. Benedetti has nothing to disclose.

  • Conflict of interest: S. Brode reports grants from Insmed and the Canadian Institutes for Health Research, personal fees for educational presentations from Boehringer Ingelheim and AstraZeneca, outside the submitted work.

  • Conflict of interest: J.R. Campbell has nothing to disclose.

  • Conflict of interest: E. Casas has nothing to disclose.

  • Conflict of interest: F. Conradie has nothing to disclose.

  • Conflict of interest: G. Dravniece has nothing to disclose.

  • Conflict of interest: P. du Cros reports he was previously a member of the steering committee and protocol writing committee for the PRACTECAL randomised controlled trial of three novel 6-month MDR-TB regimens; and has undertaken a paid consultancy between TB Alliance and Burnet Institute to investigate applicability of the TB-Nix regimen (a novel short MDR-TB regimen) to Papua New Guinea.

  • Conflict of interest: D. Falzon has nothing to disclose.

  • Conflict of interest: E. Jaramillo has nothing to disclose.

  • Conflict of interest: C. Kuaban has nothing to disclose.

  • Conflict of interest: Z. Lan has nothing to disclose.

  • Conflict of interest: C. Lange reports personal fees for lectures from Chiesi, Gilead, Janssen, Lucane, Novartis, Oxoid, Berlin-Chemie and Thermo Fisher, outside the submitted work.

  • Conflict of interest: P.Z. Li has nothing to disclose.

  • Conflict of interest: M. Makhmudova has nothing to disclose.

  • Conflict of interest: A.K.J. Maug has nothing to disclose.

  • Conflict of interest: D. Menzies has nothing to disclose.

  • Conflict of interest: G.B. Migliori has nothing to disclose.

  • Conflict of interest: A. Miller reports that The Eli Lilly Foundation MDR-TB Partnership provided partial salary support in 2015–2016 through a grant to Salmaan Keshavjee, Harvard Medical School, although none of the work in the current paper or analysis was supported through that mechanism; the grant also paid for travel to a meeting in July of 2016.

  • Conflict of interest: B. Myrzaliev has nothing to disclose.

  • Conflict of interest: N. Ndjeka has nothing to disclose.

  • Conflict of interest: J. Noeske has nothing to disclose.

  • Conflict of interest: N. Parpieva has nothing to disclose.

  • Conflict of interest: A. Piubello has nothing to disclose.

  • Conflict of interest: V. Schwoebel has nothing to disclose.

  • Conflict of interest: W. Sikhondze has nothing to disclose.

  • Conflict of interest: R. Singla has nothing to disclose.

  • Conflict of interest: M.B. Souleymane has nothing to disclose.

  • Conflict of interest: A. Trébucq has nothing to disclose.

  • Conflict of interest: A. Van Deun has nothing to disclose.

  • Conflict of interest: K. Viney has nothing to disclose.

  • Conflict of interest: K. Weyer has nothing to disclose.

  • Conflict of interest: B.J. Zhang has nothing to disclose.

  • Conflict of interest: F. Ahmad Khan reports grants from the World Health Organization during the conduct of the study.

  • Support statement: This work was supported by the World Health Organization. Funding information for this article has been deposited with the Crossref Funder Registry.

  • Received July 23, 2019.
  • Accepted December 4, 2019.
  • The content of this work is copyright of the authors or their employers. Design and branding are copyright ©ERS 2020.
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Standardised shorter regimens versus individualised longer regimens for rifampin- or multidrug-resistant tuberculosis
Syed Abidi, Jay Achar, Mourtala Mohamed Assao Neino, Didi Bang, Andrea Benedetti, Sarah Brode, Jonathon R. Campbell, Esther C. Casas, Francesca Conradie, Gunta Dravniece, Philipp du Cros, Dennis Falzon, Ernesto Jaramillo, Christopher Kuaban, Zhiyi Lan, Christoph Lange, Pei Zhi Li, Mavluda Makhmudova, Aung Kya Jai Maug, Dick Menzies, Giovanni Battista Migliori, Ann Miller, Bakyt Myrzaliev, Norbert Ndjeka, Jürgen Noeske, Nargiza Parpieva, Alberto Piubello, Valérie Schwoebel, Welile Sikhondze, Rupak Singla, Mahamadou Bassirou Souleymane, Arnaud Trébucq, Armand Van Deun, Kerri Viney, Karin Weyer, Betty Jingxuan Zhang, Faiz Ahmad Khan
European Respiratory Journal Mar 2020, 55 (3) 1901467; DOI: 10.1183/13993003.01467-2019

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Standardised shorter regimens versus individualised longer regimens for rifampin- or multidrug-resistant tuberculosis
Syed Abidi, Jay Achar, Mourtala Mohamed Assao Neino, Didi Bang, Andrea Benedetti, Sarah Brode, Jonathon R. Campbell, Esther C. Casas, Francesca Conradie, Gunta Dravniece, Philipp du Cros, Dennis Falzon, Ernesto Jaramillo, Christopher Kuaban, Zhiyi Lan, Christoph Lange, Pei Zhi Li, Mavluda Makhmudova, Aung Kya Jai Maug, Dick Menzies, Giovanni Battista Migliori, Ann Miller, Bakyt Myrzaliev, Norbert Ndjeka, Jürgen Noeske, Nargiza Parpieva, Alberto Piubello, Valérie Schwoebel, Welile Sikhondze, Rupak Singla, Mahamadou Bassirou Souleymane, Arnaud Trébucq, Armand Van Deun, Kerri Viney, Karin Weyer, Betty Jingxuan Zhang, Faiz Ahmad Khan
European Respiratory Journal Mar 2020, 55 (3) 1901467; DOI: 10.1183/13993003.01467-2019
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