Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort

S. Koirala; S. Borisov; E. Danila; A. Mariandyshev; B. Shrestha; N. Lukhele; M. Dalcolmo; S. R. Shakya; S. Miliauskas; L. Kuksa; S. Manga; A. Aleksa; J. T. Denholm; H. B. Khadka; A. Skrahina; S. Diktanas; M. Ferrarese; J. Bruchfeld; A. Koleva; A. Piubello; G. S. Koirala; Z. F. Udwadia; D. J. Palmero; M. Munoz-Torrico; R. GC; G. Gualano; V. I. Grecu; I. Motta; A. Papavasileiou; Y. Li; W. Hoefsloot; H. Kunst; J. Mazza-Stalder; M. C. Payen; O. W. Akkerman; E. Bernal; V. Manfrin; A. Matteelli; H. Mustafa Hamdan; M. Nieto Marcos; J. Cadiñanos Loidi; J. J. Cebrian Gallardo; R. Duarte; N. Escobar Salinas; R. Gomez Rosso; R. Laniado-Laborín; E. Martínez Robles; S. Quirós Fernandez; A. Rendon; A. Šmite; Giovanni B. Migliori

doi:10.1016/j.pulmoe.2021.02.006

Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort

S. Koirala, S. Borisov, E. Danila, A. Mariandyshev, B. Shrestha, N. Lukhele, M. Dalcolmo, S. R. Shakya, S. Miliauskas, L. Kuksa, S. Manga, A. Aleksa, J. T. Denholm, H. B. Khadka, A. Skrahina, S. Diktanas, M. Ferrarese, J. Bruchfeld, A. Koleva, A. PiubelloG. S. Koirala, Z. F. Udwadia, D. J. Palmero, M. Munoz-Torrico, R. GC, G. Gualano, V. I. Grecu, I. Motta, A. Papavasileiou, Y. Li, W. Hoefsloot, H. Kunst, J. Mazza-Stalder, M. C. Payen, O. W. Akkerman, E. Bernal, V. Manfrin, A. Matteelli, H. Mustafa Hamdan, M. Nieto Marcos, J. Cadiñanos Loidi, J. J. Cebrian Gallardo, R. Duarte, N. Escobar Salinas, R. Gomez Rosso, R. Laniado-Laborín, E. Martínez Robles, S. Quirós Fernandez, A. Rendon, A. Šmite, Giovanni B. Migliori

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Abstract

The World Health Organization (WHO) recommends countries introduce new anti-TB drugs in the treatment of multidrug-resistant tuberculosis. The aim of the study is to prospectively evaluate the effectiveness of bedaquiline (and/or delamanid)- containing regimens in a large cohort of consecutive TB patients treated globally. This observational, prospective study is based on data collected and provided by Global Tuberculosis Network (GTN) centres and analysed twice a year. All consecutive patients (including children/adolescents) treated with bedaquiline and/or delamanid were enrolled, and managed according to WHO and national guidelines. Overall, 52 centres from 29 countries/regions in all continents reported 883 patients as of January 31st 2021, 24/29 countries/regions providing data on 100% of their consecutive patients (10–80% in the remaining 5 countries). The drug-resistance pattern of the patients was severe (>30% with extensively drug-resistant -TB; median number of resistant drugs 5 (3−7) in the overall cohort and 6 (4−8) among patients with a final outcome). For the patients with a final outcome (477/883, 54.0%) the median (IQR) number of months of anti-TB treatment was 18 (13−23) (in days 553 (385–678)). The proportion of patients achieving sputum smear and culture conversion ranged from 93.4% and 92.8% respectively (whole cohort) to 89.3% and 88.8% respectively (patients with a final outcome), a median (IQR) time to sputum smear and culture conversion of 58 (30−90) days for the whole cohort and 60 (30−100) for patients with a final outcome and, respectively, of 55 (30−90) and 60 (30−90) days for culture conversion. Of 383 patients treated with bedaquiline but not delamanid, 284 (74.2%) achieved treatment success, while 25 (6.5%) died, 11 (2.9%) failed and 63 (16.5%) were lost to follow-up.

Original language	English
Pages (from-to)	403-412
Number of pages	10
Journal	Pulmonology
Volume	27
Issue number	5
DOIs	https://doi.org/10.1016/j.pulmoe.2021.02.006
Publication status	Published - 1 Sept 2021
Externally published	Yes

Keywords*

Bedaquiline
Delamanid
MDR-TB
Prevention of TB sequelae
Treatment outcomes
Tuberculosis

Field of Science*

3.2 Clinical medicine
3.3 Health sciences

Publication Type*

1.1. Scientific article indexed in Web of Science and/or Scopus database

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.pulmoe.2021.02.006

Outcome of treatment of MDR-TBFinal published version, 776 KBLicence: CC BY-NC-ND

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Koirala, S., Borisov, S., Danila, E., Mariandyshev, A., Shrestha, B., Lukhele, N., Dalcolmo, M., Shakya, S. R., Miliauskas, S., Kuksa, L., Manga, S., Aleksa, A., Denholm, J. T., Khadka, H. B., Skrahina, A., Diktanas, S., Ferrarese, M., Bruchfeld, J., Koleva, A., ... Migliori, G. B. (2021). Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort. Pulmonology, 27(5), 403-412. https://doi.org/10.1016/j.pulmoe.2021.02.006

@article{72ae62efe16a4642aac71e3e03a8ed2c,

title = "Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort",

abstract = "The World Health Organization (WHO) recommends countries introduce new anti-TB drugs in the treatment of multidrug-resistant tuberculosis. The aim of the study is to prospectively evaluate the effectiveness of bedaquiline (and/or delamanid)- containing regimens in a large cohort of consecutive TB patients treated globally. This observational, prospective study is based on data collected and provided by Global Tuberculosis Network (GTN) centres and analysed twice a year. All consecutive patients (including children/adolescents) treated with bedaquiline and/or delamanid were enrolled, and managed according to WHO and national guidelines. Overall, 52 centres from 29 countries/regions in all continents reported 883 patients as of January 31st 2021, 24/29 countries/regions providing data on 100% of their consecutive patients (10–80% in the remaining 5 countries). The drug-resistance pattern of the patients was severe (>30% with extensively drug-resistant -TB; median number of resistant drugs 5 (3−7) in the overall cohort and 6 (4−8) among patients with a final outcome). For the patients with a final outcome (477/883, 54.0%) the median (IQR) number of months of anti-TB treatment was 18 (13−23) (in days 553 (385–678)). The proportion of patients achieving sputum smear and culture conversion ranged from 93.4% and 92.8% respectively (whole cohort) to 89.3% and 88.8% respectively (patients with a final outcome), a median (IQR) time to sputum smear and culture conversion of 58 (30−90) days for the whole cohort and 60 (30−100) for patients with a final outcome and, respectively, of 55 (30−90) and 60 (30−90) days for culture conversion. Of 383 patients treated with bedaquiline but not delamanid, 284 (74.2%) achieved treatment success, while 25 (6.5%) died, 11 (2.9%) failed and 63 (16.5%) were lost to follow-up.",

keywords = "Bedaquiline, Delamanid, MDR-TB, Prevention of TB sequelae, Treatment outcomes, Tuberculosis",

author = "S. Koirala and S. Borisov and E. Danila and A. Mariandyshev and B. Shrestha and N. Lukhele and M. Dalcolmo and Shakya, {S. R.} and S. Miliauskas and L. Kuksa and S. Manga and A. Aleksa and Denholm, {J. T.} and Khadka, {H. B.} and A. Skrahina and S. Diktanas and M. Ferrarese and J. Bruchfeld and A. Koleva and A. Piubello and Koirala, {G. S.} and Udwadia, {Z. F.} and Palmero, {D. J.} and M. Munoz-Torrico and R. GC and G. Gualano and Grecu, {V. I.} and I. Motta and A. Papavasileiou and Y. Li and W. Hoefsloot and H. Kunst and J. Mazza-Stalder and Payen, {M. C.} and Akkerman, {O. W.} and E. Bernal and V. Manfrin and A. Matteelli and {Mustafa Hamdan}, H. and {Nieto Marcos}, M. and {Cadi{\~n}anos Loidi}, J. and {Cebrian Gallardo}, {J. J.} and R. Duarte and {Escobar Salinas}, N. and {Gomez Rosso}, R. and R. Laniado-Labor{\'i}n and {Mart{\'i}nez Robles}, E. and {Quir{\'o}s Fernandez}, S. and A. Rendon and A. {\v S}mite and Migliori, {Giovanni B.}",

note = "Funding Information: The project is supported by the Global Tuberculosis Network (GTN; Committees on TB Treatment, Clinical trials and Global TB Consilium) and was part of the European Respiratory Society Latin American project in collaboration with ALAT (Asociaci?n Latino Americana de Torax - Latino American Thoracic Association) and SBPT (Brazilian Society of Pulmonology and Tuberculosis). This article belongs to the scientific activities of the WHO Collaborating Centre for Tuberculosis and Lung Diseases, Tradate, ITA-80, 2017-2020- GBM/RC/LDA. The Authors wish to thank Dr. Algirdas Gauronskis, Dr.Vita Globyt? (Clinic of Tuberculosis and Pulmonology, Republican ?iauliai county hospital, ?iauliai, Lithuania), Dr. Antanas Strazdas (Department of Tuberculosis, Alytus County Tuberculosis Hospital, Alytus, Lithuania), Dr. Paola Castellotti (Regional TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy), Ms. Samriddhi Karki (Kalimati Chest Hospital/ GENETUP NATA, Nepal), Dr Andrea Calcagno, Alberto Gaviraghi and Francesca Alladio (Department of Medical Science, Unit of Infectious Diseases, University of Torino, Italy) for their contribution. Publisher Copyright: {\textcopyright} 2021 Sociedade Portuguesa de Pneumologia",

year = "2021",

month = sep,

day = "1",

doi = "10.1016/j.pulmoe.2021.02.006",

language = "English",

volume = "27",

pages = "403--412",

journal = "Pulmonology",

issn = "2531-0429",

publisher = "Elsevier Espana",

number = "5",

}

Koirala, S, Borisov, S, Danila, E, Mariandyshev, A, Shrestha, B, Lukhele, N, Dalcolmo, M, Shakya, SR, Miliauskas, S, Kuksa, L, Manga, S, Aleksa, A, Denholm, JT, Khadka, HB, Skrahina, A, Diktanas, S, Ferrarese, M, Bruchfeld, J, Koleva, A, Piubello, A, Koirala, GS, Udwadia, ZF, Palmero, DJ, Munoz-Torrico, M, GC, R, Gualano, G, Grecu, VI, Motta, I, Papavasileiou, A, Li, Y, Hoefsloot, W, Kunst, H, Mazza-Stalder, J, Payen, MC, Akkerman, OW, Bernal, E, Manfrin, V, Matteelli, A, Mustafa Hamdan, H, Nieto Marcos, M, Cadiñanos Loidi, J, Cebrian Gallardo, JJ, Duarte, R, Escobar Salinas, N, Gomez Rosso, R, Laniado-Laborín, R, Martínez Robles, E, Quirós Fernandez, S, Rendon, A, Šmite, A & Migliori, GB 2021, 'Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort', Pulmonology, vol. 27, no. 5, pp. 403-412. https://doi.org/10.1016/j.pulmoe.2021.02.006

TY - JOUR

T1 - Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid

T2 - Results from a large global cohort

AU - Koirala, S.

AU - Borisov, S.

AU - Danila, E.

AU - Mariandyshev, A.

AU - Shrestha, B.

AU - Lukhele, N.

AU - Dalcolmo, M.

AU - Shakya, S. R.

AU - Miliauskas, S.

AU - Kuksa, L.

AU - Manga, S.

AU - Aleksa, A.

AU - Denholm, J. T.

AU - Khadka, H. B.

AU - Skrahina, A.

AU - Diktanas, S.

AU - Ferrarese, M.

AU - Bruchfeld, J.

AU - Koleva, A.

AU - Piubello, A.

AU - Koirala, G. S.

AU - Udwadia, Z. F.

AU - Palmero, D. J.

AU - Munoz-Torrico, M.

AU - GC, R.

AU - Gualano, G.

AU - Grecu, V. I.

AU - Motta, I.

AU - Papavasileiou, A.

AU - Li, Y.

AU - Hoefsloot, W.

AU - Kunst, H.

AU - Mazza-Stalder, J.

AU - Payen, M. C.

AU - Akkerman, O. W.

AU - Bernal, E.

AU - Manfrin, V.

AU - Matteelli, A.

AU - Mustafa Hamdan, H.

AU - Nieto Marcos, M.

AU - Cadiñanos Loidi, J.

AU - Cebrian Gallardo, J. J.

AU - Duarte, R.

AU - Escobar Salinas, N.

AU - Gomez Rosso, R.

AU - Laniado-Laborín, R.

AU - Martínez Robles, E.

AU - Quirós Fernandez, S.

AU - Rendon, A.

AU - Šmite, A.

AU - Migliori, Giovanni B.

N1 - Funding Information: The project is supported by the Global Tuberculosis Network (GTN; Committees on TB Treatment, Clinical trials and Global TB Consilium) and was part of the European Respiratory Society Latin American project in collaboration with ALAT (Asociaci?n Latino Americana de Torax - Latino American Thoracic Association) and SBPT (Brazilian Society of Pulmonology and Tuberculosis). This article belongs to the scientific activities of the WHO Collaborating Centre for Tuberculosis and Lung Diseases, Tradate, ITA-80, 2017-2020- GBM/RC/LDA. The Authors wish to thank Dr. Algirdas Gauronskis, Dr.Vita Globyt? (Clinic of Tuberculosis and Pulmonology, Republican ?iauliai county hospital, ?iauliai, Lithuania), Dr. Antanas Strazdas (Department of Tuberculosis, Alytus County Tuberculosis Hospital, Alytus, Lithuania), Dr. Paola Castellotti (Regional TB Reference Centre, Villa Marelli Institute, Niguarda Hospital, Milan, Italy), Ms. Samriddhi Karki (Kalimati Chest Hospital/ GENETUP NATA, Nepal), Dr Andrea Calcagno, Alberto Gaviraghi and Francesca Alladio (Department of Medical Science, Unit of Infectious Diseases, University of Torino, Italy) for their contribution. Publisher Copyright: © 2021 Sociedade Portuguesa de Pneumologia

PY - 2021/9/1

Y1 - 2021/9/1

N2 - The World Health Organization (WHO) recommends countries introduce new anti-TB drugs in the treatment of multidrug-resistant tuberculosis. The aim of the study is to prospectively evaluate the effectiveness of bedaquiline (and/or delamanid)- containing regimens in a large cohort of consecutive TB patients treated globally. This observational, prospective study is based on data collected and provided by Global Tuberculosis Network (GTN) centres and analysed twice a year. All consecutive patients (including children/adolescents) treated with bedaquiline and/or delamanid were enrolled, and managed according to WHO and national guidelines. Overall, 52 centres from 29 countries/regions in all continents reported 883 patients as of January 31st 2021, 24/29 countries/regions providing data on 100% of their consecutive patients (10–80% in the remaining 5 countries). The drug-resistance pattern of the patients was severe (>30% with extensively drug-resistant -TB; median number of resistant drugs 5 (3−7) in the overall cohort and 6 (4−8) among patients with a final outcome). For the patients with a final outcome (477/883, 54.0%) the median (IQR) number of months of anti-TB treatment was 18 (13−23) (in days 553 (385–678)). The proportion of patients achieving sputum smear and culture conversion ranged from 93.4% and 92.8% respectively (whole cohort) to 89.3% and 88.8% respectively (patients with a final outcome), a median (IQR) time to sputum smear and culture conversion of 58 (30−90) days for the whole cohort and 60 (30−100) for patients with a final outcome and, respectively, of 55 (30−90) and 60 (30−90) days for culture conversion. Of 383 patients treated with bedaquiline but not delamanid, 284 (74.2%) achieved treatment success, while 25 (6.5%) died, 11 (2.9%) failed and 63 (16.5%) were lost to follow-up.

AB - The World Health Organization (WHO) recommends countries introduce new anti-TB drugs in the treatment of multidrug-resistant tuberculosis. The aim of the study is to prospectively evaluate the effectiveness of bedaquiline (and/or delamanid)- containing regimens in a large cohort of consecutive TB patients treated globally. This observational, prospective study is based on data collected and provided by Global Tuberculosis Network (GTN) centres and analysed twice a year. All consecutive patients (including children/adolescents) treated with bedaquiline and/or delamanid were enrolled, and managed according to WHO and national guidelines. Overall, 52 centres from 29 countries/regions in all continents reported 883 patients as of January 31st 2021, 24/29 countries/regions providing data on 100% of their consecutive patients (10–80% in the remaining 5 countries). The drug-resistance pattern of the patients was severe (>30% with extensively drug-resistant -TB; median number of resistant drugs 5 (3−7) in the overall cohort and 6 (4−8) among patients with a final outcome). For the patients with a final outcome (477/883, 54.0%) the median (IQR) number of months of anti-TB treatment was 18 (13−23) (in days 553 (385–678)). The proportion of patients achieving sputum smear and culture conversion ranged from 93.4% and 92.8% respectively (whole cohort) to 89.3% and 88.8% respectively (patients with a final outcome), a median (IQR) time to sputum smear and culture conversion of 58 (30−90) days for the whole cohort and 60 (30−100) for patients with a final outcome and, respectively, of 55 (30−90) and 60 (30−90) days for culture conversion. Of 383 patients treated with bedaquiline but not delamanid, 284 (74.2%) achieved treatment success, while 25 (6.5%) died, 11 (2.9%) failed and 63 (16.5%) were lost to follow-up.

KW - Bedaquiline

KW - Delamanid

KW - MDR-TB

KW - Prevention of TB sequelae

KW - Treatment outcomes

KW - Tuberculosis

UR - http://www.scopus.com/inward/record.url?scp=85103421945&partnerID=8YFLogxK

U2 - 10.1016/j.pulmoe.2021.02.006

DO - 10.1016/j.pulmoe.2021.02.006

M3 - Article

C2 - 33753021

AN - SCOPUS:85103421945

SN - 2531-0429

VL - 27

SP - 403

EP - 412

JO - Pulmonology

JF - Pulmonology

IS - 5

ER -

Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort

Abstract

Keywords*

Field of Science*

Publication Type*

UN SDGs

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