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Observational Study
. 2021 Sep-Oct;27(5):403-412.
doi: 10.1016/j.pulmoe.2021.02.006. Epub 2021 Mar 19.

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

S Koirala  1 , S Borisov  2 , E Danila  3 , A Mariandyshev  4 , B Shrestha  5 , N Lukhele  6 , M Dalcolmo  7 , S R Shakya  8 , S Miliauskas  9 , L Kuksa  10 , S Manga  11 , A Aleksa  12 , J T Denholm  13 , H B Khadka  14 , A Skrahina  15 , S Diktanas  16 , M Ferrarese  17 , J Bruchfeld  18 , A Koleva  19 , A Piubello  20 , G S Koirala  21 , Z F Udwadia  22 , D J Palmero  23 , M Munoz-Torrico  24 , R Gc  25 , G Gualano  26 , V I Grecu  27 , I Motta  28 , A Papavasileiou  29 , Y Li  30 , W Hoefsloot  31 , H Kunst  32 , J Mazza-Stalder  33 , M-C Payen  34 , O W Akkerman  35 , E Bernal  36 , V Manfrin  37 , A Matteelli  38 , H Mustafa Hamdan  39 , M Nieto Marcos  40 , J Cadiñanos Loidi  41 , J J Cebrian Gallardo  42 , R Duarte  43 , N Escobar Salinas  44 , R Gomez Rosso  45 , R Laniado-Laborín  46 , E Martínez Robles  47 , S Quirós Fernandez  48 , A Rendon  49 , I Solovic  50 , M Tadolini  51 , P Viggiani  52 , E Belilovski  2 , M J Boeree  31 , Q Cai  53 , E Davidavičienė  54 , L D Forsman  18 , J De Los Rios  55 , J Drakšienė  16 , A Duga  56 , S E Elamin  39 , A Filippov  2 , A Garcia  23 , I Gaudiesiute  9 , B Gavazova  57 , R Gayoso  7 , V Gruslys  3 , J Jonsson  58 , E Khimova  4 , G Madonsela  59 , C Magis-Escurra  31 , V Marchese  38 , M Matei  60 , C Moschos  29 , B Nakčerienė  54 , L Nicod  33 , F Palmieri  26 , A Pontarelli  61 , A Šmite  10 , M B Souleymane  20 , M Vescovo  23 , R Zablockis  3 , D Zhurkin  15 , J-W Alffenaar  62 , J A Caminero  63 , L R Codecasa  17 , J-M García-García  64 , S Esposito  65 , L Saderi  66 , A Spanevello  67 , D Visca  67 , S Tiberi  68 , E Pontali  69 , R Centis  70 , L D'Ambrosio  71 , M van den Boom  72 , G Sotgiu  66 , G B Migliori  73
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Free article
Observational Study

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

S Koirala et al. Pulmonology. 2021 Sep-Oct.
Free article

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.

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