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.

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

Spanevello A.;Visca D.;
2021-01-01

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.
2021
Bedaquiline; Delamanid; MDR-TB; Prevention of TB sequelae; Treatment outcomes; Tuberculosis
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.; Piubello, A.; Koirala, G. S.; Udwadia, Z. F.; Palmero, D. J.; Munoz-Torrico, M.; Gc, R.; Gualano, G.; Grecu, V. I.; Motta, I.; Papavasileiou, A.; Li, Y.; Hoefsloot, W.; Kunst, H.; Mazza-Stalder, J.; Payen, M. -C.; Akkerman, O. W.; Bernal, E.; Manfrin, V.; Matteelli, A.; Mustafa Hamdan, H.; Nieto Marcos, M.; Cadinanos Loidi, J.; Cebrian Gallardo, J. J.; Duarte, R.; Escobar Salinas, N.; Gomez Rosso, R.; Laniado-Laborin, R.; Martinez Robles, E.; Quiros Fernandez, S.; Rendon, A.; Solovic, I.; Tadolini, M.; Viggiani, P.; Belilovski, E.; Boeree, M. J.; Cai, Q.; Davidaviciene, E.; Forsman, L. D.; De Los Rios, J.; Draksiene, J.; Duga, A.; Elamin, S. E.; Filippov, A.; Garcia, A.; Gaudiesiute, I.; Gavazova, B.; Gayoso, R.; Gruslys, V.; Jonsson, J.; Khimova, E.; Madonsela, G.; Magis-Escurra, C.; Marchese, V.; Matei, M.; Moschos, C.; Nakceriene, B.; Nicod, L.; Palmieri, F.; Pontarelli, A.; Smite, A.; Souleymane, M. B.; Vescovo, M.; Zablockis, R.; Zhurkin, D.; Alffenaar, J. -W.; Caminero, J. A.; Codecasa, L. R.; Garcia-Garcia, J. -M.; Esposito, S.; Saderi, L.; Spanevello, A.; Visca, D.; Tiberi, S.; Pontali, E.; Centis, R.; D'Ambrosio, L.; van den Boom, M.; Sotgiu, G.; Migliori, G. B.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11383/2113701
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