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

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 PneumologiaThe 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.Peer reviewe