PT - JOURNAL ARTICLE AU - Norbert Ndjeka AU - Kathryn Schnippel AU - Iqbal Master AU - Graeme Meintjes AU - Gary Maartens AU - Rodolfo Romero AU - Xavier Padanilam AU - Martin Enwerem AU - Sunitha Chotoo AU - Nalini Singh AU - Jennifer Hughes AU - Ebrahim Variava AU - Hannetjie Ferreira AU - Julian te Riele AU - Nazir Ismail AU - Erika Mohr AU - Nonkqubela Bantubani AU - Francesca Conradie TI - High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen AID - 10.1183/13993003.01528-2018 DP - 2018 Jan 01 TA - European Respiratory Journal PG - 1801528 4099 - http://erj.ersjournals.com/content/early/2018/10/11/13993003.01528-2018.short 4100 - http://erj.ersjournals.com/content/early/2018/10/11/13993003.01528-2018.full AB - Background: South African patients with rifampicin-resistant tuberculosis and resistance to fluoroquinolones and/or injectables (pre/XDR-TB) were granted access to bedaquiline through a Clinical Access Programme with strict inclusion and exclusion criteria.Methods: Pre/XDR-TB and XDR-TB patients were treated with 24 weeks bedaquiline within an optimised, individualised background regimen that could include levofloxacin, linezolid and clofazimine as needed.Results: 200 patients were enrolled: 87 (43.9%) with XDR-TB, 99 (49.3%) were female, median age 34 years (IQR 27, 42). 134 (67.0%) were living with HIV; median CD4+ 281 (IQR 130; 467) and all on antiretroviral therapy.16/200 patients (8.0%) did not complete 6 months of bedaquiline of which 8 were lost to follow up, 6 died, 1 stopped for side effects and 1 patient was diagnosed with drug-sensitive TB.146/200 (73.0%) patients had favourable outcomes: 139/200 were cured (69.5%) and 7 completed treatment (3.5%). 25 died (12.5%), were lost from treatment (10.0%), 9 had treatment failure (4.5%).22 adverse events were attributed to bedaquiline: including QTcF >500 ms (n=5), QTcF increase >50 ms from baseline (n=11), paroxysmal atrial flutter (n=1).Conclusion: Bedaquiline added to an optimised background regimen was associated with a high rate of successful treatment outcomes for this MDR-TB and XDR-TB cohort.FootnotesThis manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Please open or download the PDF to view this article.Conflict of interest: Dr. Schnippel has nothing to disclose.Conflict of interest: Dr. Master has nothing to disclose.Conflict of interest: Dr. Meintjes has nothing to disclose.Conflict of interest: Dr. Maartens has nothing to disclose.Conflict of interest: Dr. PADANILAM has nothing to disclose.Conflict of interest: Dr. Enwerem has nothing to disclose.Conflict of interest: Dr. Chotoo has nothing to disclose.Conflict of interest: Dr. Singh has nothing to disclose.Conflict of interest: Dr. Hughes has nothing to disclose.Conflict of interest: Dr. Variava has nothing to disclose.Conflict of interest: Dr. Ferreira has nothing to disclose.Conflict of interest: Dr. te Riele has nothing to disclose.Conflict of interest: Mrs. Mohr has nothing to disclose.Conflict of interest: Dr. Bantubani has nothing to disclose.Conflict of interest: Dr. Ismail has nothing to disclose.Conflict of interest: Dr. Conradie reports other from Janssen Pharmacuetica, outside the submitted work.Conflict of interest: Dr. Romero Leyet has nothing to disclose.Conflict of interest: Dr. Ndjeka reports non-financial support from Janssen Pharmaceutica, during the conduct of the study; and Janssen Pharmaceutica has provided support to the SA TB Programme: funding for training, provision of ECG machines and hearing tests machines.