RT Journal Article
SR Electronic
T1 High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1801528
DO 10.1183/13993003.01528-2018
A1 Norbert Ndjeka
A1 Kathryn Schnippel
A1 Iqbal Master
A1 Graeme Meintjes
A1 Gary Maartens
A1 Rodolfo Romero
A1 Xavier Padanilam
A1 Martin Enwerem
A1 Sunitha Chotoo
A1 Nalini Singh
A1 Jennifer Hughes
A1 Ebrahim Variava
A1 Hannetjie Ferreira
A1 Julian te Riele
A1 Nazir Ismail
A1 Erika Mohr
A1 Nonkqubela Bantubani
A1 Francesca Conradie
YR 2018
UL http://erj.ersjournals.com/content/early/2018/10/11/13993003.01528-2018.abstract
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.