High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen.

South African patients with rifampicin-resistant tuberculosis (TB) and resistance to fluoroquinolones and/or injectable drugs (extensively drug-resistant (XDR) and preXDR-TB) were granted access to bedaquiline through a clinical access programme with strict inclusion and exclusion criteria.PreXDR-TB and XDR-TB patients were treated with 24 weeks of bedaquiline within an optimised, individualised background regimen that could include levofloxacin, linezolid and clofazimine as needed. 200 patients were enrolled: 87 (43.9%) had XDR-TB, 99 (49.3%) were female and the median age was 34 years (interquartile range (IQR) 27-42). 134 (67.0%) were living with HIV; the median CD4 ⁺ count was 281 cells·μL ^-1 (IQR 130-467) and all were on antiretroviral therapy.16 out of 200 patients (8.0%) did not complete 6 months of bedaquiline: eight were lost to follow-up, six died, one stopped owing to side effects and one was diagnosed with drug-sensitive TB. 146 out of 200 patients (73.0%) had favourable outcomes: 139 (69.5%) were cured and seven (3.5%) completed treatment. 25 patients (12.5%) died, 20 (10.0%) were lost from treatment and nine (4.5%) had treatment failure. 22 adverse events were attributed to bedaquiline, including a QT interval corrected using the Fridericia formula (QTcF) >500 ms (n=5), QTcF increase >50 ms from baseline (n=11) and paroxysmal atrial flutter (n=1).Bedaquiline added to an optimised background regimen was associated with a high rate of successful treatment outcomes for this preXDR-TB and XDR-TB cohort.
Competing Interests: Conflict of interest: N. Ndjeka reports non-financial support (donation of bedaquiline) from Janssen Pharmaceutica, during the conduct of the study; and Janssen Pharmaceutica provided support to the SA TB Programme: funding for training, provision of ECG machines and hearing tests machines. N Ndjeka is an official within the South African Department of Health; his responsibilities include recommending guidelines for drug-resistant TB treatment. Conflict of interest: K. Schnippel has nothing to disclose. Conflict of interest: I. Master has nothing to disclose. Conflict of interest: G. Meintjes has nothing to disclose. Conflict of interest: G. Maartens has nothing to disclose. Conflict of interest: R. Romero has nothing to disclose. Conflict of interest: X. Padanilam has nothing to disclose. Conflict of interest: M. Enwerem has nothing to disclose. Conflict of interest: S. Chotoo has nothing to disclose. Conflict of interest: N. Singh has nothing to disclose. Conflict of interest: J. Hughes has nothing to disclose. Conflict of interest: E. Variava has nothing to disclose. Conflict of interest: H. Ferreira has nothing to disclose. Conflict of interest: J. te Riele has nothing to disclose. Conflict of interest: N. Ismail has nothing to disclose. Conflict of interest: E. Mohr has nothing to disclose. Conflict of interest: N. Bantubani has nothing to disclose. Conflict of interest: F. Conradie reports sponsorship for travel and registration for conferences from Janssen Pharmacuetica, outside the submitted work.
(Copyright ©ERS 2018.)