Table 3.
Electrocardiographic Findings
| Finding | All Patients (n = 183) | BDQ Only (n = 4) | BDQ and CFZ (n = 179) | BDQ and LPV/r (With or Without CFZ) (n = 23) | BDQ Without LPV/r (n = 160) |
|---|---|---|---|---|---|
| QTcF, mean (SD), ms | |||||
| Baseline | 404.6 (22.2) | 398.8 (21.1) | 404.7 (22.2) | 405.1 (20.3) | 404.5 (22.5) |
| mo 1 | 418.7 (24.3) | 403.5 (20.2) | 419.1 (24.4) | 425.5 (35) | 417.8 (22.5) |
| mo 2 | 421.2 (25.4) | 429.2 (13.6) | 421.0 (25.6) | 411.9 (16.8) | 422.3 (26.1) |
| mo 6 | 427.6 (22.1) | … | 427.6 (22.1) | 427.5 (22.3) | 427.6 (22.2) |
| Maximum QTcF, mean (SD) (all participants) | 434.4 (24.5) | 416.7 (27.3) | 434.8 (24.4) | 437.1 (31.0) | 434.0 (23.5) |
| Participants receiving MFX before BDQ initiation, no. | 117 | 2 | 115 | 13 | 104 |
| Participants who stopped MFX before starting BDQ, no. (%) | 96 (82) | 2 (100) | 94 (82) | 11 (85) | 85 (82) |
| Duration of MFX washout before baseline ECG, median (IQR), d | 1 (0–2) | 1 (1–69) | 1 (0–2) | 1 (0–2) | 1 (0–2) |
| QTcF increase from baseline to mo 6, mean (SD) | 23.7 (22.7) | … | 23.7 (22.7) | 26.4 (22.2) | 23.4 (22.9) |
| Participants, no. (%) | |||||
| With mean QTcF increase >60 ms | 8 (4.4) | 0 (0) | 8 (4.5) | 2 (8.7) | 6 (3.8) |
| With mean QTcF increase >30 ms | 61 (33.3) | 1 (25) | 60 (33.5) | 6 (26.1) | 55 (34.4) |
| With QTcF >500 ms | 4 (2) | 0 (0) | 4 (2.2) | 2 (8.7) | 2 (1.3) |
| With QTcF >450 ms | 42 (23) | 0 (0) | 42 (23.5) | 5 (21.7) | 37 (23.1) |
Abbreviations: BDQ, bedaquiline; CFZ, clofazimine; ECG, electrocardiogram; IQR, interquartile range; LPV/r, lopinavir-ritonavir; MFX, moxifloxacin; QTcF, QT interval corrected by the Fridericia method; SD, standard deviation.