Table 3.
Factors Associated With Combined Outcome of Fridericia-Corrected QT Interval >500 ms and/or Change From Baseline >60 ms at Each Visit, During 6 Months After Bedaquiline Initiation
| Characteristic | Patients With QTcF >500 ms or Change >60 ms/Total Patients (%) (N = 420 Patients) | ECGs With QTcF >500 ms or Change >60 ms/Total ECGs (%) (n = 2955 ECGs) | Crude OR (95% CI) | Adjusted OR (95% CI)a |
|---|---|---|---|---|
| Age group, y | P = .83 | P = .15 | ||
| <30 | 27/119 (22.7) | 65/781 (8.3) | 1 | 1 |
| 30–49 | 69/247 (27.9) | 160/1769 (9.0) | 1.23 (.60–2.53) | 1.91 (.85–4.29) |
| ≥50 | 15/54 (27.8) | 29/405 (7.2) | 1.03 (.36–2.93) | 2.90 (.85–9.91) |
| Sex | P > .99 | P = .36 | ||
| Male | 75/278 (27.0) | 169/1982 (8.5) | 1 | 1 |
| Female | 36/142 (25.4) | 85/973 (8.7) | 1.00 (.52–1.92) | 1.40 (.68–2.88) |
| HIV positive | P = .18 | P = .008 | ||
| No | 36/110 (32.7) | 75/788 (9.5) | 1 | 1 |
| Yes | 75/310 (24.2) | 179/2167 (8.3) | 0.63 (.32–1.24) | 0.34 (.15–.75) |
| Hypertension | P = .02 | P = .02 | ||
| No | 108/388 (27.8) | 249/2743 (9.1) | 1 | 1 |
| Yes | 3/32 (9.4) | 5/212 (2.4) | 0.14 (.03–.73) | 0.13 (.02–.86) |
| Diabetes | P = .05 | P = .06 | ||
| No | 109/401 (27.2) | 252/2823 (8.9) | 1 | 1 |
| Yes | 2/19 (10.5) | 2/132 (1.5) | 0.12 (.01–1.03) | 0.11 (.01–1.31) |
| Levofloxacinb | P = .06 | P = .37 | ||
| No | 1/1 (100) | 22/133 (16.5) | 1 | 1 |
| Yes | 110/419 (26.3) | 232/2822 (8.2) | 0.48 (.23–1.04) | 0.68 (.29–1.58) |
| Clofazamineb | P = .07 | P = .59 | ||
| No | 1/2 (50.0) | 25/123 (20.3) | 1 | 1 |
| Yes | 110/418 (26.3) | 229/2832 (8.1) | 0.51 (.25–1.06) | 0.80 (.36–1.77) |
| Moxifloxacinb | P = .72 | P = .44 | ||
| No | 110/413 (26.6) | 253/2924 (8.7) | 1 | 1 |
| Yes | 1/7 (14.3) | 1/31 (3.2) | 0.54 (.02–15.44) | 0.25 (.01–10.82) |
| Delamanidb | P = .26 | P = .82 | ||
| No | 107/408 (26.2) | 246/2889 (8.5) | 1 | 1 |
| Yes | 4/12 (33.3) | 8/66 (12.1) | 2.08 (.59–7.35) | 1.17 (.30–4.58) |
| Lopinavir/ritonavirb | P = .96 | P = .53 | ||
| No | 83/320 (25.9) | 200/2343 (8.5) | 1 | 1 |
| Yes | 28/100 (28.0) | 54/612 (8.8) | 1.02 (.51–2.01) | 0.79 (.37–1.68) |
| Metoclopramideb | P = .02 | P = .42 | ||
| No | 95/353 (26.9) | 250/2832 (8.8) | 1 | 1 |
| Yes | 16/67 (23.9) | 4/123 (3.3) | 0.23 (.07–.80) | 0.59 (.16–2.22) |
| Amitriptyline | P = .84 | P = .96 | ||
| No | 110/416 (26.4) | 253/2946 (8.6) | 1 | 1 |
| Yes | 1/4 (25.0) | 1/9 (11.1) | 0.63 (.01–48.05) | 0.89 (.01–156.80) |
| Haloperidolb | P = .57 | P = .69 | ||
| No | 110/411 (26.8) | 253/2944 (8.6) | 1 | 1 |
| Yes | 1/9 (11.1) | 1/11 (9.1) | 2.17 (.15–31.94) | 1.79 (.10–31.32) |
| Cotrimoxazoleb | P = .99 | P = .37 | ||
| No | 38/120 (31.7) | 78/943 (8.3) | 1 | 1 |
| Yes | 73/300 (24.3) | 176/2012 (8.7) | 1.00 (.54–1.83) | 1.75 (.51–6.06) |
| Azole antifungalsb | P = .01 | P < .001 | ||
| No | 89/355 (25.1) | 212/2753 (7.7) | 1 | 1 |
| Yes | 22/65 (33.8) | 42/202 (20.8) | 2.82 (1.26–6.30) | 5.61 (2.26–13.91) |
Abbreviations: CI, confidence interval; ECG, electrocardiogram; HIV, human immunodeficiency virus; OR, odds ratio; QTcF, Fridericia-corrected QT interval.
aAdjusted for age, sex, and visit week (a priori), HIV status, hypertension, diabetes, and azole antifungals.
bTaking the medication concomitant with bedaquiline at the time of the ECG measurement.