Table 3.
Adverse Events Among Patients With Multidrug-resistant Tuberculosis Receiving a Bedaquiline- or Delamanid-Based Treatment Regimen
| Characteristic | Delamanid, n = 31, n (%) | Bedaquiline, n = 64, n (%) |
|---|---|---|
| Premature permanent discontinuation secondary to adverse event | 1 (3)a | 2 (3)b |
| EKG results | ||
| Mean baseline QTc | 397 (27) | 400 (22) |
| Mean follow-up EKGs (SD) | 9 (3) | 8 (4) |
| Highest mean follow-up QTc (SD) | 448 (26) | 432 (31) |
| Patients with follow-up QTc ≥ 500 ms | 2 (7)c | 1 (2)d |
| Mean largest QTc increase from baseline (SD) | 50 (31) | 31 (34) |
| Patients with QTc increase ≥ 60 ms | 9 (29) | 12 (19) |
| Laboratory follow-up results | ||
| Mean follow-up laboratory tests (SD) | 9 (3) | 8 (4) |
| White blood cell count < 2000/mm3 | 0 | 0 |
| Hemoglobin ≤ 7.9 g/dl | 2 (7) | 1 (2) |
| Platelets < 100 000 per microliter | 3 (10) | 6 (9) |
| Increase in serum creatinine > 2 times baseline | 5 (16) | 15 (23) |
| Potassium < 3.4 mEq/L | 0 | 0 |
| ALT > 3x time upper limit of normal | 4 (13) | 5 (8) |
| ALT > 5x time upper limit of normal | 1 (3) | 3 (5) |
Abbreviations: ALT, alanine transaminase; EKG, electrocardiogram; QT, Q wave to the end of the T wave; QTc, corrected QT interval; SD, standard deviation.
aReceived total of 18 weeks of delamanid, which was stopped along with all other treatment due to hepatotoxicity.
bBedaquiline stopped along with other treatment due to hepatoxicity and exfoliative dermatitis after 23 and 13 weeks, respectively.
cOccurred at 3 months (515 ms) and 5 months (501 ms); both cases had decrease of QTc 1 month later and did not have interruption of delamanid.
dOccurred at 3 months (508 ms) and had decreased QTc 1 month later; no interruption of bedaquiline.