Table 1.
Patients' demographic and clinical characteristics
| Bedaquiline group (n=688) | Injectable group (n=699) | p value | ||
|---|---|---|---|---|
| Patient characteristics | ||||
| Median age | 42 (33–51) | 34 (28–42) | <0·0001 | |
| Sex | ||||
| Male | 423 (61%) | 389 (56%) | 0·032 | |
| Female | 265 (39%) | 310 (44%) | .. | |
| PLHIV | 493 (72%) | 474 (68%) | 0·13 | |
| On antiretroviral therapy | 478/493 (97%) | 440/474 (93%) | 0·0054 | |
| Microbiological findings at baseline* | ||||
| AFB smear positive | 297/604 (49%) | 248/570 (44%) | 0·059 | |
| Culture positive | 342/470 (73%) | 334/460 (73%) | 1·00 | |
| Culture, AFB, or Xpert positive | 602/661 (91%) | 605/663 (91%) | 0·99 | |
| Previous treatment | ||||
| Previously treated for drug susceptible tuberculosis† | 274 (40%) | 286 (41%) | 0·72 | |
| Treatment received | ||||
| Moxifloxacin or Levofloxacin | 688 (100%) | 699 (100%) | .. | |
| Bedaquiline | 688 (100%) | 0 (0%) | .. | |
| Clofazimine | 688 (100%) | 699 (100%) | .. | |
| Injectable | .. | 699 (100%) | .. | |
| Amikacin | .. | 106 (15%) | .. | |
| Kanamycin | .. | 595 (85%) | .. | |
| Capreomycin | .. | 1 (<1%) | .. | |
| Streptomycin | .. | 0 | .. | |
| Mean number of other drugs received (SD) | 3·0 (0·2) | 2·9 (0·2) | .. | |
| End-of-treatment outcomes | ||||
| Treatment success | 507 (74%) | 421 (60%) | .. | |
| Failure | 5 (1%) | 14 (2%) | .. | |
| Died during treatment | 117 (17%) | 159 (23%) | .. | |
| Lost to follow-up | 59 (9%) | 105 (15%) | .. | |
| Post-treatment outcomes | ||||
| Returned for treatment (recurrence after success) | 1 (<1%) | 4 (1%) | .. | |
| Post-treatment deaths | 45 (7%) | 40 (6%) | .. | |
| Final treatment outcomes 24 months post-initiation‡ | ||||
| Treatment success | 478 (69%) | 396 (57%) | .. | |
| Treatment failure and recurrence | 4 (1%) | 17 (2%) | .. | |
| Died | 162 (24%) | 199 (28%) | .. | |
| Lost to follow-up | 44 (6%) | 87 (12%) | .. | |
Data are median (IQR), n (%), n/N (%), or mean (SD). AFB=acid fast bacilli. PLHIV=people living with HIV.
Percentages calculated based on the number of patients with a result at baseline (baseline refers to 4 weeks before or 2 weeks after treatment initiation).
Among patients in the bedaquiline group, 209 were treated for recurrence, 42 previous treatment failures, 21 retreatments due to loss to follow-up, and two unknown reasons; among patients in the injectable group, 201 were recurrences, 43 previous treatment failures, 36 retreatments due to loss to follow-up, and six unknown reasons.
Events are classified as following: all people dying in the post-treatment follow-up period up to 24 months after treatment initiation were reclassified as deaths, regardless of other post-treatment outcomes (ie, recurrence).