Table 1.
Participant Characteristics
| Analysis Cohort (n = 1,503) | Validation Cohort (n = 752) | Full Cohort (n = 2,255) | |
|---|---|---|---|
| Demographics | |||
| Arm | |||
| 6-mo control | 489 (33) | 242 (32) | 731 (32) |
| 4-mo rifapentine | 515 (34) | 246 (33) | 761 (34) |
| 4-mo rifapentine–moxifloxacin | 499 (33) | 264 (35) | 763 (34) |
| Pyrazinamide daily dose | |||
| 1,000 mg | 875 (58) | 447 (59) | 1,322 (59) |
| 1,500 mg | 587 (39) | 277 (37) | 864 (38) |
| 2,000 mg | 41 (3) | 28 (4) | 69 (3) |
| Age, yr | 31 (13–77) | 31 (14–81) | 31 (13–81) |
| Male sex | 1,068 (71) | 532 (71) | 1,600 (71) |
| Height, cm | 167 (140–200) | 167 (140–194) | 167 (140–200) |
| Weight, kg | 53 (40–118) | 53 (40–122) | 53 (40–122) |
| BMI, kg/m2 | 19.0 (13.4–40.9) | 19.1 (12.8–45.4) | 19.0 (12.8–45.4) |
| Race | |||
| Black | 1,057 (70) | 544 (72) | 1,601 (71) |
| Asian | 176 (12) | 88 (12) | 264 (12) |
| Mixed/multiracial | 248 (17) | 111 (15) | 359 (16) |
| White | 22 (1) | 9 (1) | 31 (1) |
| Sub-Saharan African site | 1,120 (75) | 562 (75) | 1,682 (75) |
| Clinical factors | |||
| Cavitation on chest radiograph* | |||
| Absent | 392 (26) | 186 (25) | 578 (26) |
| <4 cm | 509 (34) | 240 (32) | 749 (33) |
| ≥4 cm | 595 (40) | 317 (42) | 912 (40) |
| Extent of disease on chest radiograph* | |||
| Lesions <25% thoracic area | 263 (18) | 128 (17) | 391(17) |
| Lesions 25% to <50% thoracic area | 657 (44) | 342 (46) | 999 (44) |
| Lesions ≥50% thoracic area | 576 (38) | 273 (36) | 849 (38) |
| WHO smear grade† | |||
| Negative | 53 (4) | 27 (4) | 80 (4) |
| Scanty or 1–9 acid-fast bacilli | 254 (17) | 137 (18) | 391 (17) |
| 1+ | 347 (23) | 167 (22) | 514 (23) |
| 2+ | 456 (30) | 212 (28) | 668 (30) |
| 3+ | 392 (26) | 207 (28) | 599 (27) |
| Karnofsky score | 90 (60–100) | 90 (60–100) | 90 (60–100) |
| Living with HIV‡ | 124 (8) | 61 (8) | 185 (8) |
| History of diabetes | 44 (3) | 25 (3) | 69 (3) |
| Evaluable PK samples | |||
| Total evaluable | 4,633 | 2,345 | 6,978 |
| Intensive sampling (>6 samples) | 266 (6) | 171 (7) | 437 (6) |
| Below limit of quantification | 4 (0.09) | 5 (0.2) | 9 (0.1) |
Definition of abbreviations: BMI = body mass index; PK = pharmacokinetic; WHO = World Health Organization.
Data are expressed as n (%); continuous variables are expressed as median (range). The entire PK dataset was split into model analysis and validation cohorts. The split was performed by randomly stratifying participants on the basis of clinical site and HIV status, which aligned with the original trial design.
*
Sixteen participants were missing chest X-ray readouts.
†
Three participants were missing WHO smear grade.
‡
One participant had unknown HIV status.