Table 2.
Primary Efficacy Analysis in the Microbiologically Eligible and the Assessable Populations.*
| Outcome | Microbiologically Eligible Population | Assessable Population | ||||||
|---|---|---|---|---|---|---|---|---|
| Control (N = 768) | Rifapentine– Moxifloxacin (N = 791) | Rifapentine (N = 784) | Total (N = 2343) | Control (N = 726) | Rifapentine– Moxifloxacin (N = 756) | Rifapentine (N = 752) | Total (N = 2234) | |
| Favorable | ||||||||
| Participants with outcome — no. (%) | 656 (85.4) | 668 (84.5) | 645 (82.3) | 1969 (84.0) | 656 (90.4) | 668 (88.4) | 645 (85.8) | 1969 (88.1) |
| Adjusted difference from control — percentage points (95% CI) | NA | 1.0 (−2.6 to 4.5) | 3.0 (−0.6 to 6.6) | NA | NA | 2.0 (−1.1 to 5.1) | 4.4 (1.2 to 7.7) | NA |
| Participant had negative culture at month 12 — no. (%) | 643 (83.7) | 656 (82.9) | 636 (81.1) | 1935 (82.6) | 643 (88.6) | 656 (86.8) | 636 (84.6) | 1935 (86.6) |
| Participant was seen at month 12 but no sputum was produced or cultures were contaminated but without evidence of M. tuberculosis — no. (%) | 13 (1.7) | 12 (1.5) | 9 (1.1) | 34 (1.5) | 13 (1.8) | 12 (1.6) | 9 (1.2) | 34 (1.5) |
| Unfavorable | ||||||||
| Participants with outcome — no. (%) | 112 (14.6) | 123 (15.5) | 139 (17.7) | 374 (16.0) | 70 (9.6) | 88 (11.6) | 107 (14.2) | 265 (11.9) |
| Outcome related to tuberculosis — no. (%) | 24 (3.1) | 45 (5.7) | 75 (9.6) | 144 (6.1) | 24 (3.3) | 45 (6.0) | 75 (10.0) | 144 (6.4) |
| Two consecutive positive cultures at or after week 17† | 11 (1.4) | 34 (4.3) | 63 (8.0) | 108 (4.6) | 11 (1.5) | 34 (4.5) | 63 (8.4) | 108 (4.8) |
| Participant not seen at month 12 but had positive culture when last seen | 11 (1.4) | 3 (0.4) | 4 (0.5) | 18 (0.8) | 11 (1.5) | 3 (0.4) | 4 (0.5) | 18 (0.8) |
| Clinical diagnosis of tuberculosis recurrence and treatment restarted | 2 (0.3) | 8 (1.0) | 8 (1.0) | 18 (0.8) | 2 (0.3) | 8 (1.1) | 8 (1.1) | 18 (0.8) |
| Outcome not related to tuberculosis — no. (%) | 46 (6.0) | 43 (5.4) | 32 (4.1) | 121 (5.2) | 46 (6.3) | 43 (5.7) | 32 (4.3) | 121 (5.4) |
| Consent withdrawn during treatment period with no adverse event reported | 14 (1.8) | 15 (1.9) | 11 (1.4) | 40 (1.7) | 14 (1.9) | 15 (2.0) | 11 (1.5) | 40 (1.8) |
| Change in treatment because of adverse event | 8 (1.0) | 16 (2.0) | 9 (1.1) | 33 (1.4) | 8 (1.1) | 16 (2.1) | 9 (1.2) | 33 (1.5) |
| Death during treatment period | 7 (0.9) | 3 (0.4) | 3 (0.4) | 13 (0.6) | 7 (1.0) | 3 (0.4) | 3 (0.4) | 13 (0.6) |
| Loss to follow-up during treatment period | 8 (1.0) | 2 (0.3) | 2 (0.3) | 12 (0.5) | 8 (1.1) | 2 (0.3) | 2 (0.3) | 12 (0.5) |
| Consent withdrawn during treatment period after occurrence of adverse event | 2 (0.3) | 3 (0.4) | 3 (0.4) | 8 (0.3) | 2 (0.3) | 3 (0.4) | 3 (0.4) | 8 (0.4) |
| Treatment changed or restarted for other reasons | 7 (0.9) | 4 (0.5) | 4 (0.5) | 15 (0.6) | 7 (1.0) | 4 (0.5) | 4 (0.5) | 15 (0.7) |
| Not assessable | ||||||||
| Participants with outcome — no. (%) | 42 (5.5) | 32 (4.0) | 35 (4.5) | 109 (4.7) | NA | NA | NA | NA |
| Participant not seen at month 12 but had negative culture when last seen | 31 (4.0) | 22 (2.8) | 23 (2.9) | 76 (3.2) | NA | NA | NA | NA |
| Treatment discontinued because of pregnancy | 8 (1.0) | 5 (0.6) | 4 (0.5) | 17 (0.7) | NA | NA | NA | NA |
| Death unrelated to tuberculosis during follow-up | 3 (0.4) | 8 (1.0) | 3 (0.4) | 14 (0.6) | NA | NA | NA | NA |
| Violent or accidental death during treatment period | 0 | 0 | 1 (0.1) | 1 (<0.1) | NA | NA | NA | NA |
| Exogenous reinfection confirmed on WGS | 0 | 0 | 1 (0.1) | 1 (<0.1) | NA | NA | NA | NA |
The assessable population included the participants in the microbiologically eligible population who met the criteria for favorable or unfavorable status with respect to the primary outcome. NA denotes not applicable, and WGS whole-genome sequencing.
A mong the participants who had a microbiologically unfavorable outcome, one in the rifapentine–moxifloxacin group had an isolate of recurrent Mycobacterium tuberculosis that showed phenotypic evidence of resistance to isoniazid plus rifampin but was susceptible to isoniazid and rifampin on line-probe molecular testing (WGS results were not available) and three in the rifapentine group had isolates of recurrent M. tuberculosis that showed evidence of resistance to isoniazid plus rifampin (WGS results were not available).