Table 2.
Efficacy of Pretomanid-Containing Regimens
Trial | Regimen | Phenotype | mITT at 6 Months | PP | ||
---|---|---|---|---|---|---|
Favorable | Unfavorable | Favorable | Unfavorable | |||
NIX-TB^ | Pa200 QD, B400 QD x 2 weeks then B200 3x/week, L1200 QD X 30 weeks | XDR (n=71) | 63* (90%) | 7 (10%) | 62 (91%) | 6 (9%) |
TI/NR MDR (n=38) | 35 (95%) | 2(5%) | 35 (95%) | 2 (5%) | ||
STAND | Pa100 M400 Z1500 X 17 weeks | DS-TB | 38 (66.7%) | 19 (33.3%) | 38 (73.1%) | 14 (26.9%) |
STAND | Pa200 M400 Z1500 X 17 weeks | DS-TB | 46 (75.4%) | 15 (24.6%) | 46 (80.7%) | 11 (19.3%) |
STAND | Pa200 M400 Z1500 X 26 weeks | DS-TB | 43 (76.8%) | 13 (23.2%) | 43 (91.5%) | 4 (8.5%) |
STAND | H75 R150 Z400 E275 X 8 wks; H75 R150 wks 9 to 26 | DS-TB | 52 (86.7%) | 8 (13.3%) | 52 (98.1%) | 1 (1.9%) |
STAND | Pa200 M400 Z1500 X 26 weeks | MDR-TB | 10 (90.9%) | 1 (9.1%) | 10 (100.0%) | 0 (0.0%) |
Notes: *The following categorical variables had no appreciate impact on mITT: HIV status, linezolid regimen (600 mg BID or 1200 QD), age (above or below median), gender, race (black vs white/other), cavitation, TTP at baseline from MGIT (above or below median). ^NIX-TB- Two exclusions in mITT resulting in total n=107 (non-TB related death in follow up and lost to follow up after end of treatment). Two additional exclusions in PP resulting in total n=105 (one inadequate amount of drug and one withdrawn not for treatment failure).
Abbreviations: mITT, modified intention to treat; PP, per protocol.