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. 2021 Jun 28;15:2815–2830. doi: 10.2147/DDDT.S281639

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 Two additional exclusions in PP resulting in total n=105 (one inadequate amount of drug and one withdrawn not for treatment failure).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.