TABLE 2.
Inhibitory sigmoid Emax parameters for delamanid AUC0–24/MIC from mouse and HFS studies and human EBA trialsa
| Study type | Estimate (95% CI) of best-fit value of: |
|||
|---|---|---|---|---|
| Emax (log10 CFU) | Hill coefficient | EC50 (AUC0–24/MIC) | EC80 (AUC0–24/MIC) | |
| Mouse | 2.96 (2.63–3.28) | 1 (fixed) (NE) | 63 (40–99) | 252 (139–649) |
| HFS | ||||
| Log-phase growth | 1.49 (1.26–1.82) | 1.86 (1.16–3.16) | 240 (171–369) | 506 (306–777) |
| pH 5.8 culture | 2.35 (1.90–2.79) | 1.5 (imprecise) | 207 (87–361) | 522 (210–910) |
| Human EBA | 0.626 (0.448–0.835) | 4.39 (1.30–8.14) | 125 (57.9–213) | 171 (79.0–292) |
Emax, maximum killing from time-matched untreated controls in the mouse and HFS studies or from baseline in the EBA trials; EC50 and EC80, AUC0–24/MIC required for 50% and 80% of Emax, respectively; NE, not estimated.