TABLE 3.
Cumulative fraction of response following 100-mg BID or 200-mg QD delamanid dosinga
| Study type | Plasma-equivalent PDT (AUC0–24/MIC) | CFR for population and dosage |
||
|---|---|---|---|---|
| Trial 204, 100 mg BID (n = 104) | Trial 213, 100 mg BID (n = 246) | Trial 213, 200 mg QD (n = 246) | ||
| Mouse | 252 | 100 | 95.9 | 89.3 |
| HFS | ||||
| Log-phase growth | 195b | 100 | 98.0 | 93.4 |
| pH 5.8 culture | 201b | 100 | 98.0 | 91.7 |
| Human EBA | 171 | 100 | 98.0 | 95.9 |
a
BID, twice daily; CFR, cumulative fraction of response; EBA, early bactericidal activity; HFS-TB, hollow-fiber system model of tuberculosis; n, number of patients; PDT, pharmacodynamic target; QD, once daily.
b
Plasma-equivalent PDT for the HFS-TB study was calculated by dividing the HFS-TB PDT with the mouse Kp.