TABLE 4.
Parameter | AUEC0–24 (s · h) | TT24 (s) |
---|---|---|
Geometric mean value (% CV) | ||
Phase 1 (DE alone) | 1,508 (16.9) | 29.2 (25.4) |
Phase 2 (DE + COBI separated) | 1,964 (12.2) | 42.5 (27.8) |
Phase 3 (DE + COBI simultaneously) | 2,038 (10.9) | 45.4 (28.8) |
GMR (90% CI) for comparison of phases | ||
Phase 2 vs phase 1 | 1.30 (1.21–1.39)b | 1.46 (1.30–1.61)b |
Phase 3 vs phase 1 | 1.33 (1.22–1.44)b | 1.51 (1.24–1.78)b |
AUEC0–24, area-under-the-time-effect curve from time zero to 24 h; TT24, thrombin time at 24 h; COBI, cobicistat; CV, coefficient of variation; CI, confidence interval.
P < 0.001, based on a paired Student t test.