Table 2.
Bioequivalence pharmacokinetic studies comparing darunavir boosted with ritonavir or with cobicistat either as single agents or in FDC with darunavir
| Study | Geometric mean ratio (90% CI)
|
|||
|---|---|---|---|---|
| AUC (mg·h/L) |
C max (mg/L) |
C trough (mg/L) |
||
| Mathias et al10 | DRV 800 mg qd + RTV 100 mg qd (n=31) | 1.02 (0.97–1.06) | 1.03 (1.00–1.06) | 0.69 (0.59–0.82) |
| DRV 800 mg qd + COBI 150 mg qd (n=33) | ||||
| Kakuda et al26 | GS003 | 0.97 (0.92–1.02) | 0.97 (0.92–1.01) | 0.69 (0.60–0.81) |
| DRV 800 mg qd + RTV 100 mg qd (n=32) | ||||
| DRV/COBI 800/150 mg qd (n=33) | ||||
| GS004 | 0.99 (0.94–1.04) | 1.00 (0.96–1.04) | 0.74 (0.63–0.86) | |
| DRV 800 mg qd + RTV 100 mg qd (n=32) | ||||
| DRV/COBI 800/150 mg qd (n=33) | ||||
| Kakuda et al24 | Fasted conditions | 0.96 (0.94–1.02) | 0.99 (0.94–1.04) | NR |
| DRV 800 mg qd + COBI 150 mg qd (n=72) | ||||
| DRV/COBI 800/150 mg qd (n=74) | ||||
| Fed conditions | 0.98 (0.93–1.03) | 0.97 (0.93–1.01) | NR | |
| DRV 800 mg qd + COBI 150 mg qd (n=38) | ||||
| DRV/COBI 800/150 mg qd (n=40) | ||||
Abbreviations: FDC, fixed-drug combination; DRV, darunavir; RTV, ritonavir; COBI, cobicistat; NR, not reported; CI, confidence interval; qd, every day.