TABLE 3.
Summary of RTV PK parameters and treatment comparisonsa
| PK parameter | Geometric mean value (% CV) for the following treatments: |
Adjusted geometric mean ratio (90% CI) for the following treatment comparisons: |
|||
|---|---|---|---|---|---|
| B (n = 17) | C (n = 18) | D (n = 36) | D vs Cb (90% CI) | B vs Cc (90% CI) | |
| Cmax | 933 ng/ml (37) | 2,327 ng/ml (36) | 2,188 ng/ml (36) | 1.02 (0.957, 1.09) | 0.401 (0.331, 0.484) |
| AUCtau | 7,373 ng · h/ml (35) | 11,994 ng · h/ml (28) | 12,138 ng · h/ml (27) | 1.07 (1.03, 1.10) | 0.615 (0.509, 0.742) |
| C24 | 78.2 ng/ml (65) | 54.5 ng/ml (52) | 67.9 ng/ml (51) | 1.22 (1.12, 1.32) | |
a
Treatment B, BMS-663068 at 600 mg BID plus RTV at 100 mg QD; treatment C, ATV at 300 mg QD plus RTV at 100 mg QD; treatment D, BMS-663068 at 600 mg BID plus ATV at 300 mg QD plus RTV at 100 mg QD; AUCtau, area under the plasma concentration-time curve in one dosing interval (24 h); CI, confidence interval; Cmax, maximum concentration in plasma; C24, plasma concentration at 24 h postdose; CV, coefficient of variation; PK, pharmacokinetic; RTV, ritonavir.
b
Only data for subjects randomized to treatment sequence A-C-D or A-D-C were included in the analysis.
c
This was a between-subject comparison; no subject received both treatment B and treatment C.