TABLE 4.
Simulated steady-state PK after single-dose administration of narlaprevir (part 1) and narlaprevir with ritonavir (part 2) in patients with compensated cirrhosis and in healthy subjectsa
| Investigated regimen | Parameter | GMEAN |
P/H | 90% CI |
||
|---|---|---|---|---|---|---|
| Cirrhotic patients (n = 8) | Healthy subjects (n = 8) | Lower | Upper | |||
| NVR at 200 mg (part 1) | AUCtau (ng · h/ml) | 4,607.2 | 1,944.0 | 2.37 | 1.50 | 3.74 |
| Cmax ss (ng/ml) | 618.9 | 370.5 | 1.67 | 1.14 | 2.45 | |
| NVR at 100 mg + RTV at 100 mg (part 2) | AUCtau (ng · h/ml) | 15,105.7 | 14,115.9 | 1.07 | 0.72 | 1.58 |
| Cmax ss (ng/ml) | 1,450.6 | 1,378.1 | 1.05 | 0.68 | 1.62 | |
a
AUCtau, area under narlaprevir concentration-time curve at steady state; Cmax ss, maximum narlaprevir concentration at steady state; P/H, patient/healthy subject ratio; GMEAN, geometric least square mean; NVR, narlaprevir; RTV, ritonavir.