TABLE 3.
Danoprevir steady-state pharmacokinetic parameters for the DNVr regimen in HCV genotype 1-infected prior null responder patients
| DNV steady-state pharmacokinetic parametera | Value for the parameter (n = 23)c |
|---|---|
| AUC0-τ,SS (ng · h/ml)b | 224 (143) |
| Cmax,SS (ng/ml) | 90.9 (62.2) |
| Cmin (ng/ml)b | 1.55 (3.26) |
| Median Tmax (h [range]) | 2.05 (0.50–8.00) |
| t1/2 (h)b | 2.19 (1.58) |
| Median Ctrough,SS range (weeks 2 to 12 [ng/ml])b | 0.74–1.53 |
| CLSS/F (liters/h)b | 715 (543) |
| VSS/F (liters)b | 2,230 (2,030) |
AUC0-τ,ss, the steady-state area under the concentration-time curve over the dosing interval from 0 to τ; CLSS/F, apparent oral clearance at steady state; Cmax,SS, the observed maximum plasma concentration at steady state; Cmin, minimum plasma concentration within a dosing interval; Ctrough,SS, the observed trough concentration at steady state; DNVr, ritonavir-boosted danoprevir; PK, pharmacokinetic; Tmax, time to maximum plasma concentration; t1/2, drug elimination half-life; VSS/F, apparent oral volume of distribution at steady state.
PK data are not available for the one patient who discontinued treatment at week 2.
All data are means (standard deviations) unless otherwise stated. DNVr was administered at 100/100 mg q12h.