TABLE 4.
Pharmacokinetic parameters of Sofosbuvir, GS‐331007, and Velpatasvir during on‐ and off‐dialysis (n = 12).
| Pharmacokinetic parameters | Sofosbuvir | GS‐331007 | Velpatasvir | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Off‐dialysis | On‐dialysis | p value | Off‐dialysis | On‐dialysis | p value | Off‐dialysis | On‐dialysis | p value | |
| T max (h) | 0.5 (0.5–6.0) | 0.8 (0.5–5.0) | 0.786 | na | na | na | 3.5 (2.0–12.0) | 4.5 (2.5–6.0) | 0.153 |
| C max (ng/mL) | 2349.64 (1157.58–3562.98) | 2280.57 (967.03–3880.99) | 0.754 | na | na | na | 534.40 (173.30–1093.85) | 497.75 (201.73–1007.96) | 0.480 |
| AUC0‐24h (ng.h/mL) | 2881 (1645‐,5084) | 2773 (1029‐4681) | 0.937 | 32,330 (13,198‐67,911) | 21,400 (13,694‐31,382) | 0.006 | 3742 (1249‐9351) | 4613 (1732‐8405) | 0.347 |
| T 1/2 (h) | 1.21 (0.62–1.77) | 1.18 (0.75–1.11) | 0.286 | na | na | na | 7.26 (4.83–10.74) | 6.18 (4.97–8.17) | 0.050 |
| Kel (1/h) | 0.574 (0.392–1.112) | 0.599 (0.264–0.930) | 0.213 | na | na | na | 0.095 (0.065–0.143) | 0.113 (0.085–0.139) | 0.062 |
| CL‐dialysis (mL/min) | na | 9.35 (8.72–15.11) | na | na | 8.89 (8.52–14.07) | na | na | na | na |
| AUC0‐24h ‐on/AUC0‐24h ‐off‐dialysis ratio | na | 1.04 (0.42–1.64) | na | na | 0.68 (0.38–1.47) | na | na | 1.41 (0.36–3.20) | na |
Note: Data are presented as median (range).
Abbreviations: AUC0‐24h, area under the concentration–time curve from time 0 to 24 h; C max, maximum plasma concentration; CL, clearance; Kel, elimination rate constant; na, not applicable; T max, time to maximum plasma concentration; T 1/2, half‐life.