Table 4.
Mean (%CV) Sofosbuvir, GS‐331007, and Ledipasvir Exposures
| Children 3 to <6 Years Old (n = 13) | Adults (n = 2,113)* | Children 3 to <6 Years Old vs. Adults % GMR (90% CI) | |
|---|---|---|---|
| Sofosbuvir† | |||
| AUCtau (ng·h/mL) | 2,500 (16.5)† | 1,380 (34.0) | 188 (143, 246) |
| Cmax (ng/mL) | 1420 (55.5) | 659 (34.0) | 192 (161, 230) |
| GS‐331007 | |||
| AUCtau (ng·h/mL) | 11,700 (29.1) | 12,500 (29.2) | 94 (82, 107) |
| Cmax (ng/mL) | 1,000 (23.3) | 736 (28.2) | 138 (121, 157) |
| Ledipasvir | |||
| AUCtau (ng·h/mL) | 9,320 (35.2) | 8,530 (60.8) | 120 (93, 156) |
| Cmax (ng/mL) | 531 (28.5) | 364 (51.4) | 158 (126, 197) |
Data are presented as mean (% coefficient of variation), unless otherwise specified.
Parameters presented to three significant digits.
*
Squires and Balistreri27 and n = 1,542 for sofosbuvir parameters in adults.
†
For sofosbuvir AUCtau in children 3 to <6, n = 3.
Abbreviations: CV, coefficient of variation; GMR, geometric mean ratio.