Table 3.
Effect of selected covariates on asunaprevir steady-state AUC
| Covariate name | Covariate categories | n | Simulated ASV steady-state AUC (ng h/mL) | % Difference from reference (%) | |
|---|---|---|---|---|---|
| Median | 95% PI | ||||
| Baseline AST | 1st quartile (median = 28 IU/L) | 321 | 1162 | 568, 2278 | − 25.6 |
| 2nd quartile (median = 42 IU/L) | 299 | 1310 | 729, 2872 | − 16.1 | |
| 3rd quartile (median = 62 IU/L) | 309 | 1706 | 882, 3743 | 9.3 | |
| 4th quartile (median = 104 IU/L) | 310 | 2462 | 1250, 5064 | 57.7 | |
| All (median = 51 IU/L) | 1239 | 1561 | 729, 4042 | – | |
| Cirrhosis | No | 996 | 1406 | 695, 3241 | – |
| Yes | 242 | 2591 | 1206, 5251 | 84.3 | |
| Race | White | 722 | 1388 | 662, 3735 | – |
| Black | 74 | 1389 | 670, 3111 | 0.1 | |
| Japanese | 267 | 1945 | 986, 4393 | 40.1 | |
| Non-Japanese Asian | 156 | 2023 | 956, 4125 | 45.7 | |
| Formulation | Tablet | 376 | 1039 | 532, 2725 | − 40.3 |
| Soft-gel capsule | 863 | 1739 | 791, 4188 | – | |
PI prediction interval