TABLE 4.
Dolutegravir clinical pharmacokinetic outcomes recovered from observed data and PBPK model predictions from 1) HLMs only; 2) HLMs and HIMs; and 3) HLMs, HIMs, and HKMs [geometric mean and coefficient of variation (CV%) incorporating in vitro glucuronidation kinetics data from 1) HLMs only; 2) HLMs and HIMs; and 3) HLMs, HIMs, and HKMs]
|
Cmax |
AUC0-∞ |
ClPO |
t1/2 |
fm (%) |
fg |
fh |
fa |
||
|---|---|---|---|---|---|---|---|---|---|
| Liver |
Kidney |
||||||||
| µg/ml | µg·h/ml | l/h | h | % | % | % | |||
| Observed | 2.2 (43) | 43.7 (45) | 1.1 (45) | 14.4 (19) | N/A | ||||
| HLMs only | 5.8 (19) | 199.6 (55) | 0.3 (50) | 21.1 (40) | 99.2 | 0.8 | 98 | 99 | 100 |
| HLMs and HIMs | 2.7 (24) | 89.4 (55) | 0.56 (50) | 21.1 (40) | 99.2 | 0.8 | 46 | 99 | 100 |
| HLMs, HIMs, HKMs | 2.6 (24) | 60.4 (43) | 0.8 (44) | 15.3 (37) | 79.7 | 20.3 | 46 | 99 | 100 |