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]

CmaxAUC0-∞ClPOt1/2fm (%)fgfhfa
LiverKidney
µg/mlµg·h/mll/hh%%%
Observed2.2 (43)43.7 (45)1.1 (45)14.4 (19)N/A
HLMs only5.8 (19)199.6 (55)0.3 (50)21.1 (40)99.20.89899100
HLMs and HIMs2.7 (24)89.4 (55)0.56 (50)21.1 (40)99.20.84699100
HLMs, HIMs, HKMs2.6 (24)60.4 (43)0.8 (44)15.3 (37)79.720.34699100