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. 2018 Nov 8;15(11):e1002690. doi: 10.1371/journal.pmed.1002690

Table 4. Geometric means of pharmacokinetic parameters (Cmax, Cτ, and AUC0–τ) by BMI (≥median versus <median).

Injection Parameter Cohort 1 Cohort 2
≥Median BMI* <Median BMI* p-Value ≥Median BMI* <Median BMI* p-Value
1 n 41 33 26 33
Cmax (μg/ml) 1.82 2.56 0.014 1.35 2.37 <0.001
Cτ (μg/ml) 0.73 0.81 0.454 1.12 1.82 0.001
AUC0–τ (d*μg/ml) 99.09 130.12 0.010 27.47 48.24 <0.001
2 n 36 26 26 33
Cmax (μg/ml) 2.14 2.78 0.086 2.82 3.63 0.075
Cτ (μg/ml) 1.10 1.09 0.946 1.40 1.82 0.085
AUC0–τ (d*μg/ml) 132.21 165.50 0.051 111.83 150.36 0.025
3 n 33 24 24 33
Cmax (μg/ml) 2.93 3.48 0.272 2.57 3.90 0.005
Cτ (μg/ml) 1.17 1.39 0.289 1.53 1.74 0.394
AUC0–τ (d*μg/ml) 181.07 225.81 0.065 113.68 171.86 0.002
4 n 24 31
Cmax (μg/ml) 2.69 3.65 0.040
Cτ (μg/ml) 1.85 1.81 0.887
AUC0–τ (d*μg/ml) 123.14 152.50 0.116
5 n 24 26
Cmax (μg/ml) 3.27 4.18 0.112
Cτ (μg/ml) 1.92 1.87 0.881
AUC0–τ (d*μg/ml) 153.49 178.63 0.284

Includes plasma cabotegravir concentrations obtained from samples collected within defined post-injection sampling windows.

*Median BMI is 27.2 kg/m2 for females and 25.0 kg/m2 for males. AUC0–τ, area under the plasma concentration–time curve over the dosing interval; BMI, body mass index; Cmax, maximum plasma concentration; Cτ, trough concentration at the end of the dosing interval.