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.