TABLE 5.
Summary of plasma PK parameters by sex after IM cabotegravir injection
| PK parameter | Geometric mean (%CVb), range a | Geometric LS mean | Geometric LS mean (90% CI) | |
|---|---|---|---|---|
| Overall (n = 15) | Men (n = 8) | Women (n = 7) | Women vs. men | |
| Cmax, μg/mL b | 5.04 (62), 1.2–11.2 | 6.26 | 3.94 | 0.63 (0.34–1.15) |
| tmax, median (range), d | 6.9 (3.9–52.2) | — | — | — |
| AUC0‐Wk4, μg*h/mL | 2141 (59), 650–5063 | 2285 | 1990 | 0.87 (0.47–1.62) |
| AUC0‐Wk8, μg*h/mL | 3214 (40), 1106–6372 | 3342 | 3073 | 0.92 (0.60–1.42) |
| AUC0‐Wk12, μg*h/mL | 3639 (36), 1442–6555 | 3710 | 3570 | 0.96 (0.64–1.44) |
| AUC0‐t, μg*h/mL | 3992 (25), 2811–6547 | — | — | — |
| AUC0‐∞, μg*h/mL | 4172 (24), 2839‐6597 c | 3829 | 4547 | 1.19 (0.91–1.54) |
| t1/2, d | 19.1 (81), 9.1–148.6 c | 14.6 | 25.1 | 1.72 (0.78–3.79) |
| KALA, h | 0.0014 (97) c | — | — | — |
| Time > PA‐IC90, dd | 78.3 (46) | 66.5 | 94.3 | — |
AUC0‐Wk4, area under the concentration–time curve from time 0 to Week 4; AUC0‐Wk8, area under the concentration–time curve from time 0 to Week 8; AUC0‐Wk12, area under the concentration–time curve from time 0 to Week 12; AUC0‐t, area under the concentration–time curve from time 0 to the last quantifiable time point; AUC0‐∞, area under the concentration–time curve from time 0 to infinity; CI, confidence interval; Cmax, maximum observed concentration; %CVb, geometric coefficient of variation; IM, intramuscular; KA, absorption rate constant; LA, long acting; LS, least squares; PA‐IC90, in vitro protein‐adjusted 90% maximal inhibitory concentration; PK, pharmacokinetics; t1/2, apparent terminal phase half‐life; tmax, time to first occurrence of maximum observed concentration.
Except where noted for tmax.
The lower limit of quantification was 0.025 μg/mL.
n = 14. dPA‐IC90 = 0.166 μg/mL.