Table 1.
Summary of LNG and EO PK parameters
| Plasma PK parameter | Geometric mean (95% CI) | GLS mean ratio (90% CI) | |
|---|---|---|---|
| OC alone (n = 19) | OC + CAB (n = 19) | (OC + CAB/OC alone) | |
| LNG | |||
| AUC 0–τ (ng × h ml –1 ) | 77.4 (64.5, 92.9) | 87.0 (72.1, 104.9) | 1.12 (1.07, 1.18) |
| C max (ng ml –1 ) | 6.86 (5.84, 8.06) | 7.20 (6.28, 8.26) | 1.05 (0.96, 1.15) |
| C τ (ng ml –1 ) | 2.41 (1.98, 2.95) | 2.59 (2.09, 3.22) | 1.07 (1.01, 1.15) |
| t max a (h) | 1.00 (0.5–2.5) | 1.00 (0.5–3.0) | ND |
| EO | |||
| AUC 0–τ (pg × h ml –1 ) | 773b (656, 911) | 800c (698, 916) | 1.02 (0.97, 1.08) |
| C max (pg ml –1 ) | 86.2 (72.4, 102.7) | 79.5 (68.0, 92.8) | 0.922 (0.83, 1.03) |
| C τ (pg ml –1 ) | 16.0b (12.5, 20.4) | 15.7c (12.9, 19.0) | 1.00 (0.92, 1.10) |
| t max a (h) | 1.00 (0.5–2.5) | 1.5 (0.5–2.6) | ND |
EO was not quantifiable at 24 h post dose for two subjects receiving OC alone and one subject receiving OC + CAB; therefore, EO AUC0–τ and Cτ were not reported for these cases. AUC0–τ, area under the plasma concentration–time curve over the dosing interval of duration τ; CAB, cabotegravir; Cmax, maximum observed plasma concentration; Cτ, concentration at the end of dosing interval; EO, ethinyl oestradiol; GLS, geometric least squares; LNG, levonorgestrel; ND, not determined; OC, oral contraceptive; PK, pharmacokinetic; tmax, time of Cmax.
a
Median (range)
b
n = 17
c
n = 18