Table 2.
LNG and EE PK Parameters in Women taking COCs (Control, n=10) or COCs + Ritonavir (Ritonavir, n=5)
| LNG | EE | |||||||
|---|---|---|---|---|---|---|---|---|
| Parameter | Control arm | Ritonavir arm | Change. (%) | p value | Control Arm | Ritonavir arm | Change (%) | p value |
| AUClasta | 243 ±83 | 321 ±61 | 32.0 | 0.033 | 3270 ±744 | 3867 ±976 | 18.2 | 0.33 |
| AUCTa | 113 ±37 | 150 ±28 | 32.6 | 0.029 | 1848 ±433 | 2251 ±567 | 21.8 | 0.27 |
| Cmaxb | 7.62 ±2.29 | 9.68 ±1.81 | 27.0 | 0.044 | 163.3 ±43.8 | 218.3 ±73.4 | 33.7 | 0.26 |
| Cminb | 3.70 ±1.29 | 4.97 ±1.15 | 34.4 | 0.043 | 49.2 ±14.1 | 53.3 ±14.7 | 8.5 | 0.65 |
| Tmax (h) c | 1.5 (0.2,3.8) 42.6 |
2.0 (1.1,3.9) 46.2 |
33.3 | 0.28 | 1.0 (1.0,2.8) 28.4 |
1.0 (1.0,2.9) 31.3 |
0.0 | 0.87 |
| T1/2 (h) c | (34.5,89.7) 1.23 |
(37.6,66.8) 1.02 |
8.2 | 0.77 | (24.9,49.1) 15.6 |
(29.8,32.0) 13.2 |
10.5 | 0.30 |
| CL(L/h) c | (0.96,2.65) 82.7 |
(0.80,1.27) 71.8 |
−16.7 | 0.055 | (13.0,28.5) 626 |
(10.5,19.0) | −15.1 | 0.19 |
| Vss (L) c | (51.2,238.3) | (44.0,93.4) | −13.2 | 0.25 | (427.1730) | 475 (370,671) | −24.1 | 0.30 |
AUClast: area under the concentration-time curve till the last observation (72h) of the last dose. AUCτ: area under the concentration curve (24h) of the last dose during the 21-day cycle. Units for LNG AUC (includes AUClast, AUCτ) are ng/mL*h, Units for EE AUC (includes AUClast, AUCτ) are pg/mL*h. Data presented as mean±SD as these parameters follow normal distribution by Shapiro-Wilk test. Statistical tests were performed with non-paired, 1-tailed t test with Welch’s correction for LNG with the hypothesis that exposures would be higher in the Ritonavir arm. 2-tailed t tests were used for EE because there was no clear direction of the change for EE.
Cmax: maximum observed concentration for the last dose of the cycle. Cmin: observed concentration 24h after the last dose of the cycle. Units of LNG Cmax, Cmin are ng/mL; Units of EE Cmax, Cmin are pg/mL.
Tmax: Time for maximum concentration observed. T1/2 (h): Half-life calculated by NCA method. CL: drug clearance calculated by NCA method. Vss: volume at steady state calculated by NCA method. Data are presented as median (95% Confidence interval) as Tmax, T1/2, CL and Vss don’t follow normal distribution, non-parametric tests (Mann-Whitney test) were used for statistical tests of these four parameters. 2-tailed tests were used for these parameters except for LNG CL where 1-tailed was used with the hypothesis that the clearance was lower in Ritonavir arm.