| Dapivirine ([Mean [SD]) |
| Ring |
Pharmacokinetic Parameter |
Group A (N=17) |
Group B (N=16) |
| Plasma: |
| Ring 1 |
Cmax (pg/mL) (±SD) (%CV) |
347.6 (± 72.16) (20.76) |
358.5 (± 52.32) (14.60) |
| |
tmax (h)* |
170.00 (168.00-674.28) |
336.00 (168.00-338.00) |
| |
AUC0-24h (pg.h/mL) (±SD) (%CV) |
2939 (± 760.1) (25.86) |
3103 (± 833.2) (26.85) |
| |
AUC0-last (pg.h/mL) (±SD) (%CV) |
190600 (± 38490) (20.20) |
245500 (± 33200) (13.52) |
| |
Cprior to ring removal (pg/mL) (±SD) (%CV) |
260.2 (± 58.28) (22.40) |
259.8 (± 40.56) (15.61) |
| Ring 2 |
C0h (pg/mL) (±SD) (%CV) |
95.06 (± 49.86) (52.46) |
100.2 (± 43.18) (43.11) |
| |
Cprior to ring removal (pg/mL) (±SD) (%CV) |
270.4 (± 84.58) (31.28) |
293.3 (± 68.47) (23.35) |
| Ring 3 |
Cprior to ring removal (pg/mL) (±SD) (%CV) |
– |
389.5 (± 86.44) (22.19) |
| |
AUC0-24h (pg.h/mL) (±SD) (%CV) |
– |
8379 (± 1836) (21.91) |
| Vaginal fluid (collected by tear test strip) – Cervix: |
| Ring 1 |
Cmax (µg /g) (±SD) (%CV) |
61.22 (± 26.09) (42.63) |
55.54 (± 24.06) (43.32) |
| |
tmax (h) * |
24.80 (4.17 – 506.65) |
168.29 (24.17-338.37) |
| |
AUC0-24h (µg.h/g) (±SD) (%CV) |
759.9 (± 332.6) (43.77) |
653.9 (± 312.4) (47.77) |
| |
AUC0-last (µg.h/g) (±SD) (%CV) |
26070 (± 12850) (49.31) |
25440 (± 11750) (46.18) |
| |
C24h (µg /g) (±SD) (%CV) |
41.39 (± 23.05) (55.68) |
38.13 (± 20.14) (52.83) |
| |
Cprior to ring removal (µg /g) (±SD) (%CV) |
27.84 (± 19.28) (69.23) |
18.53 (± 12.80) (69.08) |
| Ring 2 |
C0h (µg /g) (±SD) (%CV) |
0.1856 (± 0.3102) (167.1) |
BLQ |
| |
Cprior to ring removal (µg /g) (±SD) (%CV) |
27.03 (± 12.40) (45.89) |
22.42 (± 12.79) (57.05) |
| Ring 3 |
Cprior to ring removal (µg /g) (±SD) (%CV) |
– |
40.06 (± 22.40) (55.90) |
| |
AUC0-24h (µg.h/g) (±SD) (%CV) |
– |
857.8 (± 418.5) (48.79) |
| Vaginal Fluid (collected by tear test strip) – Introïtus: |
| Ring 1 |
Cmax (µg /g) (±SD) (%CV) |
21.38 (± 10.54) (49.29) |
58.83 (± 145.8) (247.8) |
| |
tmax (h) * |
336.97 (24.12 – 674.98) |
24.17 (4.08 - 506.27) |
| |
AUC0-24h (µg.h/g) (±SD) (%CV) |
145.1 (± 128.7) (88.73) |
273.3 (± 124.5) (45.56) |
| |
AUC0-last (µg.h/g) (±SD) (%CV) |
7676 (± 3636) (47.37) |
21420 (± 40180) (187.6) |
| |
C24h (µg /g) (±SD) (%CV) |
9.98 (± 10.36) (103.8) |
16.19 (± 7.91) (48.86) |
| |
Cprior to ring removal (µg /g) (±SD) (%CV) |
10.33 (± 8.235) (79.90) |
9.881 (± 4.669) (47.26) |
| Ring 2 |
C0h (µg /g) (±SD) (%CV) |
0.2810 (± 0.4891) (252.3) |
BLQ |
| |
Cprior to ring removal (µg /g) (±SD) (%CV) |
9.168 (± 6.993) (76.28) |
8.327 (± 5.501) (66.07) |
| Ring 3 |
Cprior to ring removal (µg /g) (±SD) (%CV) |
– |
33.46 (± 48.42) (144.7) |
| |
AUC0-24h (µg.h/g) (±SD) (%CV) |
– |
503.5 (± 431.1) (85.62) |
| Vaginal fluid (collected by tear test strip) – Area near ring: |
| Ring 1 |
Cmax (µg /g) (±SD) (%CV) |
65.14 (± 29.83) (45.80) |
67.14 (± 26.84) (39.98) |
| |
tmax (h) * |
24.32 (4.22 - 671.77) |
168.12 (4.13 -506.87) |
| |
AUC0-24h (µg.h/g) (±SD) (%CV) |
951.7 (± 545.6) (57.33) |
1035 (± 378.7) (36.58) |
| |
AUC0-last (µg.h/g) (±SD) (%CV) |
28770 (± 14310) (49.72) |
31550 (± 12660) (40.12) |
| |
C24h (µg /g) (±SD) (%CV) |
53.92 (± 33.96) (62.98) |
53.86 (± 28.13) (52.23) |
| |
Cprior to ring removal (µg /g) (±SD) (%CV) |
32.41 (± 19.54) (60.30) |
20.25 (± 13.17) (65.04) |
| Ring 2 |
C0h (µg /g) (±SD) (%CV) |
0.8336 (± 2.103) (252.3) |
BLQ |
| |
Cprior to ring removal (µg /g) (±SD) (%CV) |
29.32 (± 16.65) (56.80) |
31.11 (± 19.62) (63.05) |
| Ring 3 |
Cprior to ring removal (µg /g) (±SD) (%CV) |
– |
55.41 (± 42.91) (77.44) |
| |
AUC0-24h (µg.h/g) (±SD) (%CV) |
– |
1307 (± 691.3) (52.90) |
