Table 3.
Concentrations of EVG, TAF and TFV (ng/mL) in vaginal fluid.
| Analyte | Visit | Statistical Measures * | Group 1 4 hours at Visit 3 and 48 hours at Visit 4 (N=8) |
Group 2 24 hours at Visit 3 and 72 hours at Visit 4 (N=8) |
|---|---|---|---|---|
| EVG (ng/mL) vaginal fluid |
Visit 3 | n | 8 | 7 |
| Mean (SD) | 2,201,502 (1,741,831) | 323,378 (278,363) | ||
| Median (Q1, Q3) | 1,507,362 (1,054,818, 2,802,391) | 177,765 (95,935, 649,951) | ||
| Number (%) with BLQ | 0 (0.0%) | 0 (0.0%) | ||
| Visit 4 | n | 8 | 7 | |
| Mean (SD) | 25,668 (14,044) | 31,204 (52,647) | ||
| Median (Q1, Q3) | 26,090 (16,037, 33,252) | 4,816 (1,535, 65,403) | ||
| Number (%) with BLQ | 0 (0.0%) | 0 (0.0%) | ||
| Visit 5 | n | 8 | 8 | |
| [7 days post-dose] | Mean (SD) | 923 (1,915) | 1,804 (2,453) | |
| Median (Q1, Q3) | 199 (37, 657) | 376 (38, 3,556) | ||
| Number (%) with BLQ | 0 (0.0%) | 1 (12.5%) | ||
| TAF (ng/mL) vaginal fluid |
Visit 3 | n | 8 | 7 |
| Mean (SD) | 3,662,350 (4,966,790) | 368,539 (251,283) | ||
| Median (Q1, Q3) | 2,319,007 (1,267,333, 3,249,263) | 340,854 (232,508, 474,736) | ||
| Number (%) with BLQ | 0 (0.0%) | 0 (0.0%) | ||
| Visit 4 | n | 8 | 7 | |
| Mean (SD) | 12,471 (15,094) | 5,380 (6,788) | ||
| Median (Q1, Q3) | 4,278 (122, 27,786) | 953 (16, 13,608) | ||
| Number (%) with BLQ | 0 (0.0%) | 1 (14.3%) | ||
| Visit 5 | n | 8 | 8 | |
| [7 days post-dose] | Mean (SD) | 10 (17) | 22 (51) | |
| Median (Q1, Q3) | 0.76 (0.01, 19.06) | 0.79 (0.01, 13.50) | ||
| Number (%) with BLQ | 4 (50.0%) | 3 (37.5%) | ||
| TFV (ng/mL) vaginal fluid |
Visit 3 | n | 8 | 7 |
| Mean (SD) | 241,795 (155,893) | 227,198 (174,859) | ||
| Median (Q1, Q3) | 227,644 (142,779, 332,234) | 210,543 (60,496, 342,268) | ||
| Number (%) with BLQ | 0 (0.0%) | 0 (0.0%) | ||
| Visit 4 | n | 8 | 7 | |
| Mean (SD) | 28,511 (19,961) | 21,674 (18,390) | ||
| Median (Q1, Q3) | 19,961 (14,608, 37,790) | 17,098 (9,004, 28,946) | ||
| Number (%) with BLQ | 0 (0.0%) | 0 (0.0%) | ||
| Visit 5: | n | 8 | 8 | |
| [7 days post-dose] | Mean (SD) | 4,353 (3,645) | 2,919 (2,386) | |
| Median (Q1, Q3) | 3,592 (2,484, 4,668) | 2,651 (1,052, 4,059) | ||
| Number (%) with BLQ | 0 (0.0%) | 0 (0.0%) |
*Means and Medians do not include BLQ values.