Table 2.
Plasma Tenofovir Pharmacokinetic Parameters by Product; Median (25th Percentile, 75th Percentile)
| RF | RGVF | VF | p-value RGVF vs. RF | p-value VF vs. RF | p-value VF vs. RGVF | |
|---|---|---|---|---|---|---|
| Cmax (ng/ml)a | ||||||
| No SURAI | 3.65 (1.35, 4.55) | 5.95 (5.07, 7.99) | 23.3 (12.93–30.6) | 0.035 | 0.009 | 0.06 |
| SURAI | 12.4 (3.1, 31.7) | 6.87 (3.71, 23.5) | 36.45 (22.75–65.8) | 0.53 | 0.093 | 0.03 |
| Tmax (h)a | ||||||
| No SURAI | 2.85 (1.89, 6.23) | 1.03 (0.95, 2.53) | 1.18 (0.92, 1.23) | 0.07 | 0.005 | 0.67 |
| SURAI | 1.65 (1.54, 5.63) | 1.53 (1.5, 1.64) | 1.26 (0.8, 1.54) | 0.19 | 0.016 | 0.1 |
| AUC0–24a (ng · h/ml) | ||||||
| No SURAI | 30.13 (14.9, 55) | 39.17 (19.1, 57.4) | 81.64 (48.8, 137.1) | 0.67 | 0.09 | 0.14 |
| SURAI | 46.51 (20.8, 71) | 23.13 (19, 53.5) | 87.83 (73.5, 122.5) | 0.46 | 0.09 | 0.027 |
a
Comparison of SURAI vs. no SURAI for each PK parameter yielded p-value > 0.05.
SURAI, simulated unprotected receptive anal intercourse.