Table 2.
Mean (standard deviation) pharmacokinetic parameter values for the TFV IVR and TFV gela
| Parameter | Group 1 (IVR) |
Group 2 (gel) |
||||
|---|---|---|---|---|---|---|
| Proximal value | Distal value | Systemic value | Proximal value | Distal value | Systemic value | |
| Vaginal fluid | ||||||
| Tmaxb (h) | 504 | 72 | 336 | 8 | ||
| Cmax (ng/g) | 2.4E+7 (3.9) | 5.1E+6 (2.5) | 1.1E+6 (0.8) | 9.0E+5 (6.2) | ||
| AUC0-t (ng · h/g) | 1.3E+10 (2.2) | 2.4E+9 (2.2) | NA | NA | ||
| Vaginal tissue | ||||||
| Tmaxb (h) | 1.1E+3 | 2.2E+3 | 8 | 8 | ||
| Cmax (ng/g) | 4.7E+4 (2.6) | 8.8E+4 (9.7) | 2.7E+4 (2.8) | 8.1E+3 (11.2) | ||
| AUC0-t (ng · h/g) | 5.2E+7 (2.0) | 5.0E+7 (3.9) | NA | NA | ||
| Plasma | ||||||
| Tmaxb (h) | 336 | 2 | ||||
| Cmax (ng/ml) | 31.3 (8.3) | 46.8 (20.8) | ||||
| AUC0-t (ng · h/g) | 3.2E+4 (0.6) | NA | ||||
a
NA, not applicable.
b
Median Tmax reported. For the gel group, Tmax refers to the time following the 1st dose (336 h = pre-15th gel dose).