Table 3.
Vaginal fluid TFV concentrations (ng/mg) and vaginal tissue TFV (ng/mg) and TFV-DP (fmol/mg) concentrations among TFV/LNG IVR users (cyclic and continuous cohorts combined) with either Lactobacillus dominated (LbD) or CST IVA/B microbiota.
| Visit | LbD microbiota | CST IVA/B microbiota | p value | ||||||
|---|---|---|---|---|---|---|---|---|---|
| N | Mean | SD | Median | N | Mean | SD | Median | ||
| TFV in vaginal fluid (ng/mg) | |||||||||
| Month 1 | 15 | 1,577 | 823 | 1,502 | 16 | 3,981 | 3,337 | 3,135 | 0.02 |
| Month 2 | 14 | 1,524 | 1,287 | 1,364 | 16 | 5,926 | 6,345 | 3,800 | <0.01 |
| Month 3 | 12 | 1,647 | 607 | 1,423 | 18 | 1,463 | 2,696 | 351 | 0.02 |
| TFV in vaginal tissue (ng/mg) | |||||||||
| 24 h post IVR insertion | 5 | 40.99 | 52.39 | 25.6 | 7 | 21.22 | 18.11 | 13.72 | 0.87 |
| 48 h post IVR insertion | 7 | 52.9 | 55.31 | 25.81 | 4 | 19.53 | 16.41 | 18.13 | 0.64 |
| 72 h post IVR insertion | 6 | 184.51 | 191.99 | 130.3 | 7 | 42.88 | 48.83 | 23.32 | 0.87 |
| Month 3 | 11 | 189 | 217 | 103 | 19 | 60 | 144 | 5 | < 0.01 |
| TFV-DP in vaginal tissue (fmol/mg) | |||||||||
| 24 h post IVR insertion | 5 | 408.42 | 393.73 | 436.83 | 7 | 265.78 | 277.7 | 192.57 | 0.63 |
| 48 h post IVR insertion | 7 | 1,936.04 | 2,621.49 | 775.32 | 4 | 167.05 | 102.41 | 151.76 | <0.05 |
| 72 h post IVR insertion | 6 | 5,566.12 | 6,319.33 | 2,833.98 | 7 | 4,124.73 | 6,846.32 | 2,039.38 | 0.63 |
| Month 3 | 11 | 15,491.9 | 21,133.3 | 5,877.7 | 19 | 1,457.67 | 2,599.59 | 212.38 | <0.01 |