Table 3.
Tenofovir (TFV) and emtricitabine (FTC) non-compartmental PK parameters of participants of the PrEParadas DDI substudy according to FHT use and period of evaluation
| Parameter | Short-term PK | Long-term PK | |||||
|---|---|---|---|---|---|---|---|
| noFHTa (n = 12) GM (95% CI) |
sFHTb (n = 18) GM (95% CI) |
GMRc (95% CI) |
P valued | aFHTe (n = 13) GM (95% CI) |
GMRf (95% CI) |
P valueg | |
| TFV AUC0–24 (ng·h/mL) | 2136.27 (1831.41–2491.87) | 2392.38 (2109.75–2712.87) | 1.12 (0.92–1.37) | 0.25 | 2160.80 (1858.14–2512.74) | 1.01(0.82–1.24) | 0.91 |
| TFV Cmax (ng/mL) | 247.86(208.92–294.05) | 299.60(260.58–344.46) | 1.21(0.97-1.51) | 0.09 | 269.15(229.50–315.65) | 1.09(0.85–1.38) | 0.49 |
| TFV Tmax (h) | 0.94(0.76–1.17) | 0.89(0.75–1.06) | 0.94(0.72–1.24) | 0.67 | 1.00(0.74–1.34) | 1.06(0.71–1.57) | 0.76 |
| TFV CL/F (L/h) | 140.43(120.39–163.81) | 125.40(110.58–142.20) | 0.89(0.73–1.09) | 0.25 | 138.84(119.39–161.45) | 0.99(0.80-1.22) | 0.91 |
| TFV V/F (L) | 2778.20(2309.96–3341.36) | 2503.86(2153.58 - 2911.12) | 0.90(0.71–1.14) | 0.38 | 2872.17(2398.88–3438.85) | 1.03(0.78–1.36) | 0.80 |
| TFV Cmin (ng/mL) | 39.41(33.44–46.44) | 43.13(37.72–49.32) | 1.09(0.89–1.35) | 0.39 | 40.70(34.08–48.60) | 1.03(0.84–1.27) | 0.75 |
| TFV lambda (h−1) | 0.05(0.045–0.057) | 0.05(0.046–0.056) | 1.00(0.86–1.17) | 0.97 | 0.049(0.044–0.055) | 0.98(0.82–1.17) | 0.82 |
| FTC AUC0–24 (ng·h/mL) | 9693.51(8761.14–10725.11) | 10980.78(10110.49–11925.99) | 1.13(0.99–1.29) | 0.06 | 9512.94(8200.43–11035.53) | 0.98(0.82–1.17) | 0.83 |
| FTC Cmax (ng/mL) | 1656.00(1489.67–1840.90) | 1911.02(1752.79–2083.54) | 1.15(1.01–1.32) | 0.04 | 1848.62(1642.59–2080.49) | 1.12(0.96–1.30) | 0.15 |
| FTC Tmax (h) | 1.50(1.22–1.84) | 1.59(1.34–1.87) | 1.06(0.81–1.38) | 0.66 | 1.30(1.06–1.61) | 0.87(0.65–1.17) | 0.34 |
| FTC CL/F (L/h) | 20.63(18.23–22.83) | 18.21(16.77–19.78) | 0.88(0.77–1.01) | 0.06 | 21.02(18.12–24.39) | 1.02(0.86–1.21) | 0.83 |
| FTC V/F (L) | 192.30(163.26–226.51) | 167.55(146.58–191.51) | 0.87(0.71–1.08) | 0.19 | 205.78(163.45–259.07) | 1.07(0.81–1.42) | 0.63 |
| FTC Cmin (ng/mL) | 63.39(53.20–75.52) | 66.41(57.56–76.62) | 1.05(0.84–1.31) | 0.68 | 60.97(49.66–74.85) | 0.96(0.76–1.22) | 0.74 |
| FTC lambda (h−1) | 0.11(0.10–0.12) | 0.11(0.10–0.12) | 1.01(0.89–1.14) | 0.86 | 0.10(0.09–0.12) | 0.96(0.82–1.10) | 0.44 |
GM, geometric mean; GMR, geometric mean ratio. Bold type indicates statistical significance.
a
On PrEP only (n = 12).
b
On PrEP plus standardized FHT (n = 18).
c
sFHT (short-term PK)/noFHT (short-term PK) GMR.
d
t-test comparing noFHT versus sFHT participants.
e
On PrEP plus any oestradiol-based FHT (n = 13).
f
aFHT (long-term PK)/noFHT (short-term PK) GMR.
g
t-test comparing noFHT (short-term PK) versus aFHT (long-term PK) participants.