Table 2B.
Steady State Emtricitabine Pharmacokinetic Summary by Analyte and Location
| Matrix | Analyte | FTC LLOQa | Arm 1 | Arm 2 | Arm 4 | Arm 7 | 
|---|---|---|---|---|---|---|
| Dose frequency | 1 tab 1×/wk | 1 tab 2×/wk | 2 tabs 2×/wk | 1 tab daily | ||
| Serumb | FTC | 0.31 ng/ml | 0.8 (0.4–0.9) | 5.4 (3.7–6.0) | 6.7 (5.4–7.6) | 70.9 (67.7–81.9) | 
| PBMC totalb | FTC-TP | 0.02 pmol/106 cells | 0.1 (0.1–0.1) | 0.4 (0.2–0.5) | 0.6 (0.5–0.6) | 2.2 (1.5–2.6) | 
| PBMC CD4+ onlyb | FTC-TP | 0.02 pmol/106 cells | 0.1 (0.1–1.7) | 0.5 (0.1–6.5) | 1.0 (0.3–6.9) | 3.2 (0.1–12.3) | 
| Colon homogenatec | FTC | 0.04 ng/mgd | 0.13 (BLQe–0.21) | 0.49 (0.20–2.08) | 1.22 (0.36–5.74) | 20.5 (1.87–49.32) | 
| Colon total cellsc | FTC-TP | 0.5 fmol/106 cells | BLQ (BLQ–BLQ) | BLQ (BLQ–1.2) | BLQ (BLQ–6.6) | BLQ (BLQ–0.14) | 
| Vagina homogenatec | FTC | 0.08 ng/mg | BLQ, BLQ | BLQ, BLQ, 0.38 | BLQ, 0.14 | 3.02, 3.31 | 
| Vagina total cellsc | FTC-TP | 0.5 fmol/106 cells | BLQ, BLQ | BLQ, BLQ | BLQ, BLQ | BLQ, BLQ | 
| Rectal fluidc | FTC | 5 ng/sponge | BLQ,BLQ | BLQ | BLQ | 20.8 | 
| Cervicovaginal fluidc | FTC | 20 ng/ml | 124 | BLQ, 182 | 143, 145 | 2330, 7420 | 
| Semenb | FTC | 5 ng/ml | BLQ, 7.4 | 21, 23 | 13, 27 | 907, 992 | 
LLOQ, lower limit of assay quantitation.
Median (range) of individual research participant medians at steady state (day 7–day 35).
Median (range) of day 35 concentrations; when three or fewer values are available, all values are shown without parentheses.
For tissue homogenates, values are reported as “per mg” based on conversion from “per sample” divided by sample weight. LLOQ per mg is based on median of sample weight and LLOQ per sample calculated for each sample.
BLQ, below limit of assay quantitation. (Note: sample mass varies greatly, especially for tissue and tissue cells, with substantial impact of true assay sensitivity.)
FTC, emtricitabine; FTC-TP, emtricitabine triphosphate.