Table 2:
NFV PK Comparison of 3rd Trimester vs. Postpartum (N=16) – Table 2 describes the pharmacokinetics of NFV during the 3rd trimester, compared to postpartum.
| Parameter | 3rd trimester: median (IQR) (n = 18) 1875mg BID |
Postpartum: median (IQR) (n=16) 1250mg BID |
Geometric mean ratio 3rd
trimester/ postpartum (90% CI) |
P-value* |
|---|---|---|---|---|
| NFV AUC0–12 μg-h/mL [μM-h] |
34.2 (27.2–46.9) [60.2 (47.9–82.6)] |
33.5 (28.6–43.5) [58.9 (50.3–76.6)] |
0.98 (0.71–1.35) |
0.78 |
| NFV Cmin (μg/mL) | 0.47 (0.35–1.33) | 0.52 (0.22–0.80) | 0.90 (0.71–1.16) | 0.49 |
| NFV Cmax (μg/mL) | 5.1 (4.3–6.5) | 5.0 (4.2–5.9) | 1.06 (0.85–1.34) | 0.67 |
| NFV Cl/F (L/h) | 54.9 (40.4–68.9) | 37.4 (28.7–43.7) | 1.54 (1.12–2.11) | 0.04 |
*
p-value for Wilcoxon rank-sum test; IQR = interquartile range, BID = twice daily, AUC0–12 = area under concentration vs time curve (0 to 12 hours post-dose), Cl/F = molar clearance, Cmin= minimum concentration, Cmax= maximum concentration, CI = confidence interval.