Table 3.
Population pharmacokinetic parameters of tenofovir from the final model for 36 HIV-infected pregnant women after receiving 600 mg of TDF at the onset of labor and for their 36 neonates enrolled in the TEmAA ANRS 12109 Trial, Step 2a
| Structural model parameter | Estimate by structural model (% RSE) | Statistical model |
|
|---|---|---|---|
| Parameter | Estimate (% RSE) | ||
| ka | 0.651 h−1 (13) | ωCL/F | 39% (22) |
| CL/F | 189 liters/h (11) | ωV1/F | 165% (13) |
| V1/F | 482 liters (34) | ωQ/F | 63% (19) |
| Q/F | 230 liters/h (16) | ||
| V2/F | 3,500 liters (23) | ωkan | 177% (15) |
| k1F | 0.259 h−1 (38) | ωCLn/F | 68% (9) |
| kF1 | 0.691 h−1 (31) | ωVn/F | 46% (18) |
| kFC | 0.157 h−1 (49) | σmother plasma | 0.03 mg · liter−1 (4) |
| km | 0.0495 h−1 (29) | σcord plasma | 0.014 mg · liter−1 (12) |
| kem | 0.005 h−1 (fixed) | σneonate plasma | 47% (12) |
| kan | 0.518 h−1 (38) | σcord TFV cells | 63.2 fmol/106 cells (16) |
| CLn/F | 3.01 liters/h (13) | σneonate TFV cells | 105% (16) |
| Vn/F | 37.7 liters (17) | σcord TFV-DP cells | 33.4 fmol/106 cells (16) |
| Vn/F, θGA | 8.5 (32) | σneonate TFV-DP cells | 114% (16) |
RSE, relative standard error (standard error of estimate/estimate · 100); ka, absorption rate constant; CL/F, maternal apparent elimination clearance from the central compartment; V1/F, apparent volume of distribution of the central maternal compartment; Q/F, apparent maternal intercompartmental clearance; V2/F, apparent volume of distribution of the peripheral maternal compartment; k1F, maternal-to-fetal rate constant; kF1, fetal-to-maternal rate constant; kFC, fetal-to-cord rate constant; kan, neonatal absorption; CLn/F, neonatal apparent elimination clearance; Vn/F, apparent neonatal volume of distribution; Vn/F, θGA, influential factor for gestational age on neonatal apparent volume of distribution; km, TFV-to-intracellular TFV-DP metabolism constant rate; kem, TFV-DP elimination constant rate; σ, residual variability estimates (CV of residual variability [%]); and ω, interindividual variability estimates (CV of intersubject variability [%]).