Table 3.
Model-predicted geometric mean (90% CI) dolutegravir (DTG) and tenofovir disoproxil fumarate (TFVTDF) concentrations in plasma and urine in healthy volunteers following drug intake cessation (1–3 missed doses)
| Number of missed doses (hours post-intake cessation) |
Threshold | ||||
|---|---|---|---|---|---|
| DTG | 1 (48) | 2 (72) | 3 (96) | MECplasma | PA-IC90 |
| Plasma, ng/mL | 348 (248–449) |
104 (60.8–146) |
34.1 (14.1–54.2) |
324 | 64.0 |
| Urine, ng/mL | 29.5 (5.50–53.5) |
8.77 (−2.73 to 20.3) |
2.89 (−2.68 to 8.46) |
27.4 (22.1–32.7) |
5.42 (4.37–6.46) |
| TFVTDF | 1 (48) | 2 (72) | 3 (96) | Urine concentration after 1 missed dose | |
| Plasma, ng/mL | 26.6 (23.1–30.1) |
11.8 (9.84–7.80) |
6.46 (5.12–7.80) |
6.20 (4.21–8.18) |
|
| Urine, ng/mL | 6441 (4340–8542) |
2859 (1850–3868) |
1565 (975–2155) |
1500 | |
Bold values indicate the threshold/cut-off concentrations; all other values are model-predicted.