Table 4.
Summary of simulated steady state PK parameters by weight band for ABC/DTG/3TC FDC dosing
| Weight bands | Proposed daily dose |
Cmax (µg/ml) |
AUC0–24 (µg*h/ml) |
C24 (µg/ml) |
|---|---|---|---|---|
| ABC | ||||
| ≥ 6 to < 10 kg | 180 mg DT | 6.63 (2.84–14.96) | 17.36 (6.66–43.70) | 0.039 (0.003–0.344) |
| ≥ 10 to < 14 kg | 240 mg DT | 6.66 (2.85–15.04) | 16.66 (6.43–41.62) | 0.027 (0.003–0.246) |
| ≥ 14 to < 20 kg | 300 mg DT | 6.41 (2.71–14.71) | 15.47 (5.94–39.12) | 0.020 (0.003–0.178) |
| ≥ 20 to < 25 kg | 360 mg DT | 6.31 (2.65–14.43) | 14.89 (5.72–37.49) | 0.016 (0.003–0.138) |
| ≥ 25 kg to < 40 kg | 600 mg tablet | 8.06 (3.31–18.85) | 18.50 (7.00–47.70) | 0.014 (0.003–0.136) |
| DTG | ||||
| ≥ 6 to < 10 kg | 15 mg DT | 6.99 (3.83–13.05) | 70.55 (30.5–166.4) | 0.94 (0.13–4.60) |
| ≥ 10 to < 14 kg | 20 mg DT | 6.88 (3.90–12.13) | 65.36 (29.69–142.6) | 0.74 (0.10–3.54) |
| ≥ 14 to < 20 kg | 25 mg DT | 7.12 (4.03–12.59) | 68.57 (31.33–150.4) | 0.81 (0.11–3.78) |
| ≥ 20 to < 25 kg | 30 mg DT | 7.42 (4.21–13.15) | 72.36 (33.03–158.3) | 0.88 (0.13–4.03) |
| ≥ 25 kg to < 40 kg | 50 mg tablet | 6.24 (3.41–11.38) | 66.75 (30.49–146.1) | 0.95 (0.15–4.11) |
| 3TC | ||||
| ≥ 6 to < 10 kg | 90 mg DT | 2.83 (1.43–5.48) | 11.57 (5.82–22.36) | 0.012 (0.003–0.132) |
| ≥ 10 to < 14 kg | 120 mg DT | 2.84 (1.45–5.44) | 11.40 (5.79–21.66) | 0.0118 (0.003–0.127) |
| ≥ 14 to < 20 kg | 150 mg DT | 2.74 (1.39–5.28) | 10.78 (5.49–20.6) | 0.0114 (0.003–0.121) |
| ≥ 20 to < 25 kg | 180 mg DT | 2.70 (1.37–5.20) | 10.50 (5.34–19.96) | 0.0112 (0.003–0.119) |
| ≥ 25 kg to < 40 kg | 300 mg tablet | 3.48 (1.73–6.80) | 13.20 (6.59–25.65) | 0.0115 (0.003–0.125) |
AUC0–24, Cmax and C24 presented as a GM (90% prediction interval). The GM C24 target range for DTG was 0.697–2.26 µg/ml, and the target GM AUC0–24 was 37–134 µg*h/ml. For ABC, the GM AUC0–24 target range was 6.3–50.4 µg*h/'ml, and the 3TC GM AUC0–24 target range was 6.3–26.5 µg*h/ml