Table 3

Comparison of the Expected Darunavir PK Exposures for Different Regimens per Weight Group.

Weight Category/DoseMedian C0h (5th-95th percentile)Median AUC24h (5th-95th percentile)Median Cmax (5th-95th percentile)
ng/mLµg.h/mLng/mL
10 to 15 kg
 30 mg/kg q.d.2202 (1337 – 4002)77.2 (52.0 – 125)5692 (4529 – 7885)
 35 mg/kg q.d.a2570 (1560 – 4669)90 (60.6 – 146)6641 (5284 – 9199)
 40 mg/kg q.d.b2937 (1782 – 5336)103 (69.3 – 167)7590 (6039 – 10514)
 20 mg/kg b.i.d.c3270 (2035 – 5772)103 (69.3 – 167)5557 (4135 – 8234)
15 to 30 kg
 475 mg q.d.1947 (1049 – 4028)73.9 (50.0 – 129)5545 (4145 – 8224)
 550 mg q.d.2255 (1214 – 4664)85.5 (55.6 – 149)6420 (4800 – 9522)
 600 mg q.d.b2460 (1325 – 5088)93.3 (60.6 – 163)7004 (5236 – 10388)
 375 mg b.i.d.c3547 (2028 – 6944)117 (75.7 – 203)6222 (4335 – 10066)
30 to 40 kg
 600 mg q.d.1826 (1056 – 3556)74.5 (51.2 – 120)5642 (4455 – 7904)
 675 mg q.d.a2084 (1190 – 4000)83.8 (57.6 – 135)6347 (5012 – 8892)
 750 mg q.d.2316 (1322 – 4445)93.1 (64.0 – 150)7052 (5569 – 9880)
 800 mg q.d.b2470 (1410 – 4741)99.3 (68.3 – 160)7522 (5940 – 10539)
 450 mg b.i.d.c3329 (2018 – 6021)112 (76.8 – 180)5963 (4397 – 8932)
≥40 kg
 800 mg q.d.b1920 (1031 – 3948)81.1 (53.8 – 137)6066 (4615 – 8785)
 600 mg b.i.d.c3599 (2100 – 6831)122 (80.7 – 205)6426 (4559 – 10120)
Adult
 800 mg q.d.c2041 (911 – 4632)87.9 (60.5 – 143)6756 (1683)d
  • a FDA recommended q.d. regimens.

  • b Sponsor’s proposed q.d. regimens.

  • c Approved regimens.

  • d Mean (SD) based on the NCA.