TABLE 3

Summary of additional PK parameters based on actual sampling timesa

PK parameterDTG (n = 113)RPV (n = 113)
Test (DTG-RPV FDC tablet)Reference (DTG and RPV separate tablets)Test (DTG-RPV FDC tablet)Reference (DTG and RPV separate tablets)
Median (range) Tmax (h)3.02 (0.50, 6.00)3.00 (0.50, 8.00)4.00 (1.00, 9.00)4.00 (1.50, 9.00)
Geometric mean (95% CI) AUC0–24 (μg · h/ml)43.9 (42.3, 45.6)42.4 (40.9, 44.1)0.946 (0.885, 1.01)0.860 (0.806, 0.919)
Median (range) Tlag (h)0.00 (0.00, 1.03)0.00 (0.00, 1.00)0.50 (0.00, 2.50)0.50 (0.00, 2.57)
Geometric mean (95% CI) CL/F (liters/h)0.77 (0.74, 0.81)0.80 (0.76, 0.84)7.68 (7.12, 8.29)8.53 (7.88, 9.22)
Geometric mean (95% CI) t1/2 (h)14.5 (14.0, 15.1)14.8 (14.2, 15.3)51.7 (48.1, 55.7)52.5 (48.8, 56.5)
  • a AUC, area under the concentration-time curve; AUC0–24, AUC from time zero to 24 h; CI, confidence interval; CL/F, apparent oral clearance; Cmax, maximum concentration of drug in plasma; DTG, dolutegravir; FDC, fixed-dose combination; RPV, rilpivirine; t1/2, half-life; Tlag, absorption lag time; Tmax, time to Cmax.