TABLE 2

Statistical analysis of log-transformed DTG and RPV PK parametersc

Analyte and PK parameterAdjusted geometric mean (n) with the following treatment:Test treatment/reference treatment ratio (90% CI)
Test (DTG-RPV FDC tablet)Reference (DTG and RPV separate tablets)
DTG
    AUC0–∞ (μg · h/ml)64.968 (113)62.655 (113)1.037 (1.010, 1.064)
    AUC0–t (μg · h/ml)63.583 (113)61.265 (113)1.038 (1.011, 1.066)
    Cmax (μg/ml)3.646 (113)3.474 (113)1.050 (1.022, 1.078)
    C24a1.001 (112)0.958 (112)1.044 (1.012, 1.077)
RPV
    AUC0–∞ (μg · h/ml)b3.248 (112)2.933 (112)1.108 (1.045, 1.174)
    AUC0–t (μg · h/ml)3.062 (113)2.767 (113)1.107 (1.042, 1.176)
    Cmax (μg/ml)0.093 (113)0.083 (113)1.124 (1.047, 1.207)
    C240.031 (113)0.028 (113)1.101 (1.034, 1.173)
  • a Paired data only; 1 participant was excluded because of a missing result in period 2.

  • b Paired data only; 1 participant was excluded because in period 1 the percentage of AUC0–∞ that was extrapolated was >20%, R2 was <0.85 in estimation of the terminal-phase rate constant, and the range of time over which the half-life (t1/2) was calculated was <2 × t1/2.

  • c AUC, area under the concentration-time curve; AUC0–t, AUC from 0 h to the last quantifiable measurement; AUC0–∞, AUC from 0 h to infinity; C24, plasma concentration at 24 h postdose; CI, confidence interval; Cmax, maximum concentration of drug in plasma; DTG, dolutegravir; FDC, fixed-dose combination; RPV, rilpivirine; n, number of participants.