Abstract P211 – Table 1. Statistical analysis summary of darunavir, cobicistat, emtricitabine, and TAF after oral administration of a paediatric formulation of D/C/F/TAF FDC versus coadministration of separate commercial agents. | ||||||
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Parameter | DRV + COBI + FTC/TAF (reference) N | D/C/F/TAF (test) N | GMR | 90% CI | Intra‐individual CV (%) of reference | Intra‐individual CV (%) of test |
Darunavir | ||||||
Cmax (ng/mL) | 32 | 32 | 0.98 | 0.94 to 1.02 | 10.3 | 13.2 |
AUClast (ng.h/mL) | 32 | 32 | 1.03 | 0.98 to 1.08 | 9.6 | 9.5 |
Cobicistat | ||||||
Cmax (ng/mL) | 32 | 32 | 0.94 | 0.90 to 0.98 | 14.2 | 14.5 |
AUClast (ng.h/mL) | 32 | 32 | 0.97 | 0.93 to 1.02 | 11.0 | 10.7 |
Emtricitabine | ||||||
Cmax (ng/mL) | 32 | 32 | 0.99 | 0.94 to 1.04 | 17.6 | 17.6 |
AUClast (ng.h/mL) | 32 | 32 | 1.01 | 0.99 to 1.02 | 6.3 | 5.8 |
TAF | ||||||
Cmax (ng/mL) | 32 | 32 | 1.05 | 0.91 to 1.22 | 56.9 | 49.3 |
AUClast (ng.h/mL) | 32 | 32 | 1.13 | 1.07 to 1.20 | 23.1 | 14.8 |
COBI, cobicistat; CV, coefficients of variation; DRV, darunavir; FTC, emtricitabine.