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. 2022 Oct 21;25(Suppl 6):e26009. doi: 10.1002/jia2.26009
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.
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.