Table 4: Tenofovir alafenamide fumarate (Table sourced from Genvoya; Submission) Species Study Sex Study TFV AUCss TAF TFV/TAF duration dose 0–24h exposure AUCss drug ng∙h/mL ng∙h/mL Mouse 13 Combined 10 213 NC 0.72/NC (CD1) (TAF) 30 1507 NC 5.14/NC 100 7397 NC 25.24/NC 2 years Males 600 44,300 NA 151.19/NA (TDF) Females 50,900 NA 173.72/NA Rat 6 months Males 5 740 NA 2.52 (TAF) (SD) 25 3530 NA 12.05 100 15,930 NA 54.37 Females 5 600 NA 2.05 25 4000 NA 13.65 100 15,140 NA 51.67 2 Males 10/ 16,690 NA 56.96/NA (TDF) 300 30 2700 NA 9.22/NA 100 6600 NA 22.53/NA Females 10/ 15,720 NA 53.65/NA 300 30 3060 NA 10.44/NA 100 7460 NA 25.46/NA Dog 9 months Males 2 1300 90 4.44/0.44 (Beagle) (TAF) 6 3890 1290 6.25/6.26 18/12 14,900 2160 13.28/10.48 2 1070 Females 60 3.65/0.29 6 5010 780 17.10/3.79
Table 4: Tenofovir alafenamide fumarate (Table sourced from Genvoya; Submission) Species Study duration drug Sex Study dose TFV AUCss 0–24h ng∙h/mL TAF AUCss ng∙h/mL TFV/TAF exposure Mouse (CD1) 13 (TAF) Combined 10 213 NC 0.72/NC 30 1507 NC 5.14/NC 100 7397 NC 25.24/NC 2 years (TDF) Males 600 44,300 NA 151.19/NA Females 50,900 NA 173.72/NA Rat (SD) 6 months (TAF) Males 5 740 NA 2.52 25 3530 NA 12.05 100 15,930 NA 54.37 Females 5 600 NA 2.05 25 4000 NA 13.65 100 15,140 NA 51.67 2 (TDF) Males 10/ 300 16,690 NA 56.96/NA 30 2700 NA 9.22/NA 100 6600 NA 22.53/NA Females 10/ 300 15,720 NA 53.65/NA 30 3060 NA 10.44/NA 100 7460 NA 25.46/NA Dog (Beagle) 9 months (TAF) Males 2 1300 90 4.44/0.44 6 3890 1290 6.25/6.26 18/12 14,900 2160 13.28/10.48 Females 2 1070 60 3.65/0.29 6 5010 780 17.10/3.79
auspar-emtricitabine-161220.docx