Table 3:

Week 2 AUC₂₄, log₁₀C_max, log₁₀C_min and log₁₀ Clearance. Mean differences by UGT1A1 variants Model 1 using the normal metabolism as the reference. Model 2 uses normal and intermediate as reference. Adjustment variables included drug formulation cohort, weight, and sex.

							Regression Model
				Unadjusted			Adjusted
Genotype	PK Parameter	Gene Levels	n	Mean Difference	CI	P-value	Mean Difference	CI	P-value
UGT1A1	AUC24(μg*h/mL)	Normal	38
Model 1		Intermediate	15	−15.83	(−30.01, −1.64)	0.029	−18.52	(−34.23, −2.81)	0.021
		Poor	5	7.49	(−14.65, 29.63)	0.51	9.48	(−13.68, 32.64)	0.42
	Cmax(μg/mL)	Normal	38
		Intermediate	15	−0.13	(−0.22, −0.04)	0.004	−0.14	(−0.24, −0.04)	0.005
		Poor	5	0.04	(−0.10, 0.17)	0.60	0.05	(−0.09, 0.20)	0.48
	Cmin(μg/mL)	Normal	38
		Intermediate	15	−0.18	(−0.36, −0.00)	0.047	−0.19	(−0.38, −0.00)	0.045
		Poor	5	0.18	(−0.10, 0.46)	0.21	0.14	(−0.13, 0.42)	0.31
	log Clearance (L/hr)	Normal	38
		Intermediate	16	0.06	(−0.12, 0.25)	0.52	0.08	(−0.05, 0.20)	0.23
		Poor	5	0.03	(−0.27, 0.32)	0.85	−0.13	(−0.31, 0.06)	0.19
Model 2	AUC24(μg*h/mL)	Normal/Intermediate	53
		Poor	5	11.97	(−10.68, 34.62)	0.30	11.84	(−12.27, 35.95)	0.34
	Cmax(μg/mL)	Normal/Intermediate	53
		Poor	5	0.07	(−0.07, 0.22)	0.32	0.07	(−0.08, 0.22)	0.37
	Cmin(μg/mL)	Normal/Intermediate	53
		Poor	5	0.23	(−0.06, 0.52)	0.11	0.17	(−0.12, 0.45)	0.25
	log Clearance (L/hr)	Normal/Intermediate	54
		Poor	5	0.01	(−0.28, 0.30)	0.95	−0.13	(−0.32, 0.06)	0.16