Table B. Raltegravir Pharmacokinetic Parameters for Raltegravir-Naive and Raltegravir-Exposed Neonates

Table B. Raltegravir Pharmacokinetic Parameters for Raltegravir-Naive and Raltegravir-Exposed Neonates
PK Parameter	Initial Dose: RAL 1.5 mg/kg Once Daily RAL-Naive (n = 25)^d	Initial Dose: RAL 1.5 mg/kg Once Daily RAL-Exposed (n = 10)	Days 15–18: RAL 3.0 mg/kg Twice Daily RAL-Naive (n = 24)^e	Days 15–18: RAL 3.0 mg/kg Twice Daily RAL-Exposed (n = 10)^f
PK Parameter	GM (CV%)	GM (CV%)	GM (CV%)	GM (CV%)
AUC_0–24h (mg·h/L)^a	38.2 (42.0%)	42.9 (25.3%)	_	_
AUC_0–12h (mg·h/L)	_	_	14.3 (49.5%)	18.3 (62.8%)
C_trough(ng/mL)^b	948 (84.0%)	946 (74.0%)	176 (162.1%)	274 (176.4%)
C_max (ng/mL)^c	2,350 (36.5%)	2,565 (23.1%)	2,849 (47.5%)	3,667 (46.3%)
T_max (hours)	5.4 (71.5%)	3.8 (88.8%)	2.3 (77.1%)	1.9 (52.3%)
T_1/2 (hours)	15.8 (101.4%)	14.4 (69.5%)	2.5 (34.1%)	2.9 (20.7%)
^a AUC targets: AUC_0–24h 12–40 mg·h/L and AUC_0–12h 6–20 mg·h/L. ^b C_trough concentration >33 ng/mL. For initial dose, C_last collected at 24 hours was used. For Days 15–18, C_12h was estimated when the 12 hours post-dose sample was collected earlier than 12 hours after dosing (the protocol specified a sample collection time of 8–12 hours post dose). ^c C_max <8,724 ng/mL ^d AUC_0–24h could not be estimated for one infant. ^e AUC_0–12h and C_trough could not be estimated for one infant with delayed absorption. ^f AUC_0–12h and C_max could not be estimated for one infant with incomplete sample collection.