Table S1. Demographics of subjects across studiesa.
Study 1 Study 2 Study 3 Study 4 N 13 60 32 16 Female 62% 35% 45% 50% Age (yr) 33 (6) 29 (9) 34 (8) 33 (8) Ethnicity Hispanic
85%
13%
94%
75%
Weight (kg)
63.2 (12.8)
72.1 (12.7)
70.8 (10.9)
74.2 (12.5)
aData presented as mean (SD)
Table S2A. Pharmacokinetic parameters of elvitegravir (EVG) following multiple dose administration of elvitegravir/ritonavir (EVG/r) simultaneously with antacid (Study 1)a. Elvitegravir Parameter EVG/r EVG/r +
antacid GMR (%) (90% CI)
Cmax (ng/ml)
1370 (51.3) 716 (42.2) 53.1 (46.8, 60.2)
AUCtau (ng.hr/ml)
15600 (48.9) 9510 (50.4) 55.1 (50.4, 60.2)
Ctau (ng/ml)
341 (38.8) 219 (66.0)
59.1 (52.0, 67.2)
Tmax (hours)
4.0 (4.0, 5.0) 4.0 (4.0, 4.0) NA
T1/2 (hours)
9.4 (7.9, 12.2) 11.0 (7.2, 12.4)
a Data presented using 3 significant figures and as arithmetic mean (% coefficient of variation); Tmax and T1/2 as median (first quartile, third quartile). GMR indicates geometric mean ratio (90% confidence interval); NA: not applicable
Table S2B. Summary and Statistical Comparisons of the Effect of Famotidine (co-administered or +12 hours) on COBI and EVG Pharmacokinetic Parameters (Studies 3 and 4)a
COBI-boosted EVG + Famotidine
(+12 hours) n=10
COBI-boosted EVG + Famotidine (coadministered)
n=16
Reference-Treatment
A Mean
(%CV)
Test - Treatment
D Mean
(%CV)
GLS Means
Ratio as %
(90%CI)
Reference-Treatment
A Mean
(%CV)
Test - Treatment
E Mean
(%CV)
GLS Means
Ratio as %
(90%CI)
COBI
AUCtau (ng·h/mL)
12,300 (51.3)
12,700 (45.1)
105 (102, 108)
10,000 (19.9)
10,500 (24.2)
103 (96.8, 111)
Cmax (ng/ml)
1,730 (37.2)
1,770 (30.5)
104 (99.1, 108)
1,530 (20.7)
1,630 (21.7)
106 (99.4, 113)
Ctau (ng/ml)
35.3 (140)
39.3 (131)
115 (106, 126)
22.1 (72.7)
25.7 (78.4)
111 (99.8, 124)
EVG
AUCtau (ng·h/mL)
22,700 (18.9)
23,500 (20.4)
103 (94.9, 113)
24,000 (15.8)
24,900 (20.6)
103 (98.1, 108)
Cmax (ng/ml)
2,140 (23.0)
2,200 (23.6)
102 (89.4, 117)
2,240 (26.2)
2,270 (28.6)
100 (91.7, 110)
Ctau (ng/ml)
441 (33.5)
526 (37.1)
118 (105, 132)
420 (32.1)
458 (38.5)
107 (98.4, 117)
a Data presented using 3 significant figures and as arithmetic mean (% coefficient of variation); GMR indicates geometric mean ratio (90% confidence interval)
Figure S1A.
Figure S1B.
