sp;1.34
(1.12, 1.60)
PIB ↔ ↔ 1.26
(1.15, 1.37)
400 single
dose 300/120
single dose 11 GLE 4.51
(3.63, 6.05) 5.08
(4.11, 6.29) --
PIB ↔ 1.93
(1.78, 2.09) --
Darunavir
+ ritonavir 800 + 100
once daily 300/120
once daily 8 GLE 3.09
(2.26, 4.20) 4.97
(3.62, 6.84) 8.24
(4.40, 15.4)
PIB ↔ ↔ 1.66
(1.25, 2.21)
Elvitegravir/
cobicistat/
emtricitabine/
tenofovir
alafenamide 150/150/
200/10
once daily 300/120
once daily 11 GLE 2.50
(2.08, 3.00) 3.05
(2.55, 3.64) 4.58
(3.15,6.65)
PIB ↔ 1.57
(1.39, 1.76) 1.89
(1.63, 2.19)
Omeprazole 20 once
daily 300/120
single dose 9 GLE 0.78
(0.60, 1.00) 0.71
(0.58, 0.86) --
PIB ↔ ↔ --
40 once
daily (1 hour
before
GLE/PIB) 300/120
single dose 12 GLE 0.36
(0.21, 0.59) 0.49
(0.35, 0.68) --
PIB ↔ ↔ --
Rifampin 600 (first
dose) 300/120
single dose 12 GLE 6.52
(5.06, 8.41) 8.55
(7.01, 10.4) --
PIB ↔ ↔ --
600 once
daily 300/120
single doseb 12 GLE 0.14
(0.11, 0.19) 0.12
(0.09, 0.15) --
PIB 0.17
(0.14, 0.20) 0.13
(0.11, 0.15) --
Lopinavir/
ritonavir 400/100
twice daily 300/120
once daily 9 GLE 2.55
(1.84, 3.52) 4.38
(3.02, 6.36) 18.6
(10.4, 33.5)
PIB 1.40
(1.17, 1.67) 2.46
(2.07, 2.92) 5.24
(4.18, 6.58)
↔ = No change (central value ratio 0.80 to 1.25)
a. Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
b. Effect of rifampin on glecaprevir and pibrentasvir 24 hours after final rifampin dose.
Table 9. Drug Interactions: Pharmacokinetic Parameters for Coadministered Drug in the Presence of Combination of Glecaprevir/Pibrentasvir (GLE/PIB)
Co-
administered
Drug Regimen
of Co-
administered
Drug (mg) Regimen
of GLE/PIB
(mg) N Central Value Ratio (90% CI)
Cmax AUC Cmin
Abacavir ABC/DTG/3TC
600/50/300
once daily 300/120
once daily 12 ↔ ↔ 1.31
(1.05, 1.63)
Atorvastatin 10 once daily 400/120
once daily 11 22.0
(16.4, 29.6) 8.28
(6.06, 11.3) --
Caffeine 100 single dose 300/120
once daily 12 ↔ 1.35 (1.23, 1.48) --
Dabigatran Dabigatran
etexilate
150 single dose 300/120
once daily 11 2.05
(1.72, 2.44) 2.38
(2.11, 2.70) --
Darunavir DRV + RTV
800 + 100
once daily 300/120
once daily 12 1.30
(1.21, 1.40) 1.29
(1.18, 1.42) ↔
Ritonavir 2.03
(1.78, 2.32) 1.87
(1.74, 2.02) ↔
Dextro-
methorphan Dextromethorphan
hydrobromide 30
single dose 300/120
once daily 12 0.70
(0.61, 0.81) 0.75
(0.66, 0.85) --
Digoxin 0.5 single
dos |
