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VIEKIRA XR(dasabuvir, ombitasvir, paritaprevir, and ritonavir)extended-release tablets(二十)
ively, while ombitasvir AUC values were unchanged in subjects with mild renal impairment.
Relative to subjects with normal renal function, dasabuvir, paritaprevir, and ritonavir AUC values increased by 37%, 33%, and 80% respectively, while ombitasvir AUC values were unchanged in subjects with moderate renal impairment.
Relative to subjects with normal renal function, dasabuvir, paritaprevir, and ritonavir AUC values increased by 50%, 45%, and 114% respectively, while ombitasvir AUC values were unchanged in subjects with severe renal impairment [see Use in Specific Populations (8.7)].
Drug Interaction Studies
See also Contraindications (4), Warnings and Precautions (5.5), Drug Interactions (7)
All drug-drug interaction trials were conducted with VIEKIRA PAK. The effects of some drugs discussed in TABLE 5 on the exposures of dasabuvir, ombitasvir, paritaprevir, and ritonavir are shown in TABLE 7. For information regarding clinical recommendations, see Drug Interactions (7).
Table 7. Drug Interactions: Change in Pharmacokinetic Parameters of Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir in the Presence of Co-administered Drug
Co-administered
Drug Dose of Co-
administered
Drug (mg) n DAA Ratio (with/without co-administered drug)
of DAA Pharmacokinetic Parameters
(90% CI);
No Effect = 1.00
Cmax AUC Cmin
Alprazolam 0.5 single
dose 12 dasabuvir 0.93
(0.83, 1.04) 0.98
(0.87, 1.11) 1.00
(0.87, 1.15)
ombitasvir 0.98
(0.93, 1.04) 1.00
(0.96, 1.04) 0.98
(0.93, 1.04)
paritaprevir 0.91
(0.64, 1.31) 0.96
(0.73, 1.27) 1.12
(1.02, 1.23)
ritonavir 0.92
(0.84, 1.02) 0.96
(0.89, 1.03) 1.01
(0.94, 1.09)
Amlodipine 5 single dose 14 dasabuvir 1.05
(0.97, 1.14) 1.01
(0.96, 1.06) 0.95
(0.89, 1.01)
ombitasvir 1.00
(0.95, 1.06) 1.00
(0.97, 1.04) 1.00
(0.97, 1.04)
paritaprevir 0.77
(0.64, 0.94) 0.78
(0.68, 0.88) 0.88
(0.80, 0.95)
ritonavir 0.96
(0.87, 1.06) 0.93
(0.89, 0.98) 0.95
(0.89, 1.01)
Atazanavir/
ritonavira Atazanavir 300
and ritonavir 100
once daily in the evening 11 dasabuvir 0.81
(0.73, 0.91) 0.81
(0.71, 0.92) 0.80
(0.65, 0.98)
ombitasvir 0.83
(0.72, 0.96) 0.90
(0.78, 1.02) 1.00
(0.89, 1.13)
paritaprevir 2.19
(1.61, 2.98) 3.16
(2.40, 4.17) 11.95
(8.94, 15.98)
ritonavir 1.60
(1.38, 1.86) 3.18
(2.74, 3.69) 24.65
(18.64, 32.60)
Carbamazepine 200 once daily
followed by
200 twice daily 12 dasabuvir 0.45
(0.41, 0.50) 0.30
(0.28, 0.33) NA
ombitasvir 0.69
(0.61, 0.78) 0.69
(0.64, 0.74) NA
paritaprevir 0.34
(0.25, 0.48) 0.30
(0.23, 0.38) NA
ritonavir 0.17
(0.12, 0.24) 0.13
(0.09, 0.17) NA
Carisoprodol 250 single
dose 14 dasabuvir 0.96
(0.91, 1.01) 1.02
(0.97, 1.07) 1.00
(0.92, 1.10)
ombitasvir 0.98
(0.92, 1.04) 0.95
(0.92, 0.9 |
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