The Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) and Tybost (cobicistat) labels were recently updated to include drug-drug interaction data with direct oral anticoagulants. The specific changes to each label include the following.
Genvoya and Stribild are both expected to increase the exposures of apixaban, rivaroxaban, betrixaban, dabigatran and edoxaban. The specific recommendations are as follows:
Apixaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration with Genvoya or Stribild depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.
Rivaroxaban: Coadministration of rivaroxaban with Genvoya or Stribild is not recommended because it may lead to an increased bleeding risk.
Betrixaban, dabigatran, edoxaban: Due to potentially increased bleeding risk, dosing recommendation for coadministration of betrixaban, dabigatran or edoxaban with a P-gp inhibitor such as Genvoya or Stribild depends on the direct oral anticoagulant indication and renal function. Refer to the direct oral anticoagulant dosing instructions for coadministration with P-gp inhibitors in the direct oral anticoagulant prescribing information.
Tybost coadministered with atazanavir or darunavir:
Apixaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration of apixaban with Tybost depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.
Rivaroxaban: Coadministration of rivaroxaban with Tybost is not recommended because it may lead to an increased bleeding risk.
Tybost coadministered with atazanavir:
Betrixaban, dabigatran and edoxaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration of betrixaban, dabigatran, or edoxaban with a P-gp inhibitor such as Tybost coadministered with atazanavir depends on DOAC indication and renal function. Refer to DOAC dosing instructions for coadministration with P-gp inhibitors in DOAC prescribing information.
Tybost coadministered with darunavir:
Betrixaban, dabigatran and edoxaban: No dose adjustment.
Genvoya and Stribild are both expected to increase the exposures of apixaban, rivaroxaban, betrixaban, dabigatran and edoxaban. The specific recommendations are as follows:
Apixaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration with Genvoya or Stribild depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.
Rivaroxaban: Coadministration of rivaroxaban with Genvoya or Stribild is not recommended because it may lead to an increased bleeding risk.
Betrixaban, dabigatran, edoxaban: Due to potentially increased bleeding risk, dosing recommendation for coadministration of betrixaban, dabigatran or edoxaban with a P-gp inhibitor such as Genvoya or Stribild depends on the direct oral anticoagulant indication and renal function. Refer to the direct oral anticoagulant dosing instructions for coadministration with P-gp inhibitors in the direct oral anticoagulant prescribing information.
Tybost coadministered with atazanavir or darunavir:
Apixaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration of apixaban with Tybost depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.
Rivaroxaban: Coadministration of rivaroxaban with Tybost is not recommended because it may lead to an increased bleeding risk.
Tybost coadministered with atazanavir:
Betrixaban, dabigatran and edoxaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration of betrixaban, dabigatran, or edoxaban with a P-gp inhibitor such as Tybost coadministered with atazanavir depends on DOAC indication and renal function. Refer to DOAC dosing instructions for coadministration with P-gp inhibitors in DOAC prescribing information.
Tybost coadministered with darunavir:
Betrixaban, dabigatran and edoxaban: No dose adjustment.
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Elizabeth Thompson
Division of Antiviral Products
Food and Drug Administration
Michael Stanfield Jr.
Division of Antiviral Products
Food and Drug Administration
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