Labeling for Several HIV Meds Updated to Include Interaction Data With DOACs

Both Genvoya and Stribild are expected to increase exposures of some direct oral anticoagulants
Both Genvoya and Stribild are expected to increase exposures of some direct oral anticoagulants

The Food and Drug Administration (FDA) has approved labeling updates for Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; Gilead), Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate; Gilead) and Tybost (cobicistat; Gilead) to include new drug-drug interaction data. 

Genvoya and Stribild are combination antiretrovirals indicated as a complete regimen for the treatment of HIV-1 infection in specific patients. Tybost, a pharmacokinetic enhancer, is intended to increase systemic exposure of atazanavir or darunavir (once-daily) in combination with other antiretroviral agents. 

Both Genvoya and Stribild are expected to increase exposures of the following direct oral anticoagulants: apixaban, rivaroxaban, betrixaban, dabigatran, and edoxaban. For concomitant apixaban, the dosing instructions in the apixaban label regarding coadministration with CYP3A and P-gp inhibitors should be followed. Concomitant rivaroxaban with Genvoya or Stribild is not recommended due to a potentially increased risk for bleeding. For concomitant betrixaban, dabigatran, and edoxaban, dosing recommendations with Genvoya or Stribild depend on the specific anticoagulant indication and renal function; clinicians should refer to the prescribing information for these direct oral anticoagulants for dosing instructions with P-gp inhibitors.

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If Tybost is given with atazanavir or darunavir, coadministration with rivaroxaban is not recommended due to a potentially increased bleeding risk. When given with apixaban, the dosing recommendation depends on the apixaban dose; clinicians should refer to the prescribing information for apixaban regarding concomitant strong CYP3A and P-gp inhibitors.

If Tybost is given with atazanavir, the dosing recommendations for concomitant betrixaban, dabigatran, or edoxaban depend on the direct oral anticoagulant indication and renal function; clinicians should refer to the direct oral anticoagulant prescribing information for dosing instructions with P-gp inhibitors. No dose adjustment is needed for betrixaban, dabigatran, or edoxaban when given with Tybost + darunavir. 

For more information call (888) 463-6332 or visit FDA.gov.