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.
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.