Liverpool HIV Interactions

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Potential Interaction

Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir-DF (EVG/c/FTC/TDF)

Apixaban

Quality of Evidence: Very Low

Summary:

Coadministration has not been studied. Concentrations of apixaban are expected to increase due to potent CYP3A4 and P-gp inhibition by elvitegravir/cobicistat, thereby increasing the bleeding risk. The product labels for apixaban do not recommend the concomitant use with strong dual CYP3A4 and P-gp inhibitors, although the US label gives the option to use apixaban at a reduced dose if needed. Note, patients already receiving apixaban at a dose of 2.5 mg twice daily should avoid coadministration with strong dual CYP3A4 and P-gp inhibitors. Of interest, there are case reports of no adverse outcomes in HIV infected patients treated with a reduced dose of apixaban (2.5 mg twice daily) while on ritonavir or cobicistat boosted regimens which supports the option of dose reduction given in the US label. Based on metabolism and clearance a clinically significant interaction with emtricitabine and tenofovir-DF is unlikely.

Description:

Co-administration of apixaban is not recommended with Stribild. Interaction not studied with any of the components of Stribild. Co-administration with Stribild may result in increased plasma concentrations of apixaban, which may lead to an increased bleeding risk.

Stribild Summary of Product Characteristics, Gilead Sciences International Ltd, November 2021.

Coadministration may increase apixaban concentrations. Due to potentially increased bleeding risk, dosing recommendations for coadministration with Stribild depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.

Stribild Prescribing Information, Gilead Sciences Inc, September 2021.

A case was reported of a 73-year-old man with a history of AF, resolved left ventricular thrombus, and who was receiving darunavir/ritonavir (800/100 mg twice daily) for the treatment of HIV. Apixaban was initiated at 2.5 mg as recommended by the US Prescribing Information in the presence of ritonavir. The patient did not suffer thrombus or bleeding and was discharged 4 days later. Apixaban was continued indefinitely. The authors conclude this case adds to a growing body of evidence that apixaban may be safely coadministered at a reduced dose with ritonavir.

Use of apixaban in atrial fibrillation with ritonavir-boosted antiretroviral therapy: a case report. Lomakina V , Sozio SJ, and Tekle J. J Pharm Pract, 2023, 36(3):728-732.

No adverse outcomes were reported in six HIV infected patients treated with a reduced dose of apixaban (2.5 mg twice daily) while on ritonavir or cobicistat boosted regimens (DRV/r [n=3], ATV/r, LPV/r, EVG/c). The US product label for apixaban recommends to avoid concomitant use or to reduce apixaban dose by half (i.e. 2.5 mg twice daily) in presence of strong dual inhibitors of CYP3A4 and P-gp; the European label does not recommend coadministration. This case series of real-world experiences supports the option of dose reduction.

Ritonavir- or cobicistat-boosted antiretroviral therapy and direct oral anticoagulants: a case for apixaban. Nisly SA, Stevens BN. Int J STD AIDS, 2019, Int J STD AIDS. 2019, 30(7):718-722.