Liverpool HIV Interactions

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Do Not Coadminister

Darunavir/Cobicistat/ Emtricitabine/Tenofovir alafenamide (DRV/c/FTC/TAF)

Budesonide

Quality of Evidence: Very Low

Summary:

Coadministration has not been studied and is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects. Systemic corticosteroid effects including Cushing's syndrome and adrenal suppression have been reported in patients receiving strong inhibitors of CYP3A4 (such as darunavir/cobicistat) and fluticasone; this could also occur with other corticosteroids metabolised by CYP3A e.g. budesonide. A dose reduction of the glucocorticoid should be considered with close monitoring of local and systemic effects or a switch to a glucocorticoid, which is not a substrate for CYP3A4 (e.g. beclomethasone). Moreover, in case of withdrawal of glucocorticoids progressive dose reduction may have to be performed over a longer period.

Description:

Based on theoretical considerations darunavir/cobicistat is expected to increase budesonide plasma concentrations (CYP3A inhibition). Concomitant use of Symtuza and corticosteroids (all routes of administration) that are metabolised by CYP3A may increase the risk for development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression. Co-administration with CYP3A-metabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects. Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone should be considered, particularly for long-term use.

Symtuza Summary of Product Characteristics, Janssen-Cilag Ltd, June 2023.

Co-administration is expected to increase budesonide concentrations, but decrease darunavir and cobicistat concentrations. Co-administration with systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to Symtuza. Consider alternative corticosteroids. Co-administration with corticosteroids (all routed of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. Alternative corticosteroids including beclomethasone, prednisone, and prednisolone (for which PK and/ or PD are less affected by strong CYP3A inhibitors relative to other steroids) should be considered, particularly for long term use.

Symtuza US Prescribing Information, Janssen Products, March 2023.

View all available interactions with Darunavir/Cobicistat/ Emtricitabine/Tenofovir alafenamide (DRV/c/FTC/TAF) by clicking here.