Liverpool HIV Interactions

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Potential Interaction

Darunavir/cobicistat (DRV/c)

Rosuvastatin

Quality of Evidence: Low

Summary:

Coadministration of darunavir/cobicistat (800/150 mg once daily) and rosuvastatin (10 mg) increased rosuvastatin AUC and Cmax by 93% and 277% due to inhibition of BCRP by darunavir/cobicistat. However, rosuvastatin did not affect darunavir/cobicistat exposure. When administration of rosuvastatin and darunavir/cobicistat is required it is recommended to initiate rosuvastatin with the lowest dose, and titrate to desired response while monitoring for safety. (Note, the US product label for Prezcobix states not to exceed rosuvastatin 20 mg/day.)

Description:

Coadministration with rosuvastatin (10 mg once daily) increased rosuvastatin AUC and Cmax by 93% and 277%. Concomitant use of a HMG CoA reductase inhibitor and darunavir/cobicistat may increase plasma concentrations of the lipid lowering agent, which may lead to adverse events such as myopathy. When administration of HMG CoA reductase inhibitors and darunavir/cobicistat is desired, it is recommended to start with the lowest dose and titrate up to the desired clinical effect while monitoring for safety.

Rezolsta Summary of Product Characteristics, Janssen-Cilag Ltd, July 2023.

Coadministration is expected to increase concentrations of rosuvastatin. Start with the lowest recommended dose and titrate while monitoring for safety (e.g., myopathy). Dosage recommendations with rosuvastatin are as follows: rosuvastatin dosage should not exceed 20 mg/day.

Prezcobix US Prescribing Information, Janssen Pharmaceuticals Inc, March 2023.

Coadministration of darunavir/cobicistat (800/150 mg once daily) and rosuvastatin (10 mg single dose) was studied in 16 HIV-negative subjects. Coadministration increased rosuvastatin AUC and Cmax by 93% and 277%.When darunavir/cobicistat is coadministered with rosuvastatin, it is recommended to initiate rosuvastatin treatment with the lowest dose and titrate to the desired response while monitoring for safety.

Evaluation of the drug-drug interaction potential between cobicistat-boosted protease inhibitors and statins. Custodio J, West A, SenGupta D, et al. 18th International Workshop on Clinical Pharmacology of Antiviral Therapy, June 14-17, 2017, Chicago. Abstract O_04.