Liverpool HIV Interactions

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Potential Interaction

Darunavir/cobicistat (DRV/c)

Atorvastatin

Quality of Evidence: Moderate

Summary:

Coadministration of darunavir/cobicistat (800/150 mg once daily) and atorvastatin (10 mg) increased atorvastatin AUC and Cmax by 290% and 319% due to inhibition of CYP3A4, OATP1B1 and BCRP by darunavir/cobicistat. However, atorvastatin did not affect darunavir/cobicistat exposure. When administration of atorvastatin and darunavir/cobicistat is required, it is recommended to initiate atorvastatin with the lowest dose, and titrate to desired response while monitoring for safety. A daily dose of 40 mg atorvastatin should not be exceeded with careful safety monitoring. (Note, the US product label for Prezcobix states not to exceed atorvastatin 20 mg/day.)

Description:

Coadministration with atorvastatin (10 mg once daily) increased atorvastatin AUC and Cmax by 290% and 319%. 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 atorvastatin. Start with the lowest recommended dose and titrate while monitoring for safety (e.g., myopathy). Dosage recommendations with atorvastatin are as follows: atorvastatin 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 atorvastatin (10 mg single dose) was studied in 16 HIV-negative subjects. Coadministration increased atorvastatin AUC and Cmax by 290% and 319%.When darunavir/cobicistat is coadministered with atorvastatin, it is recommended to initiate atorvastatin 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.