Date of report: 09 May 2019
Reported case interaction between
 Cobicistat and Atorvastatin

FLS Science

Drugs suspected to be involved in the DDI

Drug A
Cobicistat (Perpetrator)
Daily Dose
150 (mg)
Dose adjustment performed
No
Administration Route
Oral
Start date
Unknown
End date
Ongoing
Drug B
Atorvastatin (Victim)
Daily Dose
40 (mg)
Dose adjustment performed
No
Administration Route
Oral
Start date
Feb. 1, 2019
End date
Ongoing

Complete list of drugs taken by the patient

Antiretroviral treatment
Darunavir/Cobicistat/Emtricitabine/Tenofovir-AF
Complete list of all comedications taken by the patient, included that involved in the DDI
Atrovastatin, cotrimoxazole, fenofibrate, alprazolam

Clinical case description

Gender
Male
Age
56
eGFR (mL/min)
>60
Liver function impairment
No
Description
56 year-old male. Current smoker. HIV infection on cART with darunavir/cobicistat/FTC/TAF. Dyslipidemia on treatment with atorvastatin. Suboptimal control of LDL-cholesterol with atorvastatin 20 mg qd (LDL 170 mg/dL; target <130 mg/dL). In February 2019 atorvastatin dose in increased to 40 mg qd. Good tolerance. In May 2019 LDL-cholesterol has decreased to 117 mg/dL. Liver enzyme levels (AST/ALT) and CPK levels remain within the normal range.

Outcome

No unwanted outcome

Editorial Comment

Coadministration of darunavir/cobicistat and atorvastatin increased atorvastatin AUC and Cmax by 290% and 319% due to inhibition of CYP3A4, OATP1B1 and BCRP by darunavir/cobicistat. 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. Suboptimal cardiovascular risk management has been described in HIV patients. Intensification of lipid lowering therapy and control of other cardiovascular risk factors may be required (Rosan A van Zoest, et al. Eur J Prev Cardiol. 2017 Aug; 24(12): 1297–1307).