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The Precautionary and Prohibited Medications Database

Maintained by a collaboration of the University at Buffalo Pharmacology Specialty Laboratory and Frontier Science & Technology Research Foundation

 
Medications Glecaprevir/Pibrentasvir and Darunavir/Ritonavir
Designation Prohibited
Last updated 01-Mar-2022
Interaction History
Effect on concentration Glecaprevir/Pibrentasvir: Increase

Darunavir/Ritonavir: Increase
Pharmacologic effect Glecaprevir/Pibrentasvir: Increase

Darunavir/Ritonavir: Increase
Pharmacologic effect applies to drugs in the same class Glecaprevir/Pibrentasvir: true See drug list

Darunavir/Ritonavir: false
Pharmacologic effect description Glecaprevir/Pibrentasvir: na

Darunavir/Ritonavir: na
Potential pharmacokinetic effect Glecaprevir/Pibrentasvir: Increase

Darunavir/Ritonavir: Increase
Potential pharmacokinetic effect applies to drugs in the same class Glecaprevir/Pibrentasvir: true See drug list

Darunavir/Ritonavir: false
Potential pharmacokinetic mechanism Glecaprevir/Pibrentasvir: na

Darunavir/Ritonavir: na

Summary

The use of DRV/r with GLE/PIB is not recommended.

Sources

Drug-Drug Interactions of Glecaprevir and Pibrentasvir Coadministered With Human Immunodeficiency Virus Antiretrovirals.

Study Design
In a parallel 2-periods, open-label, single-center, phase I study, the pharmacokinetic (PK) drug interaction potential was assessed betweeen GLE/PIB and ATV/r. Healthy adults age between 18 and 55 recevied GLE 300mg/PIB 120mg (n7) once daily in period 1(Days 1-7). In period 2 (days 1-14), subjects recevied GLE/PIB with ATV 300mg/r 100mg once daily (n13). For assessment of the GLE/PIB plasma concentration, samples were collected on period 1 day 7 and period 2 days 1 and 14 prior dosing. For ATV/r, samples were collected on period 2 days 1 and 14. 
Study Results
Exposures were higher for DRV (Cmax increased 30 and AUC increased 29) and ritonavir (Cmax increased 103 and AUC increased 87) when coadministered with GLE/PIB than for DRV/r alone. GLE exposure increased (Cmax increased to 3.1 fold, AUC increased to 5.0 fold, and C24 increased to 8.2 fold) and PIB Cmax and AUC were similar (&8804;16 difference) but C24 was higher (increased 66). 
Study Conclusions
The use of DRV/r with GLE/PIB is not recommended.  
References
Koloski MP, et al.. Drug-drug interactions of glecaprevir and pibrentasvir coadministered with human immunodeficiency virus antiretrovirals. Journal Of Infectious Diseases. 2020; 2: 223-31.  

Study information updated: 01-Mar-2022