Glecaprevir/Pibrentasvir and Lopinavir/Ritonavir

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

Higher exposures for GLE (Cmax increased to 2.6-fold, AUC increased to 4.4-fold, and C24 increased to 19-fold) and PIB (Cmax increased 40, AUC increased to 2.5 fold, and C24 increased to 4.2 fold) were observed when coadministered with LPV/r compared to GLE/ PIB alone. LPVand ritonavir were similar.  

Study Conclusions

The use of LPV/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