Darunavir/Cobicistat + Fostemsavir = Unknown or no reaction

Effect on Concentration

Darunavir/Cobicistat
No change
Applies within class?
No
Fostemsavir
Increase
Applies within class?
No

Pharmacologic Effects

Darunavir/Cobicistat
Effect
N/A
Applies within class?
No
Fostemsavir
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 18-Jul-2018

Summary

Sources

Darunavir/Cobicistat versus Fostemsavir ^

Study Design

An open-label, single-sequence, pharmacokinetic (PK) study to evaluate potential drug-drug interactions when fostemsavir (formerly known as BMS-663068), a pro-drug of BMS-626529, is co-administered with darunavir/cobicistat (DRV/COBI) was conducted in16 healthy subjects. Fostemsavir 600 mg was administered BID on days 1-4, followed by fostemsavir 600mg BID with DRV (800 mg)/COBI (150 mg) once daily on days 5-14.

Study Results

Co-administration of fostemsavir with DRV/COBI increased active metabolite BMS-626529 Cmax, AUCtau, and C12, geometric means ratios (GMRs; 90% CI) by 79%, 97%, and 124% respectively. These changes in PK parameters were not considered clinically meaningful. PK parameters for DRV/COBI were not reported.

Study Conclusions

The authors state that no dose modification is required when co-administering fostemsavir with DRV/COBI based on the exposure-safety profile of fostemsavir to date.

References

B Vakkalaggadda, A Griffies, M Hesney, et al. Hiv-1 attachment inhibitor prodrug bms-663068: interactions with cobicistat and darunavir/cobicistat. Joint 55th Interscience Conference On Antimicrobial Agents And Chemotherapy Meeting. San Diego, CA. ; 2016.