Fostemsavir + Maraviroc = Unknown or no reaction

Effect on Concentration

Fostemsavir
Increase
Applies within class?
No
Maraviroc
Increase
Applies within class?
No

Pharmacologic Effects

Fostemsavir
Effect
N/A
Applies within class?
No
Maraviroc
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 22-Nov-2022

Summary

The authors concluded that there was no clinically relevant effect of Fostemsavir 600 mg BID on maraviroc 300 mg BID. As the 90% CIs included 1, the modest effects of maraviroc on BMS-663038 are unlikely to be clinically relevant. At the administered doses, the coadministration of Fostemsavir and maraviroc requires no dose adjustments.

Sources

Fostemsavir vs maraviroc ^

Study Design

Fourteen healthy subjects were enrolled in this open label, single-sequence, two-way drug interaction study. Patients received Fostemsavir (BMS-663068) 600 mg BID as an extended release formulation between days 1 and 3, with a single dose of BMS-663068 administered on the morning of day 4. Following three days of washout period, they received maraviroc 300 mg BID between days 7 and 11. Subjects then received Fostemsavir (BMS-663068) and maraviroc 300 mg BID between days 12 and 17 with single doses of both BMS-664048 and maraviroc given on the morning of day 18. Blood samples for PK of BMS-663068 were collected on days 4 and 18; and samples for PK of maraviroc were obtained on days 11 and 18.

Study Results

Multiple dose co-administration of BMS-663068 with maraviroc resulted in a 13% increase in GMR of Fostemsavir Cmax (90% CI: 0.962-1.323), a 10% increase in AUC (90% CI: 0.993-1.226), and a 10% decrease in C12 (90% CI: 0.691-1.174), compared with BMS-663068 given alone. Co-administration of maraviroc with Fostemsavir resulted in a 0.6% increase in the steady-state Cmax of maraviroc (90% CI: 0.844-1.199), a 25% increase in AUC (90% CI: 1.076-1.44), and a 37% increase in C12 (90% CI: 1.257-1.483) compared with maraviroc monotherapy. 90% CIs for maraviroc Cmax and AUC were within pre-specified bounds. All treatments were generally well tolerated.

Study Conclusions

References

M Chang, E Myers, P Ravindran, J Wang, L Reynolds, V Fishman, et al. Drug-drug interaction study between hiv-1 attachment inhibitor bms-663068 and maraviroc in healthy subjects. 17th International Workshop On Clinical Pharmacology Of Hiv And Hepatitis Therapy. Washington, DC. ; 2016.