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An open-label, single-sequence, pharmacokinetic (PK) study was conducted to evaluate potential drug-drug interactions when fostemsavir (formerly known as BMS-663068), a pro-drug of BMS-626529, is co-administered with cobicistat (COBI) in 16 healthy subjects.Fostemsavir 600 mg was administered BID on days 1-4, followed by fostemsavir (600 mg) BID with COBI (150 mg) daily on days 5-14.
Co-administration of fostemsavir with COBI increased active metabolite BMS-626529 Cmax, AUCtau, and C12geometric mean ratios (GMRs; 90% CI) by 71%, 93%, and 136%, respectively. These changes in PK parameters were not considered clinically meaningful.PK parameters for COBI were not reported.
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.