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HIV-1 Maturation Inhibitor BMS-955176: Pharmacokinetic and Exposure-Response Analysis
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Reported by Jules Levin
CROI 2016 Feb 22-24 Boston
H Sevinsky,1 P Ravindran,1 B Vakkalagadda,1 D Schuermann,2 C Hwang,1 D Hawthorne,1 H Xiao,1 N Ray,1 M Lataillade,3 T Eley1
1Bristol-Myers Squibb, Research and Development, Princeton, NJ, USA; 2Charite Research Organisation GmbH, Chariteplatz 1, 10117 Berlin, Germany; 3Bristol-Myers Squibb, Research and Development, Wallingford, CT, USA
Second-Generation HIV-1 Maturation Inhibitor BMS-955176: Antiviral Activity and Safety with Atazanavir ± Ritonavir - (07/22/15)
Attachment Inhibitor Prodrug BMS-663068 in Antiretroviral-Experienced Subjects: Week 48 Analysis - (02/27/15)
"The overall antiviral activity and safety results from AI468002, a three-part BMS-955176 proof-of-concept study in HIV-1-infected subjects have been presented previously.9
- In Part A of the study, 10 days of BMS-955176 monotherapy in HIV-1 subtype B-infected subjects, resulted in maximum median changes in HIV-1 RNA ranging from -0.50 to -1.70 log10 c/mL at study discharge (Day 24).9
- Maximum median declines plateaued at ~1.64 log10 c/mL at doses of 40-120 mg QD.9
- BMS-955176 also showed similar antiviral activity in subjects with either
wild-type HIV-1 or HIV-1 with Gag polymorphisms.9
- In Part B, coadministration of BMS-955176 80 mg + atazanavir 400 mg for 28 days resulted in a maximum median decline in HIV-1 RNA of 2.23 log10 c/mL, which was similar to the decline observed with the standard-of-care treatment.9
- In Part C, 10 days of BMS-955176 monotherapy in HIV-1 subtype C-infected subjects resulted in a maximum median decline of 1.35 log10 c/mL at the 40 mg dose.9
We present the exposure-response analyses from Part A to guide BMS-955176 dose selection for Phase IIb studies."
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