Phase 2 of new ARVs

BMS-955176 (maturation inhibitor)
AI468002 Study : BMS-955176 Phase II
Original article : Hwang C. CROI 2015, Abs. 114LB
Last update : 15/05/2015

Dr Anton Pozniak
Chelsea and Westminster Hospital
London, UK

  • Virologic response rates (mITT and observed) and immunologic responses were similar across the BMS-663068 and ATV/r arms through Week 48
  • All BMS-663068 doses were generally well tolerated with no dose-response safety signals reported
  • Continuation dose of BMS-663068 1200 mg QD for the Phase IIb study
  • Phase III study in heavily treatment-experienced patients with limited therapeutic options
    • Phase III dose : 600 mg BID
    • Subjects enrolled regardless of baseline susceptibility to BMS-626529
    • A retrospective analysis will be conducted to determine whether a baseline phenotypic assay is necessary in the future

Design :

  • Phase IIa , randomised, double- blind , dose- escalating study
  • ARV-naïve (≤ 1 week of treatment) or experienced (PI and maturation inhibitor naïve ) patients, ≥ 18 years, HIV RNA > 5,000 c/mL, CD4 cell count > 200/mm3
  • For all dose groups : 8 patients on BMS-176 qd and 2 on placebo
  • HIV RNA evaluated at Day 1 to 14, Day 17-19 and Day 24

Baseline characteristics


ARV-naïve : 92% ; ARV- experienced : 8%

Maximum median reduction in HIV RNA from baseline, log10 c/mL

  • Median change in HIV RNA from baseline to day 11 was – 1.4 log10 c/ mL
  • BMS-955176 exposure-response relationship is consistent with dose-response antiviral activity

Maximum median reduction in HIV RNA, log10 c/mL by baseline Gag polymorphisms

Adverse events


* Transient grade 3 neutropenia reported as related to study drug

   

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