Comparison of INSTI vs. BIC Phase 2 Study
"Explore the findings from the comparison of INSTI Phase 2 and BIC Phase 2 studies, evaluating virologic response, adverse events, and patient characteristics in HIV treatment. Gain insights into the efficacy and safety of BIC + FTC/TAF vs. DTG + FTC/TAF regimens."
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Presentation Transcript
Comparison of INSTI Phase 2 BIC Phase 2 Study
BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF Design Randomisation 2:1 Double-blind W24 W48 > 18 years ARV-na ve N = 65 BIC + FTC/TAF + DTG placebo HIV RNA > 1 000 c/mL CD4 200/mm3 HBs Ag and HCV Ab negative DTG + FTC/TAF + BIC placebo N = 33 BIC: 75 mg QD DTG: 50 mg QD Objective % HIV RNA < 50 c/mL at W24 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160
BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF Baseline characteristics and patient disposition BIC + FTC/TAF N = 65 DTG + FTC/TAF N = 33 Median age, years 30 36 Female, % 2 9 Race : white, % 58 55 HIV RNA (log10c/mL), median 4.41 4.48 HIV RNA > 100 000 c/mL, % 15 21 CD4 cell count (/mm3), median 441 455 CD4 < 200 per mm3, % 5 9 Median eGFR (Cockroft-Gault), mL/min 130 122 Premature discontinuation, N Adverse event Lost to follow-up Non-compliance 2 1 1 0 2 0 1 1 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160
58 BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF HIV RNA < 50 c/mL (ITT, snapshot) W24 (primary endpoint) W48 % % 97 97 100 100 94 91 BIC + FTC/TAF (N = 65) 80 80 DTG + FTC/TAF (N = 33) 60 60 40 40 20 20 6 6 3 3 2 2 0 0 0 0 Virologic response Difference (95% CI) = 2.9% (- 8.5 to 14.2) Virologic failure No data Virologic response Virologic non-response No data Difference (95% CI) = 6.4% (- 6.0 to 18.8) CD4 increase at W48 (mean) BIC: + 258/mm3 vs DTG: + 192/mm3 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160
62 BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF Adverse events, % BIC + FTC/TAF N = 65 DTG + FTC/TAF N = 33 Adverse event 5% in either group Diarrhea Nausea Headache Upper respiratory tract infection Fatigue Arthralgia Chlamydial infection Back pain Furuncle Flatulence Gastroenteritis Costochondritis Hemorrhoids Pruritis 12 8 8 8 6 6 6 6 5 2 2 0 0 0 12 12 3 0 6 6 3 0 6 6 6 6 6 6 Grade 2-4 laboratory abnormalities 8% in either group Creatine kinase AST Hyperglycemia LDL-cholesterol 1 patient in the BIC + FTC/TAF group with a past history of urticaria and atopic dermatitis discontinued study drug after W24 due to urticaria 13 9 8 6 9 3 13 9 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160
