Comparison of INSTI – Phase 2 ARV-trial.com Comparison of INSTI – Phase 2 BIC Phase 2 Study

BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF ARV-trial.com BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF Design Randomisation 2:1 Double-blind W24 W48 > 18 years ARV-naïve HIV RNA > 1 000 c/mL CD4 ≥ 200/mm3 HBs Ag and HCV Ab negative N = 65 BIC + FTC/TAF + DTG placebo 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 ARV-trial.com 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 (log10 c/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 Median eGFR (Cockroft-Gault), mL/min 130 122 Premature discontinuation, N Adverse event Lost to follow-up Non-compliance 1 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160

BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF ARV-trial.com BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF 58 HIV RNA < 50 c/mL (ITT, snapshot) W24 (primary endpoint) 97 2 91 6 3 20 40 60 80 100 Virologic response non-response No data % W48 Difference (95% CI) = 6.4% (- 6.0 to 18.8) 97 3 94 6 20 40 60 80 100 Virologic response failure No data % Difference (95% CI) = 2.9% (- 8.5 to 14.2) DTG + FTC/TAF (N = 33) BIC + FTC/TAF (N = 65) CD4 increase at W48 (mean) BIC: + 258/mm3 vs DTG: + 192/mm3 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160

BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF ARV-trial.com BIC Phase 2 Study: BIC + FTC/TAF vs DTG + FTC/TAF 62 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 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 13 9 8 6 9 3 13 9 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 BIC Phase 2 Sax PE. Lancet HIV 2017; 4:e154-e160