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Switch to BIC/FTC/TAF

Switch to BIC/FTC/TAF. GS-US-380-1878 GS-US-380-1844 GS-US-380-1961. GS-US-380-1961 Study : Switch to BIC/FTC/TAF. Design. Randomisation 1 : 1 Open-label. W48. HIV+ ≥ 18 years Women On E/C/F/TAF or TDF or ATV/r + FTC/TDF HIV RNA < 50 c/mL ≥ 6 months

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Switch to BIC/FTC/TAF

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  1. Switch to BIC/FTC/TAF • GS-US-380-1878 • GS-US-380-1844 • GS-US-380-1961

  2. GS-US-380-1961 Study: Switch to BIC/FTC/TAF • Design Randomisation 1 : 1 Open-label W48 HIV+ ≥ 18 years Women On E/C/F/TAF or TDF or ATV/r + FTC/TDF HIV RNA < 50 c/mL ≥ 6 months eGFR (Cockroft-Gault) > 50 mL/min N = 234 N = 236 • Endpoints • Primary: proportion of patients with HIV RNA ≥ 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if upper margin of a two-sided 95.001% CI for the difference = 4% • Secondary: proportion of patients with HIV RNA < 50 c/mL at W48 (ITT, snapshot) Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

  3. GS-US-380-1961 Study: Switch to BIC/FTC/TAF Baseline characteristics and patient disposition Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

  4. GS-US-380-1961 Study: Switch to BIC/FTC/TAF Virologic outcome at W48 • Emergence of resistance in BIC/FTC/TAF: 0/1 patient analysed for resistance • Emergence of resistance in Continuation ART:1/2 patients analysed for resistance (M184I/V) BIC/FTC/TAF (N = 234) Continuation ART (N = 236) % 96 95 100 80 60 40 Difference : 0.0% (95.001% CI : - 2.9 to 2.9) 20 3 3 2 2 0 HIV RNA ≥ 50 c/mL HIV RNA < 50 c/mL No virologic data Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

  5. GS-US-380-1961 Study: Switch to BIC/FTC/TAF Adverse events between D0 and W48, % • Median change in eGFRCG at W48: • - 1.8 mL/min BIC/FTC/TAF vs - 2.7 mL/min Continuation ART (p = 0.70) Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

  6. GS-US-380-1961 Study: Switch to BIC/FTC/TAF Median percent change in quantitative proteinuria at W48 BIC/FTC/TAF Continuation ART Baseline TDF-containing regimen Baseline non-TDF-containing regimen • UACRp = 0.40 • RBP:Crp < 0.001 • β-2-m:Crp < 0.001 • UACRp = 0.09 • RBP:Crp = 0.14 • β-2-m:Crp = 0.19 80 60 40 20 17 11 10 20 7 0 0 -4 -4 -7 -9 -20 -27 -40 -29 UACR: urine albumin:creatinine ratio ; RBP: retinol-binding protein ; β-2-m: beta-2 microglobulin Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

  7. GS-US-380-1961 Study: Switch to BIC/FTC/TAF Median % change in fasting lipids at W48 • Total • cholesterolns • LDL- • cholesterolns HDL- cholesterolns • Triglyceridesp < 0.001 10 4 0 -1 -1 -1 -1 -3 -4 -10 -10 -20 Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

  8. GS-US-380-1961 Study: Switch to BIC/FTC/TAF • Conclusion • Switching to BIC/FTC/TAF was non inferior to continuing ATV- and EVG-based regimens at Week 48, in women • 1.7% of participants in both groups had HIV-1 RNA ≥ 50 c/mL • 96% of women treated with BIC/FTC/TAF maintained HIV-1 RNA < 50 c/mL vs 95% with continuation of ART • No treatment-emergent resistance was observed in women receiving BIC/FTC/TAF • BIC/FTC/TAF was well tolerated, and no adverse event led to discontinuation • Changes from baseline in lipid parameters and renal markers were comparable between treatment arms Kityo C. CROI 2018, Abs. 500 GS-US-380-1961

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