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 eGFR (Cockroft-Gault) > 50 mL/min N = 234 BIC/FTC/TAF 50/200/25 mg QD BIC/FTC/TAF Continuation of baseline ART 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) GS-US-380-1961 Kityo C. CROI 2018, Abs. 500

GS-US-380-1961 Study: Switch to BIC/FTC/TAF Baseline characteristics and patient disposition BIC/FTC/TAF N = 234 Continuation ART N = 236 Median age, years 39 40 Ethnicity: white / black / hispanic, % 25 / 39 / 15 480 CD4 cell count (/mm3), median 667 704 eGFR (Cockroft-Gault), mL/min, median 99.6 102.0 ARV regimen at randomisation, % E/C/F/TAF E/C/F/TDF ATV/r + FTC/TDF 53 42 5 53 42 6 Discontinuation by W48, N (%) For adverse event, N Lost to follow-up, N Investigator discretion, N Pregnancy, N Death, N 3 (1.3%) 3 5 (2.1%) 1 2 GS-US-380-1961 Kityo C. CROI 2018, Abs. 500

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

Adverse events between D0 and W48, % GS-US-380-1961 Study: Switch to BIC/FTC/TAF Adverse events between D0 and W48, % BIC/FTC/TAF N = 234 Continuation ART N = 236 Discontinuation for adverse event Adverse event in ≥ 5% of either arm, % Nasopharyngitis Urinary tract infection Upper respiratory tract infection Headache Vulvovaginal candidiasis 8 7 6 5 2 4 Any study-drug related adverse event 20 (9%) 13 (6%) Grade 3-4 laboratory abnormalities, % Urine red blood cell count LDL-cholesterol Amylase Total cholesterol 11 3 < 1 1 Median change in eGFRCG at W48: - 1.8 mL/min BIC/FTC/TAF vs - 2.7 mL/min Continuation ART (p = 0.70) GS-US-380-1961 Kityo C. CROI 2018, Abs. 500

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

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

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 GS-US-380-1961 Kityo C. CROI 2018, Abs. 500