GSUS3801961 Switch to BICFTCTAF Design Endpoints Primary proportion of patients with HIV RNA 50 cmL at W48 ITT snapshot noninferiority if upper margin of a twosided 95001 CI ID: 1032159
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1. GS-US-380-1878GS-US-380-1844GS-US-380-1961 Switch to BIC/FTC/TAF
2. DesignEndpointsPrimary: 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)BIC/FTC/TAF 50/200/25 mg QDContinuation of baseline ARTGS-US-380-1961Randomisation1 : 1Open-labelHIV+ ≥ 18 yearsWomenOn E/C/F/TAF or TDF or ATV/r + FTC/TDF HIV RNA < 50 c/mL ≥ 6 monthseGFR (Cockroft-Gault) > 50 mL/minN = 236N = 234W48GS-US-380-1961 Study: Switch to BIC/FTC/TAFBIC/FTC/TAFKityo C. CROI 2018, Abs. 500
3. BIC/FTC/TAFN = 234Continuation ARTN = 236Median age, years3940Ethnicity: white / black / hispanic, %25 / 39 / 15480CD4 cell count (/mm3), median667704eGFR (Cockroft-Gault), mL/min, median99.6102.0ARV regimen at randomisation, %E/C/F/TAFE/C/F/TDFATV/r + FTC/TDF5342553426Discontinuation by W48, N (%)For adverse event, NLost to follow-up, NInvestigator discretion, NPregnancy, NDeath, N3 (1.3%)000305 (2.1%)01211Kityo C. CROI 2018, Abs. 500Baseline characteristics and patient dispositionGS-US-380-1961 Study: Switch to BIC/FTC/TAFGS-US-380-1961
4. Emergence of resistance in BIC/FTC/TAF: 0/1 patient analysed for resistanceEmergence of resistance in Continuation ART:1/2 patients analysed for resistance (M184I/V)Kityo C. CROI 2018, Abs. 500BIC/FTC/TAF (N = 234)Continuation ART (N = 236)Difference : 0.0% (95.001% CI : - 2.9 to 2.9)22963 953HIV RNA < 50 c/mLNo virologic data020406080100%HIV RNA ≥ 50 c/mLVirologic outcome at W48GS-US-380-1961 Study: Switch to BIC/FTC/TAFGS-US-380-1961
5. BIC/FTC/TAFN = 234Continuation ARTN = 236Discontinuation for adverse event00Adverse event in ≥ 5% of either arm, %NasopharyngitisUrinary tract infectionUpper respiratory tract infectionHeadacheVulvovaginal candidiasis8766562664Any study-drug related adverse event20 (9%)13 (6%)Grade 3-4 laboratory abnormalities, %Urine red blood cell countLDL-cholesterolAmylaseTotal cholesterol1133< 111613Median 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. 500Adverse events between D0 and W48, %GS-US-380-1961 Study: Switch to BIC/FTC/TAFGS-US-380-1961
6. Baseline non-TDF-containing regimenBaseline TDF-containing regimenKityo C. CROI 2018, Abs. 500Median percent change in quantitative proteinuria at W48BIC/FTC/TAF Continuation ART806040200-20-40-4-9-2720-2910117-417-70UACRp = 0.40RBP:Crp < 0.001β-2-m:Crp < 0.001RBP:Crp = 0.14UACRp = 0.09β-2-m:Crp = 0.19GS-US-380-1961 Study: Switch to BIC/FTC/TAFGS-US-380-1961UACR: urine albumin:creatinine ratio ; RBP: retinol-binding protein ; β-2-m: beta-2 microglobulin
7. Kityo C. CROI 2018, Abs. 500Median % change in fasting lipids at W48100-10-204-1-1-1-3-1-4-10Total cholesterolnsLDL-cholesterolnsHDL-cholesterolnsTriglyceridesp < 0.001GS-US-380-1961 Study: Switch to BIC/FTC/TAFGS-US-380-1961
8. GS-US-380-1961 Study: Switch to BIC/FTC/TAFConclusionSwitching to BIC/FTC/TAF was non inferior to continuing ATV- and EVG-based regimens at Week 48, in women1.7% of participants in both groups had HIV-1 RNA ≥ 50 c/mL96% of women treated with BIC/FTC/TAF maintained HIV-1 RNA < 50 c/mL vs 95% with continuation of ARTNo treatment-emergent resistance was observed in women receiving BIC/FTC/TAFBIC/FTC/TAF was well tolerated, and no adverse event led to discontinuationChanges from baseline in lipid parameters and renal markers were comparable between treatment armsKityo C. CROI 2018, Abs. 500GS-US-380-1961