Switch to BIC/FTC/TAF Study: Virologic Outcome at Week 48
Study GS-US-380-1878 investigated the virologic outcomes of switching to BIC/FTC/TAF at Week 48 in HIV-positive patients. The primary endpoint was the proportion of patients with HIV RNA
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author. If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Switch to BIC/FTC/TAF GS-US-380-1878 GS-US-380-1844 GS-US-380-1961
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Design Randomisation 1 : 1 Open-label W48 N = 290 HIV+ 18 years On boosted ATV or DRV + 2 NRTI (ABC/3TC or FTC/TDF) HIV RNA < 50 c/mL 6 months eGFR (Cockroft-Gault) > 50 mL/min BIC/FTC/TAF 50/200/25 mg QD Continuation of baseline ART N = 287 Endpoint Primary: proportion of patients with HIV RNA 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if upper margin of a two-sided 95.002% CI for the difference = 4% GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Baseline characteristics and patient disposition BIC/FTC/TAF N = 290 Continuation ART N = 287 Median age, years 48 47 Female, % 16 18 Ethnicity: white / black / hispanic, % 52 / 27 / 21 59 / 25 / 16 CD4 cell count (/mm3), median 617 626 HBV / HCV co-infection, % 8 / 5 6 / 5 eGFR (Cockroft-Gault), mL/min, median 107 105 Discontinuation by W48, N (%) For adverse event, N For lack of efficacy, N Investigator discretion, N Consent withdrawal, N Loss to follow-up, N Non-compliance, N Protocol violation, N Death, N 16 (5.5%) 2 1 1 9 0 1 1 1 26 (9.1%) 1 0 1 14 3 1 5 1 GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Virologic outcome at W48 BIC/FTC/TAF (N = 290) Continuation ART (N = 287) % 100 92.1 88.9 80 60 40 Difference : 0% (95.002% CI: - 2.5 to 2.5) 20 9.4 6.2 1.7 1.7 0 HIV RNA < 50 c/mL Difference : 3.3% (95.002% CI : - 1.6 to 8.2) No virologic data HIV RNA 50 c/mL Patients analysed for resistance: 1 BIC/FTC/TAF vs 3 Continuation ART Emergence of resistance : 0/1 vs 1/3 (L74V in a patient on ABC/3TC + DRV/r) GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Adverse events between D0 and W48, % BIC/FTC/TAF N = 290 Continuation ART N = 287 2 1 Discontinuation for adverse event, N Rash ; Schizophrenia Fracture/acute kidney injury Adverse event in 5% of either arm, % Headache Diarrhea Nasopharyngitis Upper respiratory tract infection Back pain Arthralgia 12 8 7 7 5 4 4 6 12 8 6 5 Grade 3-4 laboratory abnormalities, % LDL-cholesterol Amylase Glycosuria ALT Total bilirubin Total cholesterol Hematuria 3.9 2.1 2.1 2.1 0.7 0.7 1.7 4.0 2.1 1.1 1.4 15.4 2.2 2.7 GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Median percent change in quantitative proteinuria at W48 Baseline FTC/TDF-containing regimen Baseline ABC/3TC-containing regimen BIC/FTC/TAF Continuation ART % UACR RBP:Cr -2-m:Cr UACR RBP:Cr -2-m:Cr % 40 40 34.9 31.6 25.8 30 20 30 20 9.9 7.3 5.4 10 0 4.2 10 0 1.1 -2.1 -10 -10 -20 -30 -40 -20 -30 -40 -17.7 -19.5 -40.3 -50 -50 UACR: urine albumin:creatinine ratio ; RBP: retinol-binding protein ; -2-m: beta-2 microglobulin Median change in eGFRCGat W48: - 4.3 mL/min BIC/FTC/TAF vs + 0.2 mL/min continuation ART (p < 0.001) GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Median Fasting Lipid Changes at Week 48 (mg/dL) BIC/FTC/TAF Continuation ART Total LDL HDL Triglycerides Total Cholesterol: HDL p = 0.033 1,5 Cholesterol Cholesterol Cholesterol 30 1,0 p = 0.32 p = 0.47 p = 0.13 p = 0.002 20 0,5 10 0 1 5 3 3 1 4 0,0 0 0 -0,2 -0,5 -10 -6 -1,0 -20 -30 -1,5 Taking lipid lowering agents at baseline: B/F/TAF : 16.2%, Continuation ART : 15.7%, p = 0.91 Initiated lipid lowering agents during the study: B/F/TAF : 2.8%, Continuation ART: 3.5%, p = 0.64 GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
GS-US-380-1878 Study: Switch to BIC/FTC/TAF Conclusions Switching to BIC/FTC/TAF was non-inferior to remaining on a boosted protease inhibitor + 2 NRTI 1.7% of subjects in each arm had HIV-1 RNA 50 c/mL through 48 weeks 92.1% of subjects treated with BIC/FTC/TAF maintained virologic suppression vs 88.9% in the continuation arm No treatment emergent resistance in patients who switched to BIC/FTC/TAF 1 subject who continued DRV/r + ABC/3TC developed resistance mutation to ABC BIC/FTC/TAF was well tolerated Adverse events were comparable between arms at week 48 mild headache was reported more with BIC/FTC/TAF but was mostly transient and low grade Less than 1% of patients discontinued due to an adverse event in both arms No difference in grade 3 or 4 laboratory abnormalities between arms, except for more total bilirubin abnormalities in continuation arm due to ATV use Statistically significant improvements in triglycerides and total cholesterol:HDL ratio in subjects who switched to BIC/FTC/TAF GS-US-380-1878 Daar ES. Lancet 2018;5:e347-56
