Switch to BIC/FTC/TAF
The GS-US-380-1844 study evaluated the virologic outcome at Week 48 for patients switching to BIC/FTC/TAF treatment. Results showed no emergence of resistance in either group, with HIV RNA levels maintained below 50 c/mL. Adverse events and laboratory abnormalities were also assessed.
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-380-1844 Study: Switch to BIC/FTC/TAF Design Randomisation 1 : 1 Double-blind W48 N = 282 BIC/FTC/TAF 50/200/25 mg QD + DTG/ABC/3TC placebo HIV+ 18 years On DTG, ABC and 3TC HIV RNA < 50 c/mL 3 months eGFR (Cockroft-Gault) > 50 mL/min No active HBV infection BIC/FTC/TAF DTG/ABC/3TC 50/600/300 mg QD + BIC/FTC/TAF placebo Open-label extension N = 281 Endpoints Primary: proportion of patients with HIV RNA 50 c/mL at W48 (ITT, snapshot) ; non-inferiority if upper margin of a two-sided 95.002% CI for the difference = 4% Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
GS-US-380-1844 Study: Switch to BIC/FTC/TAF Baseline characteristics BIC/FTC/TAF N = 282 DTG/ABC/3TC N = 281 Median age, years 47 45 Female, % 12 10 Ethnicity: white / black / hispanic, % 73 / 21 / 16 73 / 22 / 19 CD4 cell count (/mm3), median 732 661 eGFR (Cockroft-Gault), mL/min, median 101 101 Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
GS-US-380-1844 Study: Switch to BIC/FTC/TAF Virologic outcome at W48 BIC/FTC/TAF (N = 282) DTG/ABC/3TC (N = 281) % 95.0 100 93.6 80 60 40 Difference : 0.7% (95.002% CI : - 1.0 to 2.8) 20 5.3 4.6 1.1 0.4 0 HIV RNA < 50 c/mL No virologic data HIV RNA 50 c/mL No emergence of resistance in either group Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
GS-US-380-1844 Study: Switch to BIC/FTC/TAF Adverse events between D0 and W48, % BIC/FTC/TAF N = 282 DTG/ABC/3TC N = 281 Discontinuation for adverse event 6 (2.1%) * 2 (0.7%) ** Adverse event in 5% of either arm, % Upper respiratory tract infection Nasopharyngitis Headache Diarrhea Arthralgia Insomnia 10 7 7 9 7 3 10 8 7 5 4 5 Any study-drug related adverse event 23 (8.2%) 44 (15.7%) p = 0.01 Study drug-related adverse event in 1%, % Headache Abnormal dreams Flatulence Nausea Diarrhea Fatigue Insomnia * Headache (N = 2), vomiting (N = 1), cerebrovascular accident (N = 1), abnormal dreams (N = 1), suicidal ideation (N = 1) ; ** headache (N = 1), pruritus (N = 1) 3 3 2 2 2 1 1 1 < 1 0 0 < 1 < 1 0 Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
GS-US-380-1844 Study: Switch to BIC/FTC/TAF Grade 3 or 4 laboratory abnormalities, N (%) BIC/FTC/TAF N = 282 DTG/ABC/3TC N = 281 Any 47 (17) 32 (11) Abnormality in 2% of either arm LDL-cholesterol Amylase ALT CK Fasting hyperglycemia 14 (5) 7 (2) * 6 (2) ** 6 (2) *** 6 (2) 13 (5) 0 0 6 (2) *** 2 (< 1) * All elevations transient and not associated with pancreatitis : lipase normal in 4/7 ** Acute HCV infection (N = 3), acute HAV infection (N = 1), alcohol (N = 1), NASH (N = 1) *** No case of rhabdomyolysis Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
GS-US-380-1844 Study: Switch to BIC/FTC/TAF BIC/FTC/TAF DTG/ABC/3TC Median change in fasting lipids (mg/dL) at week 48 Median percent change in quantitative proteinuria at W48 40 % 10 5 3 29 2 2 30 1 0 0 0 0 21 20 0 20 17 14 -1 -5 9 Total 10 -5 cholesterol: HDL-chol. p = 0.56 Total LDL HDL -10 Triglycerides p = 0.028 cholesterol p = 0.77 cholesterol p = 0.42 cholesterol p = 0.13 0 UACR RBP:Cr -2-m:Cr Mean % change in bone mineral density UACR: urine albumin:creatinine ratio RBP: retinol-binding protein -2-m: beta-2 microglobulin Spine Hip 2 2 p = 0.33 p = 0.47 1 1 0.69 0.42 Median change in eGFRCGat W48: - 4.3 mL/min BIC/FTC/TAF vs + 0.2 mL/min DTG/ABC/3TC (p < 0.001) 0.30 0.16 0 0 0 24 244 253 48 233 244 0 24 246 253 48 229 242 n n 256 262 256 265 Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
GS-US-380-1844 Study: Switch to BIC/FTC/TAF Conclusion Switching to BIC/FTC/TAF was non-inferior to remaining on DTG/ABC/3TC, at W48 No treatment emergent resistance Discontinuation for adverse event was rare: 2% on BIC/FTC/TAF and 1% on DTG/ABC/3TC at W48 Study drug-related adverse events occurred with significantly higher frequency in DTG/ABC/3TC arm Increased grade 3-4 amylase was seen in 2% of BIC/FTC/TAF and no patient on DTG/ABC/3TC The lipid, bone and renal parameters of switching to BIC/FTC/TAF were comparable to remaining on DTG/ABC/3TC through 48 weeks Molina JM. Lancet 2018;5:e357-65 GS-US-380-1844
