About: Week 48 Results of EMERALD: A Phase 3, Randomized, Non-inferiority Study Evaluating the Efficacy and Safety of Switching from Boosted-protease Inhibitors (bPI) Plus Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) Regimens to the Once Daily (QD), Single-tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Virologically Suppressed, HIV-1-infected Adults

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About: Week 48 Results of EMERALD: A Phase 3, Randomized, Non-inferiority Study Evaluating the Efficacy and Safety of Switching from Boosted-protease Inhibitors (bPI) Plus Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) Regimens to the Once Daily (QD), Single-tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Virologically Suppressed, HIV-1-infected Adults Goto Sponge NotDistinct Permalink

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type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	Week 48 Results of EMERALD: A Phase 3, Randomized, Non-inferiority Study Evaluating the Efficacy and Safety of Switching from Boosted-protease Inhibitors (bPI) Plus Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) Regimens to the Once Daily (QD), Single-tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Virologically Suppressed, HIV-1-infected Adults
Creator	Bavari, Sina Baric, Ralph Feldmann, Friederike Sims, Amy Bannister, Roy Cihlar, Tomas Cronin, Jacqueline Jordan, Robert Soloveva, Veronica Sheahan, Timothy Siegel, Dustin Babusis, Darius Feldmann, Heinrich Gomba, Laura Hogg, Alison Porter-Poulin, Danielle Ray, Adrian Spiropoulou, Christina Trantcheva, Iva Warren, Travis Weidner, Jessica Cockrell, ; De Wit, ; Denison, ; Feng, ; Lo, ; Mackman, ; Stuart Nichol, ;
Source	PMC
abstract	BACKGROUND: EMERALD is evaluating the efficacy and safety of switching from bPI + FTC/TDF regimens (control) to D/C/F/TAF 800/150/200/10 mg in virologically suppressed, HIV-1-infected adults. We present Week 48 primary results. METHOD: EMERALD (NCT02269917) is a randomized, active-controlled, open-label, international, multicenter, parallel-group, non-inferiority trial. Virologically suppressed (viral load [VL] < 50 c/mL for ≥2 months), HIV-1-infected adults were randomized (2:1) to switch to D/C/F/TAF or continue control. The FDA-stipulated primary endpoint was non-inferiority of D/C/F/TAF vs. control regarding % virologic rebound (confirmed VL ≥ 50 c/mL or premature discontinuations with last VL ≥ 50 c/mL) cumulative through Week 48 (4% margin). RESULT: 1141 patients were randomized and treated (N = 763 D/C/F/TAF; N = 378 control); median age 46; 18% women; 76% white; 58% on >2 previous ARVs (prior to screening regimen); 15% with previous non-DRV virologic failure (VF). Virologic rebound through Week 48 was non-inferior for D/C/F/TAF (2.5%; n = 19) vs. control (2.1%; n = 8) (Δ0.4%, 95% CI: –1.5%; 2.2%; P < 0.001). Most rebounders (12/19 [63%] vs. 4/8 [50%]) resuppressed by Week 48 without change in therapy. Week 48 virologic suppression rates (VL < 50 c/mL; FDA Snapshot) were 94.9% vs. 93.7% (Δ1.2%, 95% CI: −1.7%;4.1%) and VF rates (VL ≥ 50 c/mL; Snapshot) were 0.8% vs. 0.5% (Δ0.3%, 95% CI: −0.7%;1.2%), with no discontinuations for VF. No resistance-associated mutations related to any study drug were observed. Adverse events (AEs) were similar between arms: AE-related discontinuations (1.4% vs. 1.3%); grade 3–4 AEs (6.8% vs. 8.2%); serious AEs (4.6% vs. 4.8%); and no deaths. Renal and bone parameters favored D/C/F/TAF vs. control. TC and LDL-C slightly favored control vs. D/C/F/TAF, with no clinically significant difference in TC/HDL-C ratio between arms (Table 1). CONCLUSION: Percentage of virologic rebound after switching to D/C/F/TAF was non-inferior to control cumulative through Week 48, with high suppression rates (94.9%), no resistance development, better bone and renal safety parameters and similar TC/HDL-C ratio. D/C/F/TAF maintains the high genetic barrier to resistance of darunavir with the safety advantages of TAF, even in patients with a history of non-DRV VF. DISCLOSURES: C. Orkin, Janssen Pharmaceuticals: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research grant, Speaker honorarium and Travel bursary to attend conference. MSD: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research grant, Speaker honorarium and Travel bursary to attend conference. Viiv Healthcare: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research grant, Speaker honorarium and Travel bursary to attend conference. Gilead Sciences: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research grant, Speaker honorarium and Travel bursary to attend conference. J. M. Molina, Merck / Gilead: Scientific Advisor, Research grant. Janssen / Viiv / BMS / Teva: Scientific Advisor, Speaker honorarium. Gilead: Speaker’s Bureau, Speaker honorarium. J. Gallant, Janssen Therapeutics: Investigator, Research support. E. Negredo, Janssen: Board Member, Scientific Advisor and Speaker’s Bureau, Speaker honorarium. J. Gathe, Janssen: Consultant and Investigator, Research grant and Speaker honorarium. J. Eron, Janssen: Consultant and Grant Investigator, Consulting fee and Grant recipient. E. Van Landuyt, Janssen: Employee and Shareholder, Salary. E. Lathouwers, Janssen: Employee and Shareholder, Salary. V. Hufkens, Janssen: Employee and Shareholder, Salary. R. Petrovic, Janssen: Employee and Shareholder, Salary. M. Opsomer, Janssen: Employee and Shareholder, Salary.
has issue date	2017-10-04(xsd:dateTime)
bibo:doi	10.1093/ofid/ofx180.009
has license	cc-by-nc-nd
sha1sum (hex)	7c0a84e461b53a1db6645bc4577a3e0b54783abb
schema:url	https://doi.org/10.1093/ofid/ofx180.009
resource representing a document's title	Week 48 Results of EMERALD: A Phase 3, Randomized, Non-inferiority Study Evaluating the Efficacy and Safety of Switching from Boosted-protease Inhibitors (bPI) Plus Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF) Regimens to the Once Daily (QD), Single-tablet Regimen (STR) of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Virologically Suppressed, HIV-1-infected Adults
has PubMed Central identifier	PMC5631339
schema:publication	Open Forum Infect Dis
resource representing a document's body	covid:7c0a84e461b53a1db6645bc4577a3e0b54783abb#body_text
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