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ANALYSIS OF HIV PATIENTS SWITCHING TO D/C/F/TAF BY PRIOR ARV TREATMENT EXPERIENCE
Joseph J. Eron1, Chloe Orkin2, Jean-Michel Molina3, Erika Van Landuyt4, Erkki Lathouwers4, Romana Petrovic4, Richard E. Nettles5, Kimberley Brown5
1University of North Carolina Chapel Hill, Chapel Hill, NC, USA,2Royal London Hospital, London, UK,3St. Louis Hospital, Paris, France,4Janssen, Beerse, Belgium,5Janssen Scientific Affairs, LLC, Titusville, NJ, USA
HIV-1–infected patients enrolled in switch studies may not be representative of switch patients in clinical practice due to strict inclusion/exclusion criteria. EMERALD allowed entry of patients with previous virologic failure (VF) or experience with multiple antiretrovirals (ARVs); we report Week 48 results by ARV treatment experience.
EMERALD was a phase 3, randomized (2:1), non-inferiority trial that evaluated the efficacy and safety of switching to the single-tablet regimen darunavir/cobicistat/emtricitabine/ tenofovir alafenamide (D/C/F/TAF; 800/150/200/10mg), or continuing use of a boosted protease inhibitor+F/tenofovir disoproxil fumarate (control), in virologically suppressed, HIV-1–infected adults. Patients had viral load (VL) <50 copies(c)/mL for ≥2 months (1 VL ≥50 and <200 c/mL allowed in 12 months before screening) and, if available, absence of historical darunavir resistance mutations. Those with previous non-darunavir VF and prior experience with multiple ARVs were allowed. The primary endpoint was proportion of patients with virologic rebound (confirmed VL ≥50 c/mL or premature discontinuation with last VL ≥50 c/mL) cumulative through Week 48. Secondary endpoints included virologic response and VF by FDA snapshot (50 c/mL threshold). Results were evaluated by prior VF and number of ARVs previously used.
In total, 1141 patients were randomized and treated; 14.8% (N=169) had prior VF, including 7.0% (N=80) of all patients with PI VF, 11.4% (N=130) with NRTI VF, and 6.5% (N=74) with NNRTI VF, and 27.3% (N=312) had used >7 ARVs. Overall rebound rates were 2.5% for D/C/F/TAF and 2.1% for control. Response rates were 94.9% and 93.7%, respectively. No resistance associated with any study drug was observed post-baseline. In patients with ≥1 prior VF, rebound rates were 2.6% for D/C/F/TAF and 0% for control (Table); response rates were 95.7% (D/C/F/TAF) and 92.5% (control), and VF rates were 1.7% and 0%, respectively. Overall, patients in the D/C/F/TAF and control arms had low and similar rates of discontinuation due to an adverse event (AE; 1.4% vs 1.3%), grade 3-4 AEs (6.8% vs 8.2%), and serious AEs (4.6% vs 4.8%). Virologic response rates were high and safety results were consistent across subgroups by ARV treatment experience.
Virologically suppressed, HIV-1–infected adults, including those with prior VF and experience with numerous ARVs, who switched to D/C/F/TAF had low cumulative virologic rebound and high virologic response rates over 48 weeks.