Presentation Abstract

Session: 184-Antiretrovirals: Efficacy, Safety and Indications
Thursday, Sep 12, 2013, 3:00 PM - 5:30 PM
Presentation Title: H-1464a - Once-Daily Dolutegravir (DTG) is Superior to Darunavir/Ritonavir (DRV/r) in Antiretroviral‑Naive Adults: 48 Week Results from FLAMINGO (ING114915)
Location: Meeting Room 505
Presentation Number: H-1464a
Pres. Time: Thursday, Sep 12, 2013, 4:30 PM - 4:45 PM
Category: H2
Keywords: dolutegravir; integrase
Author(s): J. Feinberg1, B. Clotet2, M-A. Khuong3, A. Antinori4, J. van Lunzen5, I. M. Dumitru6, V. Pokrovskiy7, J. Fehr8, R. Ortiz9, M. Saag10, J. Harris11, C. Brennan12, S. Min12;
1Univ. of Cincinnati, Cincinnati, OH, 2Hosp. Germans Trias, Badalona, SPAIN, 3Hôpital Delafontaine, Saint-Denis, FRANCE, 4Istituto Nazionale Malattie Infettive, Roma, ITALY, 5Univ.sklinikum Hamburg-Eppendorf, Hamburg, GERMANY, 6Clinical Infectious Diseases Hosp., Constanta, ROMANIA, 7Central Res. Inst. for Epidemiology, Moscow, RUSSIAN FEDERATION, 8Univ. Zürich, Zurich, SWITZERLAND, 9Orlando Immunology Ctr., Orlando, FL, 10Univ. of Alabama at Birmingham, Birmingham, AL, 11GlaxoSmithKline, Stockley Park, UNITED KINGDOM, 12GlaxoSmithKline, Research Triangle Park, NC.
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Abstract: Background: In naives, the integrase inhibitor (INI) DTG was superior to EFV in SINGLE and non-inferior to RAL in SPRING-2 with no treatment-emergent (TE) INI resistance. FLAMINGO compares DTG to DRV/r. Methods: Multicenter, randomized, open label, non-inferiority (-12% margin, with pre-specified test for superiority) study of HIV-1 infected ART-naive adults with HIV-1 RNA ≥1000 c/mL and no primary RT/PR mutations; patients (pts) randomized 1:1 to DTG 50mg QD or DRV/r 800/100mg QD with investigator-selected TDF/FTC or ABC/3TC, stratified by HIV RNA (≤/>100k c/mL) and NRTI. Primary endpoint: % with HIV-1 RNA <50 c/mL (FDA snapshot) through Wk 48. Results: 484 pts were randomized and treated (242 in each arm). Baseline (BL) median age 34 yrs, 15% female, 28% non-white, 25% RNA >100k c/mL, 33% ABC/3TC. At Wk 48, 90% of DTG and 83% of DRV/r pts had HIV-1 RNA <50 c/mL; adjusted difference 7.1 % (95% CI: 0.9, 13.2), demonstrating statistical superiority (p=0.025). Median CD4 increases were similar (210 c/mm3 each). Pts on DTG had significantly fewer ≥Grade 2 LDL values 2% vs. 7%, p<0.001. Confirmed virologic failure (>200 c/mL HIV-1 RNA) occurred in 2 (<1%) pts in each arm, with no primary TE IN/PR/RT mutations. Most commonly (≥10%) reported adverse events (AEs) were diarrhea (DTG 17%, DRV/r 29%), nausea (16%, 18%), and headache (15%, 10%). Discontinuation due to AEs was lower for DTG (1% vs. 4%). Conclusions: At Wk 48, once-daily DTG was superior to DRV/r in treatment-naive HIV-1 infected pts. No TE IN, PI or NRTI mutations were seen in either arm. DTG is an important new option for first-line HIV treatment.

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