For HIV-1. See Full Indication.
EFFICACY AND RESISTANCE
FLAMINGO: POWERFUL RESULTS IN
FIRST-LINE THERAPY1,2
A randomized, open-label, active-control, noninferiority trial in 485* treatment-naïve
adult (≥18 years) patients with HIV-1 and CrCl ≥50 mL/min
Baseline characteristics
Median age was 34 years, 85% of patients were male, 23% were of African American/African heritage, 72%
were white, 25% had HIV-1 RNA >100,000 copies/mL, 35% had CD4+ T-cell counts <350 cells/mm3, 10% had
hepatitis B and/or C virus coinfection, 3% were CDC Class C (AIDS)
Virologic Response
Proven virologic response for patients taking dolutegravir-based regimens
(FDA snapshot analysis: proportion of patients with HIV-1 RNA <50 copies/mL)1
Virologic Response in Patients
with high baseline viral load1
Subgroup analysis†
Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load
Virologic Response in Patients
With low Baseline Viral Load1
Subgroup analysis†
Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load
Resistance Results
In FLAMINGO, no patients receiving TIVICAY had detectable decreases in susceptibility to dolutegravir or background NRTIs (ABC/3TC or TDF/FTC) in the resistance analysis data set (n=2 with confirmed HIV-1 RNA >400 copies/mL at failure or last visit and having resistance data)
Number of patients with treatment-emergent INSTI, PI, or NRTI substitutions with decreased susceptibility to ARVs studied based on the resistance analysis data set through 96 weeks2
*484 patients included in the efficacy and safety analyses.1
†Prespecified secondary endpoint; ITT–E population.
3TC=lamivudine; ABC=abacavir; AE=adverse event; ARV=antiretroviral; CDC=Centers for Disease Control and Prevention; CI=confidence interval; CrCl=creatinine clearance; FDA=Food and Drug Administration; FTC=emtricitabine; INSTI=integrase strand transfer inhibitor; ITT-E=intention-to-treat–exposed; NRTI=nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; TDF=tenofovir disoproxil fumarate.
References: 1. Molina J-M, Clotet B, van Lunzen J, et al. Once-daily dolutegravir versus darunavir plus ritonavir for treatment-naive adults with HIV-1 infection (FLAMINGO): 96 week results from a randomized, open-label, phase 3b study. Lancet HIV. 2015;2(4):e127-e136. 2. Data on file, ViiV Healthcare.
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