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)

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

CrCl=creatinine clearance; ABC=abacavir; 3TC=lamivudine; TDF=tenofovir disoproxil fumarate; FTC=emtricitabine; FDA=Food and Drug
Administration; CI=confidence interval; AEs=adverse events; INSTI=integrase strand transfer inhibitor; PI=protease inhibitor; NRTI=nucleoside reverse
transcriptase inhibitor; ARVs=antiretrovirals; NNRTI=nonnucleoside reverse transcriptase inhibitor; ITT–E=intention-to-treat–exposed.

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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