Single

For HIV-1. See Full Indication.

EFFICACY AND RESISTANCE

GILEAD-SPONSORED TRIAL—STUDY 1490: SEE HOW A DOLUTEGRAVIR-BASED REGIMEN COMPARED WITH A BICTEGRAVIR-BASED REGIMEN1,2

A randomized, double-blind, multicenter, active-controlled, noninferiority trial in 645 treatment-naïve (≥18 years) patients with HIV-1. Study 1490 was designed to assess whether BIC/FTC/TAF was noninferior to DTG+FTC/TAF

Baseline characteristics
Mean age was 37 years; 88% of patients were male, 31% were of African American/African heritage, 59% were white, 12% had HIV-1 RNA >100,000 copies/mL, 12% had CD4T-cell counts <200 cells/mm3, 4% had hepatitis B and/or C virus coinfection, and 8% were CDC Class C (AIDS)   

Virologic Response

noninferior RESULT

BIC/FTC/TAF vs DTG + FTC/TAF at 96 weeks in treatment-naїve patients3

Virologic Response in Patients
With High Baseline Viral Load3

Subgroup analysis

Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load

Virologic Response in Patients
With low Baseline Viral Load3

Subgroup analysis

Virologic response (HIV-1 RNA <50 copies/mL) stratified by baseline viral load

Resistance Results

High barrier to resistance with dolutegravir is supported by 96-week results in STUDY 14903

In Study 1490, no patients in either treatment arm had treatment-emergent resistance to study drugs in the resistance analysis data set with confirmed HIV-1 RNA ≥200 copies/mL at failure or study drug discontinuation.

Number of patients with treatment-emergent INSTI substitutions based on the resistance analysis data set through 96 weeks3

FTC=emtricitabine; TAF=tenofovir alafenamide; DTG=dolutegravir; BIC=bictegravir; CI=confidence interval;

INSTI=integrase strand transfer inhibitor; NRTI=nucleoside reverse transcriptase inhibitor.

References: 1. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380–1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390(10107):2073-2082. 2. BIKTARVY [package insert]. Gilead Sciences, Inc.; Foster City, CA: February 2018. 3. Stellbrink H-J, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372.

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