SINGLE

For HIV-1. See Full Indication.

EFFICACY AND RESISTANCE

SINGLE: POWERFUL RESULTS IN
FIRST-LINE THERAPY1,2

A randomized, double-blind (to Week 96; open-label from Week 96 to Week 144), active-control, noninferiority trial in 833 HLA-B*5701–negative, treatment-naïve adult (≥18 years) patients with HIV-1 and CrCl ≥50 mL/min 

Baseline characteristics
Median age was 35 years, 84% of patients were male, 24% were of African American/African heritage, 68% were white, 32% had HIV-1 RNA >100,000 copies/mL, 53% had CD4+ T-cell counts <350 cells/mm3, 7% had hepatitis C virus coinfection,* and 4% were CDC Class C (AIDS) 

Virologic Response

Proven virologic response for patients taking a dolutegravir-based regimen (FDA snapshot analysis: proportion of patients with HIV-1 RNA <50 copies/mL)1,2 

Virologic Response in patients
with high baseline viral load

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

Virologic Response in Patients
With low Baseline Viral Load

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 results in treatment-naïve study population1,2

In SINGLE, no patients receiving TIVICAY had detectable decreases in susceptibility to dolutegravir or background NRTIs (ABC/3TC) in the resistance analysis data set (n=11 with confirmed HIV-1 RNA >400 copies/mL at failure or last visit and having resistance data)

Number of patients with treatment-emergent INSTI, NNRTI, or NRTI substitutions with decreases in susceptibility to ARVs studied based on the resistance analysis data set through 144 weeks2

*Hepatitis B virus coinfection was an exclusion criterion.

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; NNRTI=nonnucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; ARVs=antiretrovirals. 

References: 1. Walmsley S, Baumgarten A, Berenguer J, et al. Dolutegravir plus abacavir/lamivudine for the treatment of HIV-1 infection in antiretroviral therapy-naive patients: week 96 and week 144 results from the SINGLE randomized clinical trial. J Acquir Immune Defic Syndr. 2015;70(5):515-519. 2. Data on file, ViiV Healthcare.

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