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) 

Primary endpoint
Proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 using FDA snapshot analysis with 10% noninferiority margin with prespecified tests for superiority 

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 

Statistically superior difference
Treatment difference (8.3% [95% CI; 2.0%, 14.6%]) was driven primarily by rates of discontinuation due to AEs (4% for the regimen with TIVICAY vs 14% for efavirenz/TDF/FTC)

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

While there were no detectable decreases in susceptibility to dolutegravir or background NRTIs (ABC/3TC), 2 patients with virologic failure assigned to dolutegravir had treatment-emergent G/D/E193D and G193G/E integrase substitutions at Week 84 and Week 108, respectively, and 1 subject with 275 copies/mL HIV-1 RNA had a treatment-emergent Q157Q/P integrase substitution detected at Week 242    

*Hepatitis B virus coinfection was an exclusion criterion.

†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; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; TDF=tenofovir disoproxil fumarate.

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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