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.
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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