SINGLE STUDY

SINGLE is a Phase 3, multicentre, randomised, double-blind, non-inferiority study involving treatment-naïve participants with HIV (N=833).

The study was designed to assess the efficacy and safety of DTG + ABC/3TC vs EFV/FTC/TDF. Primary analysis occurred at Week 48. The trial continued with a secondary analysis at Week 96. A protocol amendment added an open-label phase to both treatment groups from Week 96 to Week 144 to collect long-term efficacy and safety data.1,2

Study design:1,2
Single study design illustration
Primary endpoint:1,2

Proportion with HIV-1 RNA <50 copies/mL at Week 48, as determined with FDA snapshot analysis (-10% non-inferiority margin with pre-specified tests for superiority).

Results/outcomes:1,2
  • DTG + ABC/3TC had statistically superior efficacy vs EFV/TDF/FTC
    • 88% vs 81% were undetectable at 48 weeks (P=0.003)
    • 80% vs 72% remained subsequently undetectable at 96 weeks (P=0.006)
    • 71% vs 63% remained subsequently undetectable at 144 weeks (P=0.010)
  • DTG + ABC/3TC demonstrated rapid suppression of viral load vs EFV/TDF/FTC (28 days vs 84 days, respectively; P<0.0001)
  • DTG + ABC/3TC is effective regardless of baseline viral load
    • 83% of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at 48 weeks
    • DTG + ABC/3TC was still as effective as EFV/TDF/FTC in patients with high baseline viral loads at 96 weeks
    • 69% of treatment-naïve patients with HIV-1 RNA >100,000 copies/mL remained undetectable at 144 weeks
  • No INI or NRTI resistance was seen with DTG up to 144 weeks
  • DTG + ABC/3TC was generally better tolerated vs EFV/TDF/FTC, with fewer discontinuations
    • 2% vs 10% discontinued due to AEs at 48 weeks
    • 3% vs 11% discontinued due to AEs at 96 weeks
    • 4% vs 14% discontinued due to AEs at 144 weeks

References:

  1. Walmsley S, et al. N Engl J Med. 2013;369:1807–1818.
  2. Walmsley S, et al. J Acquir Immune Defic Syndr. 2015;70(5):515–519.
DOVATO (Dolutegravir/lamivudine)

Dolutegravir (DTG)

Dolutegravir (DTG) has been studied across diverse patient populations as part of both 3-drug and 2-drug regimens, including patients who are virologically suppressed, treatment-experienced or treatment-naïve.

Read more

PM-GB-DLL-WCNT-210002 | April 2021

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.