TANGO Study: switch to DTG/3TC

Van Wyk J, IAS 2019, Abs. WEAB0403LB

Type of ARV Trial
Switch studies in virologically suppressed patients
» Switch to DTG-containing regimen
» DTG + 3TC

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  • Switching to DTG/3TC FDC was non-inferior to remaining on a TAF/FTC-based regimen through Week 48 in ART-experienced, virologically suppressed adults
  • No confirmed virologic withdrawals in the DTG/3TC group
  • Zero resistance development in the DTG/3TC group
  • Good safety profile of DTG/3TC FDC

Design


* Randomisation was stratified by 3rd agent (PI, INSTI or NNRTI)

Endpoints

  • Primary: proportion of patients with virologic failure at W48 (ITT-E, snapshot) ; non-inferiority if upper margin of the two-sided 95% CI for the difference = 4%, 90% power
  • Virologic failure: HIV-1 RNA ≥ 50 c/mL in W48 window, change of therapy, discontinuation of study treatment for lack of efficacy

Baseline characteristics and patient disposition

Virologic outcome at W48 ITT-e snapshot

  • 1 discontinuation for HIV RNA ≥ 200 c/ml (TAF/FTC arm)
  • No emergence of resistance

Adjusted difference (95% CI)

Adverse events

Renal biomarkers at W48