Tango study

TANGO is an ongoing, open-label, multicentre, Phase 3 non-inferiority study enrolling virologically suppressed adults living with HIV-1 (N=741).

TANGO was designed to evaluate the efficacy and safety of switching to DTG/3TC vs remaining on a TAF-based regimen. Study visits were planned for baseline, every 4 weeks through Week 12 and every 12 weeks thereafter. 1

Study design:1
Tango study design illustration
Primary endpoint:1

Proportion of patients with HIV-1 RNA ≥50 copies/mL virological failure, as determined with the FDA snapshot analysis algorithm at Week 48 in the ITT-E population (4% non-inferiority margin).

Results/outcomes:1,2
  • DTG/3TC was non-inferior at maintaining virologic suppression vs a TAF-based regimen at the 48 week primary endpoint and through 96 weeks
    • At Week 96, <1% (1/369) of participants with HIV-1 RNA had ≥50 c/mL in the DTG/3TC group vs 1% (4/372) in the TAF containing regimen
    • In the per-protocol population, superiority was demonstrated with 0/348 participants in the DTG/3TC group and 4/351 (1%) in the TAF-based regimen group with HIV-1 RNA ≥50 c/mL at Week 96 (adjusted difference, –1.1%; 95% CI, –2.3% to –0.0%)
  • No confirmed virologic withdrawals in the DTG/3TC group through 96 weeks compared with 3/373 in the TAF containing regimen
    • No cases of resistance-associated mutations were reported in either treatment group
  • The safety profile of DTG/3TC was consistent with the DTG and 3TC labels
    • Rates of AEs occurring after Week 48 were similar in both treatment groups

References:

  1. Van Wyk J, et al. Clin Infect Dis. 2020;71(8): 1920–1929
  2. Van Wyk J, et al. HIV Drug Therapy. Presented at: HIV Glasgow 2020. October 5–8, 2020, Virtual. Slides O441
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.