Virologically suppressed HIV: DTG/3TC shows efficacy, noninferiority to TAF-based regimens

  • van Wyk J & al.
  • Clin Infect Dis
  • 06/01/2020

  • Liz Scherer
  • Clinical Essentials
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Takeaway

  • 2-drug fixed-dose combination (dolutegravir [DTG]+lamivudine [3TC]) is noninferior to a 3- or 4-drug tenofovir alafenamide (TAF)-based regimen through 48 weeks in HIV-infected, virologically suppressed adults with no prior virologic failures or known resistance mutations. 

Why this matters

  • DTG/3TC can be considered an effective switch option for virologically suppressed, HIV-infected patients.
  • Familiarity with European AIDS Clinical Society switch strategies guidelines is recommended.

Key results

  • 743 participants; 371 switched to DTG/3TC.
  • Week 48:
    • 0.3% (1) DTG/3TC vs 0.5% (2) TAF had HIV-1 RNA ≥50 copies/mL.
    • Per-protocol population: 0 DTG/3TC vs 0.6% TAF had HIV-1 RNA ≥50 copies/mL.
      • Adjusted treatment difference (aTD): −0.6 (95% CI, −1.3 to 0.2).
    • 93.2% (344) DTG/3TC vs 93.0% (346) TAF had HIV-1 RNA
    • aTD: 0.2 (95% CI, −3.4 to 3.9).
  • 0 DTG/3TC vs 1 TAF met confirmed virologic withdrawal criteria. 
  • No emergent resistance observed.
  • Grade 1/2 adverse events (AEs) seen in 0.8% (3) DTG/3TC vs 1.6% (6) TAF.
  • Withdrawal-related AEs in 3.5% (13) DTG/3TC vs 0.5% (2) TAF. 
  • Study design

    • Week 48 analysis of DTG/3TC switch strategy in HIV-infected, virologically suppressed adults enrolled in an open-label, multicenter, phase 3 noninferiority trial (TANGO).
    • Funding: ViiV Healthcare.

    Limitations

    • Limited generalizability.
    • Open-label. 
    • Withdrawal bias.