HIV: 2-drug regimen as good as triple-hit in ART-naive adults

  • Cahn P & al.
  • Lancet
  • 9 Nov 2018

  • curated by Emily Willingham, PhD
  • Medical News
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Takeaway

  • 2-drug therapy with dolutegravir plus lamivudine shows noninferior efficacy vs 3-drug dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in adults with HIV-1 who have not initiated antiretroviral therapy (ART).
  • Results from GEMINI-1 and GEMINI-2 suggest similar tolerability of 2-drug regimen, also.

Why this matters

  • Accompanying editorial says results suggest 2-drug regimens could become reliable drug-sparing options and pose a “high genetic barrier” at least for 48 weeks.
  • 96-week results are forthcoming.  

Key results

  • GEMINI-1, intention-to-treat-exposed population, plasma HIV-1 RNA
  • 90% with 2-drug regimen.
  • 93% with 3-drug regimen.
  • Adjusted treatment difference: −2.6% (95% CI, −6.7% to 1.5%).
  • In GEMINI-2, plasma HIV-1 RNA
  • 93% with 2-drug regimen.
  • 94% with 3-drug regimen.
  • Adjusted treatment difference: −0.7% (95% CI, −4.3 to 2.9).
  • More drug-related adverse events with 3-drug (24% vs 18% with 2-drug).
  • Study design

    • GEMINIs are identical randomized, placebo-controlled, double-blind phase 3 trials; 192 centers, 21 countries.
    • Participants ≥18 years, HIV-1 infection, HIV-1 RNA ≤500,000 copies/mL, no prior ART; 719 in 2-drug group; 722 in 3-drug.
    • Primary endpoint: proportion with  
    • Funding: ViiV Healthcare.

    Limitations

    • Little low-resource country representation.
    • Largely young men

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