Stringent analysis for viral load <40 copies/mL further supports the potency of dolutegravir+ lamivudine1

At Week 48 Snapshot analysis of qualitative target detected (TD) or target–not-detected (TND)° for viral loads <40 copies/mL in patients in the GEMINI-1 and GEMINI-2 studies found:

• Dolutegravir (DTG) + lamivudine (3TC) and DTG + Tenofovir/Emtricitabine (TDF/FTC) had similar proportions of TND (viral loads<40 copies/mL) across all weeks (77% [553/716] vs 73% [525/717], respectively) and baseline viral load strata:
      • In patients with HIV-1 RNA >100,000 copies/mL at baseline, response rates were higher with DTG + 3TC vs DTG + TDF/FTC (64% [90/140] vs 52% [79/153], respectively)
      • In patients with HIV-1 RNA ≤100,000 copies/mL at baseline, response rates were similar between DTG + 3TC vs DTG + TDF/FTC (80% [463/576] vs 79% [446/564], respectively)

• Median time to TND was 57 days in both arms overall
     o In patients with HIV-1 RNA >100,000 copies/mL: DTG + 3TC 113 days vs DTG + TDF/FTC 169 days
     o In patients with HIV-1 RNA ≤100,000 copies/mL: DTG + 3TC 57 days vs DTG + TDF/FTC 57 days1

This data, utilizing a more stringent but exploratory snapshot criteria, further demonstrates the efficacy of DTG + 3TC and supports the usage of this 2-drug regimen for the treatment of HIV-1 infection.1

°Abbott Realtime assay measures quantitative HIV-1 RNA viral load (VL) from 40c/mL to 10,000,000c/mL, and generates qualitative target detected (TD) or target not detected (TND) for VL<40c/mL.  FDA snapshot algorithm uses 50c/mL as cut-off.  Clinical significance and subject management implications of low level quantitative and qualitative VL data remains controversial. 

  1. Underwood M et al., Poster 490, Presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2019; Seattle, WA

PM-GB-DLT-WCNT-190001 - March 2019