Efficacy

Delivers the Power of a DTG-Based 3-Drug Regimen

Primary Endpoint Results: Noninferior to Comparator at Week 481,2

Proportion of Patients, %

Proportion of Patients, %

  • No virologic data: 6%, DOVATO; 6%, DTG + TDF/FTC
  • Noninferior treatment difference: –2.6 (95% CI; –6.7, 1.5)
  • No virologic data: 5%, DOVATO; 4%, DTG + TDF/FTC
  • Noninferior treatment difference: –0.7 (95% CI; –4.3, 2.9)

Rapid and Sustained Virologic Suppression

Results Noninferior to DTG + TDF/FTC at Week 481,2

GEMINI 1 & 2 - POOLED VIROLOGIC RESPONSE BY VISIT (ITT-E; SNAPSHOT ANALYSIS)

Patients With HIV-1 RNA <50 copies/mL, %

The evaluation of antiviral activity over time was a prespecified secondary endpoint, ITT-E population.

  • 89% of patients were virologically suppressed by Week 122

DTG=dolutegravir; FTC=emtricitabine; ITT-E=intent-to-treat–exposed; TDF=tenofovir disoproxil fumarate.

Powerful Results Include Data in High Viral Loads

GEMINI 1 & 2—Pooled Virologic Success Rates Stratified by Baseline Viral Load Subgroup at Week 481

Patients With HIV-1 RNA <50 copies/mL, %

Patients With HIV-1 RNA <50 copies/mL, %

Subgroup analysis by baseline viral load was a prespecified secondary endpoint, ITT-E population.

Virologic Response By Baseline CD4+ T-Cell Count

GEMINI 1 & 2—Virologic Response by Baseline CD4+ T-Cell Count in ITT-E Pooled Subgroup at Week 481

Patients With HIV-1 RNA <50 copies/mL, %

Subgroup analysis by baseline viral load was a prespecified secondary endpoint, ITT-population.

See reasons for nonresponse below.

Adjusted mean change in CD4T-cell count from baseline at Week 48:

  • DOVATO: 224 cells/mm3
  • DTG + TDF/FTC: 217 cells/mm3

GEMINI 1 & 2—Reasons for Snapshot Nonresponse in the Subgroup With Baseline CD4+ T-Cell Count ≤200 cells/mm3 (pooled analysis)1 

  DOVATO (n=63) DTG + TDF/FTC (n=55)
Confirmed virologic withdrawal*
1 0
HIV-1 RNA ≥50 copies/mL
3 1
Discontinued due to nontreatment-related AE    
2
0
Protocol violations    
2 0
Lost to follow-up    
2 1
Withdrew consent    
1 1
Withdrew to start HCV treatment    
1 0
Unplanned change in ART    
1§
0
Investigator discretion    
0 1
Total, n 13 4

References:

1. Cahn P, Sierra Madero J, Arribas J, et al; and GEMINI study team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155.

2. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.

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