Trial Design

Studied in 2 Robust Phase 3 Clinical Trials1

 
GEMINI 1 & 2 (pooled)

  • Two ongoing, identically designed, Phase 3, randomized, parallel-group, noninferiority trials in 1433 treatment-naïve adult patients (pooled data)

 

*Patients received 1 dolutegravir 50-mg tablet and 1 lamivudine 300-mg tablet once daily.

Inclusion Criteria:

  • Treatment naïve
  • ≥18 years old
  • HIV-1 RNA 1000 copies/mL to ≤500,000 copies/mL at screening
  • CrCl ≥50 mL/min
  • HBV negative
  • No evidence of major resistance-associated mutations (less than 1% of screened patients had a M184V mutation at baseline and were excluded)1,2

Primary Endpoints (GEMINI 1 & 2)

  • The proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot analysis with 10% noninferiority margin

CrCl=creatinine clearance; DTG=dolutegravir; FTC=emtricitabine; HBV=hepatitis B virus; TDF=tenofovir disoproxil fumarate.

Pooled Baseline Characteristics From GEMINI 1 & 21

 

DOVATO
n=716

DTG + TDF/FTC
n=717

Median age 32 years 33 years
Female
16% 14%
African American or African heritage  
14% 11%
White  
67% 69%
Asian   
10% 10%
HIV-1 RNA >100,000 copies/mL     20% 21%
CD4+ T-cell count >200 cells/mm3     91% 92%
CDC Stage 3 (AIDS) 9% 8%
HCV co-infection 5% 7%

140 patients on DOVATO had high baseline viral loads >100,000 copies/mL

2% of participants in each arm had baseline HIV-1 RNA >500,000 copies/mL.

CDC=Centers for Disease Control and Prevention; HCV=hepatitis C virus.

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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