For treatment-naïve adults with HIV-1. See Full Indication.
Efficacy OF DOVATO
The virologic efficacy of DOVATO has been tested in two Phase 3 clinical trials—GEMINI 1 & 2. Detailed below are primary endpoint results as well as the results from some prespecified secondary endpoints, such as the evaluation of antiviral activity over time in the ITT-E population.
Delivers the Power of a DTG-Based 3-Drug Regimen at 48 Weeks With 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, %
as a DTG-based 3-drug regimen
Primary Endpoint Results: Noninferior to Comparator at Week 481
- GEMINI 1: 90% DOVATO (n=356); 93%, DTG + TDF/FTC (n=358); treatment difference: -2.6% (95% CI; -6.7%, 1.5%)
- GEMINI 2: 93% DOVATO (n=360); 94%, DTG + TDF/FTC (n=359); treatment difference: -0.7% (95% CI; -4.3%, 2.9%)
CI=confidence interval;DTG=dolutegravir; FTC=emtricitabine; ITT-E=intent-to-treat–exposed; TDF=tenofovir disoproxil fumarate.
Powerful Results Include Data in High Viral Loads at 48 Weeks
GEMINI 1 & 2—Pooled Virologic Success Rates Stratified by Baseline Viral Load Subgroup at Week 481
Prespecified Secondary Endpoint—Noninferior to DTG + TDF/FTC at 96 Weeks2,3
GEMINI 1 & 2—Pooled Virologic Response (ITT-E; snapshot analysis)
Summary of Virologic Outcomes
GEMINI 1 & 2—Pooled Analysis at 96 Weeks2,3
|Snapshot outcome, n (%)||DOVATO (n=717)||DTG + TDF/FTC (n=717)|
|HIV-1 RNA <50 copies/mL||616 (86.0%)||642 (89.5%)|
|HIV-1 RNA ≥50 copies/mL||22 (3.1%)||14 (2.0%)|
|No virologic data*||78 (10.9%)||61 (8.5%)|
|Discontinuation (AE or death)||22 (3%)||21 (3%)|
|Discontinuation (other reasons)†||56 (8%)||38 (5%)|
|On study but missing data in window||0||2 (<1%)|
Discontinuations (other reasons) unrelated to treatment were higher in the DOVATO arm
*In patients with no virologic data at Week 96, none had last HIV-1 RNA value >50 copies/mL except for 1 patient in the DTG + TDF/FTC group.
†Other reasons for discontinuation at Week 96 included protocol deviation, lost to follow-up, physician decision, withdrawal by patient, and lack of efficacy (in 1 patient in the DTG + TDF/FTC group).
- Cahn P, Sierra Madero J, Arribas J, et al; and GEMINI study team. Dolutegravir plus lamivudine versus
dolutegravirplus tenofovir disoproxilfumarate 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.
- Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.
- Cahn P, Madero JS, Arribas JR, et al. Durable Efficacy of Dolutegravir (DTG) Plus Lamivudine (3TC) in Antiretroviral Treatment–Naive Adults With HIV-1 Infection: 96-Week Results From the GEMINI Studies. Presented at the 10th International AIDS Society (IAS) Conference on HIV Science; July 21-24, 2019; Mexico City, Mexico. Slides WEAB0404LB.