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)

Dovato_Charts_Mobile Rev 11ai
Dovato_Charts_Mobile Rev 11ai

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

AS EFFECTIVE
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

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.

Powerful Results With Durable Virologic Suppression at 96 Weeks

Prespecified Secondary Endpoint—Noninferior to DTG + TDF/FTC at 96 Weeks2,3

GEMINI 1 & 2—Pooled Virologic Response (ITT-E; snapshot analysis)

Efficacy_96WK_LineGraph_ITTE
Efficacy_96WK_LineGraph_ITTE

Powerful Results Include Data in High Viral Loads at 96 Weeks

GEMINI 1 & 2—Pooled Virologic Success Rates Stratified by Baseline Viral Load Subgroup at Week 962,3*

viral_loads
viral_loads

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

  • HIV-1 RNA ≥50 copies/mL: DOVATO, 3.1%; DTG + TDF/FTC, 2.0%
  • No virologic data: DOVATO, 10.9%; DTG + TDF/FTC, 8.5%
     

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).

ITT-E==Intent-to-treat–exposed.

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.
  3. 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.

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