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

Primary Endpoint 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

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

AS EFFECTIVE
as a DTG-based 3-drug regimen

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)

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 plus lamivudine in antiretroviral treatment-naïve adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquir Immune Defic Syndr. 2020;83(3):310-318.
    doi: 10.1097/QAI.0000000000002275.

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