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Dovato

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Test and Treat

Treatment-naïve patients

STAT Study Logo
STAT Study Logo

STAT Study Design

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    DOVATO As A First-Line Regimen In a Test-And-Treat Setting

    STAT Study: Phase IIIb, Multicentre, Open-Label, Single-Arm, 52-Week Pilot Study Assessing the Feasibility, Efficacy and Safety in Newly Diagnosed Adults1,2

    A graph showing the product at week 24 as a first-line regiment in a test-and-treat setting A graph showing the product at week 24 as a first-line regiment in a test-and-treat setting
    • Single-arm pilot study in which patients started DOVATO within 14 days of HIV-1 diagnosis without the availability of screening/baseline lab results.

    STAT Study Baseline Characteristics

    Diverse, Newly Diagnosed Population Including Patients With Baseline Viral Load >1 Million copies/mL

    STAT study baseline characteristics graphs STAT study baseline characteristics graphs
    STAT study baseline characteristics graphs STAT study baseline characteristics graphs

    Adapted from Rolle et al, 2020.1

Efficacy and Resistance

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    DOVATO: Confidence For Your Patients In A Test-And-Treat Setting

    Powerful Efficacy and High Barrier to Resistance at Week 24

    Virological Outcomes at Week 24 graph Virological Outcomes at Week 24 graph

    Adapted from Rolle et al, 2020.1

    • 0 Treatment-Emergent HIV-1 or HBV Resistance

    ITT-E Missing = Failure analysis (proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 24, regardless of ART Regimen).1
    * Proportion of participants with plasma HIV-1 RNA <50 copies/mL, regardless of ART regimen, among those with available HIV-1 RNA at Week 24.1
    † Proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 24, regardless of ART regimen.1
    ‡ Proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 24 still taking DOVATO.1

    Powerful Efficacy Across Baseline Viral Loads, Including Those With >1 Million copies m/L

    Virological Outcomes by Baseline Viral Load or CD4+ T-Cell Count at 24 Weeks (ITT-E Missing = Failure Analysis)1

    virological outcomes by baseline viral load or CD4+ T-cell count at 24 weeks graph virological outcomes by baseline viral load or CD4+ T-cell count at 24 weeks graph

    Adapted from Rolle et al, 2020.1

    * One (<1%) patient had missing plasma HIV-1 RNA results at baseline.1
    † Of the 19 participants with baseline viral load ≥500,000 copies/mL, 13 (68%) were suppressed to <50 copies/mL, 4 remained on study with viral load >50 copies/mL (3 <200 copies/mL), and 2 discontinued.1

Virological Outcomes and Treatment Modifications

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    Confidence in DOVATO For Your Newly Diagnosed Patients In A Test-And-Treat Setting

    Summary of Virological Outcomes by Week 241

    FDA Snapshot analysis table FDA Snapshot analysis table

    Adapted from Rolle et al, 2020.1

    • 0 Discontinuations Due To Lack of Virological Efficacy

    ITT-E Snapshot analysis.

    Protecting Future Treatment Options With Few Modifications

    All participants with available data who had an ART adjustment and remained on a study at week 24 had HIV RNA <50 copies/mL1

    A table detailing ART adjustments during the study A table detailing ART adjustments during the study

    Adapted from Rolle et al, 2020.1

    One participant had a BL M184V resistance mutation; this participant achieved HIV-1 RNA <40 copies/mL at Week 7, before ART regimen adjustment.

    * Patient on study but missing data in window. Patient had HIV-1 RNA <40 copies/mL at Week 36.1
    † Patient participated in another double-blind clinical trial with a tenofovir-containing regimen; switched to either Biktarvy or Truvada + TIVICAY (dolutegravir).1
    ‡ Patient withdrew consent after switching from DOVATO.1
    § Patient withdrew consent due to relocation at Week 12.1
    II Patient switched ART twice.1

Tolerability

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    A Tolerability Profile You Expect From DTG and 3TC1

    A tolerability table detailing the AEs associated with the study A tolerability table detailing the AEs associated with the study

    Adapted from Rolle et al, 2020.1

    AE= adverse event; SAE= serious adverse event.
    * All AEs were Grade 2.1
    † AE leading to discontinuation of DOVATO occurred (rash). The event resolved.1
    ‡ Two SAEs occurred (cellulitis, streptococcal bacteraemia). No fatal SAEs occurred.1

IAS 2021 STAT Infographic

References:

  1. Rolle C-P, Berhe M, Singh T, et al. Feasibility, efficacy and safety of using dolutegravir/lamivudine (DTG/3TC) as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV (PLWH): The STAT study. Presented at: 14th Annual American Conference for the Treatment of HIV; August 20-22, 2020; Virtual.
  2. ViiV Healthcare. Rapid test and treat dolutegravir plus lamivudine study in newly diagnosed human immunodeficiency virus (HIV)-1 infected adults. NCT03945981. ClinicalTrials.gov. Updated May 7,2020. Last Accessed: August 2023. Available at: https://clinicaltrials.gov/ct2/show/NCT03945981

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Dovato is a registered trade mark of the ViiV Healthcare group of companies or its licensor.

Date of preparation: August 2023 PM-IE-DLL-WCNT-210003