TEST AND TREAT

TREATMENT-NAÏVE PATIENTS

STAT Study

STAT study design

DOVATO as a First-line Regimen in a Test-and-Treat Setting

 

STAT study baseline characteristics

Diverse, Newly Diagnosed Population Including Patients With Baseline Viral Load >1 Million copies/mL1

These tables show which baseline characteristics were known at the initiation of treatment (such as age, sex, ethnicity and race) and which were unknown (such as viral load, CD4+ T-cell count, HBV and the presence of M184V resistance mutation) in the STAT study.
These tables show which baseline characteristics were known at the initiation of treatment (such as age, sex, ethnicity and race) and which were unknown (such as viral load, CD4+ T-cell count, HBV and the presence of M184V resistance mutation) in the STAT study.

Adapted from Rolle et al, 20201

  • Efficacy and resistance

    DOVATO: Confidence for your patients in a test-and-treat setting

    Powerful Efficacy and High Barrier to Resistance at Week 241

    This bar graph shows the virological outcomes irrespective of treatment and for patients on DOVATO at Week 24 in the STAT study.
    There was 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/mL

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

This bar graph shows the virological outcomes by baseline viral load or CD4+ T-cell count at 24 weeks. DOVATO demonstrates power across baseline viral loads.

Adapted from Rolle et al, 20201

*One (<1%) patient had missing plasma HIV-1 RNA results at baseline.1
Of the 19 patients 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

 

There were 0 discontinuations due to lack of virological efficacy.

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-1 RNA <50 copies/mL1

This table shows information about ART adjustments such as the reason for switch, time of switch, modified ART and viral load at 24 weeks.

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
||Patient switched ART twice.1

  • Tolerability

    A Tolerability Profile You Expect From DTG and 3TC1

    ALT

    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 bacteremia). No fatal SAEs occurred.1

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.  https://clinicaltrials.gov/ct2/show/NCT03945981 Last accessed February 24, 2021.

PM-GB-DLL-WCNT-210004 I April 2021