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PROVEN EFFICACY IN >6,000 PLHIV

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PROVEN EFFICACY IN A TEST-AND-TREAT SETTING

Virological Outcomes at Week 48[1]

The bar graph shows the virological outcomes irrespective of treatment and for patients on DOVATO at Week 48 in the STAT study.
The bar graph shows the virological outcomes irrespective of treatment and for patients on DOVATO at Week 48 in the STAT study.

Adapted from Rolle et al, 2021.[1]

ITT–E=intent-to-treat–exposed.
*Proportion of participants with plasma HIV-1 RNA <50 copies/mL, regardless of ART regimen, among those with available HIV-1 RNA at Week 48.
†Proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 48, regardless of ART regimen.
‡Proportion of all participants with plasma HIV-1 RNA <50 copies/mL at Week 48 still taking DOVATO.

Summary of Virological Outcomes at Week 48[2]

This table shows the summary of virological outcomes for STAT, including rates of HIV-1 RNA <50 copies/mL, discontinuations for lack of efficacy, discontinuations for other reasons, change in ART and no virological data.
This table shows the summary of virological outcomes for STAT, including rates of HIV-1 RNA <50 copies/mL, discontinuations for lack of efficacy, discontinuations for other reasons, change in ART and no virological data.

Adapted from Rolle et al, 2021.[2]

ROBUST EFFICACY, EVEN IN PLHIV WITH >1 MILLION copies/mL

Virological Outcomes by Baseline Viral Load or CD4+ T-cell Count at 48 Weeks (ITT–E Missing=Failure Analysis; Accounts for Patients Who May Have Switched Regimens)[1]

This table shows the virological outcomes by baseline viral load and CD4+ T-cell count.
This table shows the virological outcomes by baseline viral load and CD4+ T-cell count.

Adapted from Rolle et al, 2021.[1]

ITT–E=intent-to-treat–exposed.
*One (<1%) participant had missing plasma HIV-1 RNA results at baseline.

  • Study Design

    DOVATO AS FIRST-LINE REGIMEN IN A TEST-AND-TREAT SETTING

    STAT Study: Phase Iiib, Multicentre, Open-Label, Single-Arm, 52-Week Pilot Study Assessing Feasibility, Efficacy and Safety in Newly Diagnosed Adults[1]

    Study design chart depicting the trial of 131 patients from Screening/Day 1 through Week 52, including the primary endpoint and the key secondary efficacy analysis: the proportion of patients with plasma HIV-1 RNA <50 copies at Week 24 and Week 48, respectively.
    Study design chart depicting the trial of 131 patients from Screening/Day 1 through Week 52, including the primary endpoint and the key secondary efficacy analysis: the proportion of patients with plasma HIV-1 RNA <50 copies at Week 24 and Week 48, respectively.

    ITT–E=intent-to-treat–exposed
    *Dovato is not recommended for use in patients with creatinine clearance < 50mL/min for GB. Dovato (dolutegravir/lamivudine) Summary of Product Characteristics (SmPC)

  • Baseline Characteristics

    NEWLY DIAGNOSED PATIENTS WITH NO LAB RESULTS AT TREATMENT INITIATION

    Baseline Characteristics Known at Treatment Initiation[3]

    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.

    Baseline Characteristics Unknown at Treatment Initiation[3]

    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.

    Baseline Characteristics Known at Treatment Initiation[3]

    Baseline Characteristics Unknown at Treatment Initiation[3]

    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, 2021. [3]

    *One (<1%) participant had missing plasma HIV-1 RNA results at baseline.
    †Lower limit of quantification is <40 copies/mL.
    ‡Lower limit of quantification is <20 copies/mL.
    §Baseline resistance was identified at Week 4 and HBV co-infection was identified at Week 1 from samples taken at baseline.
    ||Two participants with HBV co-infection remained on DOVATO.

A TOLERABILITY PROFILE YOU EXPECT FROM DOVATO[1]

This table shows the reported adverse events for patients in the STAT study through 48 weeks.
This table shows the reported adverse events for patients in the STAT study through 48 weeks.

Adapted from Rolle et al, 2021.[1]

AE=adverse event; SAE=serious adverse event.
*All AEs were Grade 2.
†Two SAEs occurred (cellulitis, streptococcal bacteraemia). No fatal SAEs occurred.
‡All psychiatric AEs were Grade 1 or Grade 2. AEs were coded using MedDNA v23.1.

This chart for real-world evidence shows that there were low rates of discontinuations due to adverse events for patients who switched to DOVATO across 7 real-world studies.

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References:

  1. Rolle C-P, Berhe M, Singh T, et al. High results of virologic suppression with DTG/3TC in newly diagnosed adults with HIV-1 infection and baseline viral load ≥500,000 c/mL: 48-week subgroup analysis of the STAT study. Presented at: IDWeek 2021; September 29-October 3, 2021; Virtual.
  2. Rolle C-P, Berhe M, Singh T, et al. Feasibility, efficacy, and safety of dolutegravir/lamivudine (DTG/ 3TC) as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV (PLWH): 48-week results of the STAT study. Presented at: The 11th International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Poster PEB182.
  3. Rolle C-P, Berhe M, Singh T, et al. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021;35(12):1957-1965. doi:10.1097/QAD.0000000000002979

October 2022 PM-GB-DLL-WCNT-220004

Prescribing Information

Adverse event reporting

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.

If you are from outside the UK, you can report adverse events to GSK/ViiV by selecting your region and market, here.