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Dovato

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Rapid, powerful and durable efficacy out to 3 years in treatment-naïve patients

DOVATO Non-inferior to DTG + TDF/FTC1

decline in Viral load graph

Adapted from Cahn et al, 2022.1

DOVATO VIROLOGICAL SUPPRESSION

RAPID

72% at Week 4

POWERFUL

91% at Week 48

DURABLE

82% at 3 Years

* these percentages relate to the % of patients with HIV-1 RMA< 50cps/mL (ITT-E)

DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
ITT–E=intent-to-treat–exposed.

Durable suppression, including people living with hiv with >500,000 copies/ml

Virological Outcomes by Baseline Viral Load at 3 Years (Pooled Analysis)2

Virological Outcomes by Baseline Viral Load at 3 Years

Adapted from Orkin et al, 2021.2

DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
*2% of participants in each arm had baseline HIV-1 RNA ≥500,000 copies/mL and were included in the analysis.3

Virological outcomes by demographic and baseline characteristics at 3 years

Virological Outcomes Across Subgroups at 3 Years2,4

Virological Outcomes Across Subgroups at 3 years

Adapted from Orkin et al, 2021 and Spinelli et al, 2021.2,4

DTG 50 mg + 3TC 300 mg used in the GEMINI studies.

  • Document Icon GEMINI-1 and GEMINI-2 Study Design

    Two fully powered clinical trials with more than 1,400 treatment-naïve patients combined

    Phase III Identically Designed, Double-Blind, Parallel-Group, Multicentre Non-inferiority Studies1,3

    study design graph
    study design graph

    DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
    ITT–E=intent-to-treat–exposed

Overall adverse event profiles were comparable across both arms1

Patients on dovato: significantly lower rate of drug-related adverse events vs dtg + tdf/ftc at 3 years*

adverse events table
adverse events table

Adapted from Cahn et al, 2022.1

DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
AE=adverse event.
*The relative risk ratio (95% CI) for DOVATO vs DTG + TDF/FTC was 0.76 (0.63, 0.92).
†Overall, 4 deaths occurred (3 in the DOVATO group and 1 in the DTG + TDF/FTC group), and all were considered unrelated to the study drug regimen.

  • Document Icon Baseline Characteristics

    Proven in a diverse patient population5

    baseline characteristics table

    Adapted from Cahn et al, 2019.5

    DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
    *Includes American Indian/Alaskan Native, Multiracial and Hawaiian or Pacific Islander.

References:

  1. Cahn P, Sierra Madero J, Arribas JR, et al. Three-year durable efficacy of dolutegravir plus lamivudine in antiretroviral therapy-naïve adults with HIV-1 infection. AIDS. 2022;36(1):39-48. doi:10.1097/QAD.0000000000003070
  2. Orkin C, Porteiro N, Berhe M, et al. Durable efficacy of DTG + 3TC in GEMINI-1 & -2: year 3 subgroup analyses. Presented at: Conference on Retroviruses and Opportunistic Infections; March 6-10, 2021; Virtual. Slides 1991.
  3. Cahn P, Sierra Madero J, Arribas JR, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection—3-year results from the GEMINI studies. Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Poster P018.
  4. Spinelli F, Prakash M, Slater J, et al. Durable efficacy and safety of DTG + 3TC in treatment-naïve people with HIV-1 stratified by age: 144-week results from GEMINI-1 and -2. Presented at 18th European AIDS Conference: October 27-30, 2021; London, England. Poster P32/60.
  5. Cahn P, Sierra Madero J, Arribas JR, et al; for the GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve 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. doi:10.1016/S0140- 6736(18)32462-0

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: May 2024 PM-IE-DLL-WCNT-200025