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Dovato

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CLINICAL TRIALS AND REAL-WORLD EVIDENCE

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For your Treatment-Naïve patients

Two fully powered clinical trials with more that 1,400 treatment-naïve patients combined. Dovato demonstrated non-inferior efficacy vs DTG + TDF/FTC in treatment-naïve patients at 144-weeks1

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For your Virologically Suppressed patients

Comparative study of Dovato vs TAF-containing regimens in more than 700 virologically suppressed patients. Dovato maintained efficacy vs TAF-containing regimens at 96-weeks2

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STAT Study

Dovato as a first-line regimen in a test-and-treat setting

Powerful efficacy and high barrier to resistance at week 243

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For your Virologically Suppressed patients

The objective of SALSA was to evaluate efficacy and safety of switching to the 2-drug regmen DTG/3TC fixed-dose combination (Dovato) compated with continuing any current 3- or 4-drug ART regmen in adults with HIV-1 over 48-weeks4

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Rumba logo

The first head-to-head clinical trial vs BIC/FTC/TAF

The RUMBA study is a randomised trial evaluating the efficacy of DOVATO vs BIC/FTC/TAF via viral reservoirs in virologically suppressed people living with HIV5

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Real-world data logo

Dovato is now being assessed in Treatment-Naïve PLHIV, whilst growing Real-World Data continue to reinforce robust efficacy in switch to Dovato

See the Real-World Evidence for both NaÏve and Switch PLHIV

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Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.6

References:

  1. Cahn P, Sierra Madero J, Arribas JR, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naive adults with HIV-1 infection - 3-year results from the GEMINI studies. Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Poster P018
  2. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 96 weeks (TANGO study). Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Slides O441.
  3. 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.
  4. Llibre JM, Alves Brites C, Cheng C-Y, et al. Switching to the 2-drug regimen of dolutegravir/lamivudine (DTG/3TC) fixed-dose combination is noninferior to continuing a 3-drug regimen through 48 weeks in a randomized clinical trial (SALSA). Presented at: International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Slides OALB0303.
  5. Vandekerckhove L, Trypsteen W, Bloome E, et al. Impact of switch towards 3TC/dolutegravir on the intact and total HIV-1 viral reservoir in the Rumba study. Presented at: HIV Glasgow 2022; October 23-26, 2022; Glasgow, UK. Slides MO42.
  6. DOVATO Summary of Product Characteristics. Last Accessed March 2021. Available at: https://www.medicines.ie/medicines/dovato-50-mg-300-mg-film-coated-tablets-34871/spc

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-200016

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