You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site.

Continue

Go back

High Barrier to Resistance

Treatment-Naïve Patients

GEMINI Logo

Few Confirmed Virological Withdrawals* at 3 Years¹

Few Confirmed Virological Withdrawals* at 3 Years¹

resistance-table-2

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

* Patients met confirmed virological withdrawal criteria if a second and consecutive HIV-1 RNA value met any of the following definitions: decrease from baseline in HIV-1 RNA of <1 log10 copies/mL unless HIV-1 RNA of <200 copies/mL by week 12; confirmed plasma HIV-1 RNA of ≥200 copies/mL after confirmed consecutive HIV-1 RNA <200 copies/mL.

resistance
resistance resistance
  • In the GEMINI studies, participants were required to take 2 separate pills each day: DTG 50 mg and 3TC 300 mg
  • It is not known if this participant was selectively adherent (i.e. adherent to only DTG or 3TC, or to both pills) and selective adherence increases the risk of developing resistance-associated mutations
  • As DOVATO is fixed-dose combination of DTG and 3TC, the risk of selective adherence to 1 component of the regimen is eliminated*

*Patient withdrew due to lack of efficacy
^Patient regained virologic suppression

Virologically Suppressed Patients

TANGO Logo
TANGO Logo

Reassurance with a High Barrier to Resistance up to 96-Weeks

Reassurance with a High Barrier to Resistance up to 48-Weeks

NA
zero

Cases of Resistance-Associated Mutations²

No INI or NRTI Mutations Observed at Confirmed Virological Withdrawal*

resistance-table-2

* Patients met confirmed virological withdrawal criteria if they had 1 assessment with HIV-1 RNA ≥200 copies/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 copies/mL.

References:

  1. 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.
  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. DOVATO Summary of Product Characteristics. Last Accessed: August 2022. 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: August 2022 PM-IE-DLL-WCNT-200019