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

Dovato

Product menu

Powerful, Durable Efficacy

Treatment-naïve patients

Power Reimagined

GEMINI-1 & GEMINI-2 Study Design

  • Expand to See More

    2 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
    2 Fully Powered Clinical Trials with more than 1,400 Treatment-naïve patients combined 2 Fully Powered Clinical Trials with more than 1,400 Treatment-naïve patients combined

    GEMINI-1 & GEMINI-2 Baseline Characteristics2

    gemini-baseline

    Adapted from Cahn et al, 2019.2

    • 20% of patients on DOVATO had baseline viral loads >100,000 copies/mL.2
    • 2% of patients in both arms had viral loads of ≥500,000 copies/mL at baseline after screening.2

    *includes American Indian/Alaskan Native, Multiracial and Hawaiian or Pacific Islander.2

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

Rapid, Powerful and Durable Efficacy out to 3 years in Treatment-Naïve Patients

Dovato non-inferior to DTG + TDF/FTC at 144-weeks1
Rapid, Powerful and Durable Efficacy out to 3 years in Treatment-Naïve Patients Rapid, Powerful and Durable Efficacy out to 3 years in Treatment-Naïve Patients

Adapted from Cahn et al, 2020.1

Additional Efficacy Datapoints (48- & 96-Weeks):

Durable suppression across viral load strata

Virological Outcomes by Baseline Viral Load at 96-Weeks (ITT-E Pooled Analysis) 3,4

Durable suppression across viral load strata Durable suppression across viral load strata

Adapted from van Wyk et al, 2019 and Cahn et al, 2020.3,4

*2% of patients in each arm had baseline HIV-1 RNA >500,000 copies/mL and were included in the ITT-E analysis.4

Rapid viral load decline in patients with high viral loads.

Magnitude and speed of viral load decline comparable to DTG + TDF/FTC, irrespective of baseline viral load.6

Rapid viral load decline in patients with high viral loads. Rapid viral load decline in patients with high viral loads.

Adapted from Eron et al. 2018.6

* Median time to virological suppression was 29 days for all patients across both arms.

Efficacy by subgroups generally consistent with overall study results at 96-weeks

Proportion of patients with plasma HIV-1 RNA <50 copies/mL at week 96.3

Efficacy by subgroups generally consistent with overall study results at 96-weeks Efficacy by subgroups generally consistent with overall study results at 96-weeks

Adapted from Cahn et al. 2020.3

* Median time to virological suppression was 29 days for all patients across both arms.

Virological Outcomes by Baseline CD4+ T-Cell Count Strata at 96-Weeks3,5

  • ITT-E: >200 cells/mm3 DOVATO 88% (573/653) vs DTG + TDF/FTC 90% (594/622)
    • When treatment-related discontinuation = failure (TRDF)* analysis is applied: >200 cells/mm3 DOVATO 97% (633/653) vs DTG + TDF/FTC 96% (638/662)
  • ITT-E: ≤ 200 cells/mm3 DOVATO 68% (43/63) vs DTG TDF/FTC 87% (48/55)
    • When TRDF analysis is applied: ≤200 cells/mm3 DOVATO 93% (59/63) vs DTG + TDF/FTC 96% (53/55)

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. Cahn P, Sierra Madero J, Arribas JR, et al. 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-bind, randomised, non-inferiority, phase 3 trials. Lancet. 2019;393(10167):143-155.
  3. Cahn P, Sierra Madero J, Arribas JR, et al. Durable efficacy of dolutegravir plus lamivudine in antiretroviral treatment-navie adults with HIV-1 infection: 96-week results from the GEMINI-1 and GEMINI-2 randomized clinical trials. J Acquired Immune Defic Syndr. 2020;83 (3):310-318.
  4. van Wyk J, Man C, Sievers J, et al. Durable efficacy of two-drug regimen of DTG + 3TC in antiretroviral treatment-naïve adults with HIV-1 infection at 96 weeks: subgroup analyses in the GMEINI studies. Presented at IDWeek: Octtober 2-6, 2019;Washington, DC. Slides 2842.
  5. Cahn, P, Sierra Madero J, Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in an antiretroviral treatment-naïve adults with HIV-1 infection: 96-week results from the GEMINI studies. Presented at: International AIDS conference; July 21-24, 2019; Mexico city, Mexico. Slides WEAB0404LB.
  6. Eron J, Hung C-C, Baril J-G, et al. Initial viral load decline and response rates by baseline viral load strata with dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate /emtricitabine: pooled results from the GEMINI studies. Presented at: HIV DART and Emerging Viruses: November 27-29, 2018; Miami, FL.

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-200025