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PROVEN EFFICACY IN >6,000 PLHIV

GEMINI-1
GEMINI-2

RAPID, POWERFUL AND DURABLE EFFICACY OUT TO 144 WEEKS IN TREATMENT-NAÏVE PATIENTS

DOVATO Non-inferior to DTG + TDF/FTC[1]

This line graph shows the proportion of patients with HIV-1 RNA <50 copies/mL by visit through 144 weeks. DOVATO was non-inferior to the comparator arm, DTG + TDF/FTC at 144 weeks.
This line graph shows the proportion of patients with HIV-1 RNA <50 copies/mL by visit through 144 weeks. DOVATO was non-inferior to the comparator arm, DTG + TDF/FTC at 144 weeks.

Adapted from Cahn et al, 2022.[1]

DOVATO Virological Suppression

RAPID

72% at Week 4

POWERFUL

91% at Week 48

DURABLE

82% at Week 144

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

DURABLE SUPPRESSION, INCLUDING PLHIV WITH >500,000 COPIES/ML

Virological Outcomes by Baseline Viral Load at 144 weeks (Pooled Analysis)[2]

This bar graph shows the proportion of patients with HIV-1 RNA <50 copies/mL at 144 weeks stratified by baseline viral load from ≤100,000 copies/mL to >500,000 copies/mL.
This bar graph shows the proportion of patients with HIV-1 RNA <50 copies/mL at 144 weeks stratified by baseline viral load from ≤100,000 copies/mL to >500,000 copies/mL.

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 144 WEEKS

Virological Outcomes Across Subgroups at 144 weeks[2,4]

This bar graph shows the proportion of patients with HIV-1 RNA <50 copies/mL at 144 weeks stratified by age, sex, race and baseline CD4+ T-cell count (cells/mm3).
This bar graph shows the proportion of patients with HIV-1 RNA <50 copies/mL at 144 weeks stratified by age, sex, race and baseline CD4+ T-cell count (cells/mm3).

Adapted from Orkin et al, 2021 and Spinelli et al, 2021.[2,4]

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

  • 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 Studies[1,3]

    This study design chart shows GEMINI-1 and GEMINI-2 were Phase III, identically designed, double-blind, parallel-group, multicentre, non-inferiority studies in more than 1,400 treatment-naïve adult patients. Study arms included DOVATO (DTG + 3TC) and DTG + TDF/FTC.
    This study design chart shows GEMINI-1 and GEMINI-2 were Phase III, identically designed, double-blind, parallel-group, multicentre, non-inferiority studies in more than 1,400 treatment-naïve adult patients. Study arms included DOVATO (DTG + 3TC) and DTG + TDF/FTC.

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

  • Baseline Characteristics

    CONFIDENCE IN TREATING A DIVERSE POPULATION[5]

    This baseline characteristics table shows the characteristics (including age, sex, race, ethnicity, viral load and CD4+ T-cell count) were similar across both treatment arms.
    This baseline characteristics table shows the characteristics (including age, sex, race, ethnicity, viral load and CD4+ T-cell count) were similar across both treatment arms.

    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.

OVERALL ADVERSE EVENT PROFILES WERE COMPARABLE ACROSS BOTH ARMS

This table shows that the adverse events were comparable across both arms out to 144 weeks in GEMINI-1 and GEMINI-2.
This table shows that the adverse events were comparable across both arms out to 144 weeks in GEMINI-1 and GEMINI-2.

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.

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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

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 www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline 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.