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GEMINI EFFICACY
Rapid, powerful and durable efficacy out to 3 years in treatment-naïve patients
DOVATO Non-inferior to DTG + TDF/FTC1
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
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
Adapted from Orkin et al, 2021 and Spinelli et al, 2021.2,4
DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
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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
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
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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Baseline Characteristics Proven in a diverse patient population5
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:
- 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
- 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.
- 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.
- 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.
- 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
