GEMINI-1 & GEMINI-2 Study Design
Phase III, Identically Designed, Double-Blind, Parallel-Group, Multicentre Non-Inferiority Studies1
GEMINI-1 & GEMINI-2 Baseline Characteristics2
*Includes American Indian/Alaskan Native, Multiracial and Hawaiian or Pacific Islander.²
Adapted from Cahn et al, 2020. 1
RapId, Powerful and Durable EffIcacy
DOVATO Non-inferior to DTG + TDF/FTC at Week 1441
Adapted from Cahn et al, 2020.1
DURABLE SUPPRESSION OUT TO week 144—INCLUDING PATIENTS WITH HIGH BASELINE VIRAL LOADS
Virological Outcomes by Baseline Viral Load at 144 weeks (ITT-E Pooled Analysis)1
*2% of participants in each arm had baseline HIV-1 RNA ≥500,000 copies/mL and were included in the ITT–E analysis.¹
RAPID VIRAL LOAD DECLINE IN PATIENTS WITH HIGH VIRAL LOADS
Adapted from Eron et al, 2018. 3
VIROLOGICAL OUTCOMES BY BASELINE CD4+T-CELL COUNT STRATA AT 144¹ WEEKS
- ITT–E: >200 cells/mm³ DOVATO 83% (542/653) vs DTG + TDF/FTC 84% (557/662)
- ITT–E: ≤200 cells/mm³ DOVATO 67% (42/63) vs DTG + TDF/FTC 76% (42/55)
DTG 50 mg + 3TC 300 mg used in the GEMINI studies.
- 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.
- 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
- 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. Slides 7.
PM-GB-DLL-WCNT-210004 I April 2021