Studied in 2 Robust Phase 3 Clinical Trials1
GEMINI 1 & 2 (pooled)
*Patients received 1 dolutegravir 50-mg tablet and 1 lamivudine 300-mg tablet once daily.
- Treatment naïve
- ≥18 years old
- HIV-1 RNA 1000 copies/mL to ≤500,000 copies/mL at screening
- CrCl ≥50 mL/min
- HBV negative
- No evidence of major resistance-associated mutations (less than 1% of screened patients had a M184V mutation at baseline and were excluded)1,2
Primary Endpoints (GEMINI 1 & 2)
- The proportion of patients with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot analysis with 10% noninferiority margin
CrCl=creatinine clearance; DTG=dolutegravir; FTC=emtricitabine; HBV=hepatitis B virus; TDF=tenofovir disoproxil fumarate.
Pooled Baseline Characteristics From GEMINI 1 & 21
DTG + TDF/FTC
|Median age||32 years||33 years|
|African American or African heritage
|HIV-1 RNA >100,000 copies/mL†||20%||21%|
|CD4+ T-cell count >200 cells/mm3||91%||92%|
|CDC Stage 3 (AIDS)||9%||8%|
140 patients on DOVATO had high baseline viral loads >100,000 copies/mL
†2% of participants in each arm had baseline HIV-1 RNA >500,000 copies/mL.
CDC=Centers for Disease Control and Prevention; HCV=hepatitis C virus.
1. Cahn P, Sierra Madero J, Arribas J, et al; and GEMINI Study Team. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive 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.
2. Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.