For treatment-naïve adults with HIV-1. See Full Indication.
Clinical Trials For dovato
The clinical trials for DOVATO—GEMINI 1 & 2—were performed at 192 centers in 21 countries. The primary objective of the studies was to evaluate the efficacy and safety of DOVATO, a two-drug regimen, compared with the three-drug regimen of DTG + TDF/FTC for treatment of HIV-1 infection in ART-naïve adults. Healthcare professionals are encouraged to explore the results in detail by accessing the information below.
Studied in 2 Robust Phase 3 Clinical Trials1
GEMINI 1 & 2 (pooled)
*Open label phase from 96 weeks to 144 weeks.
†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 (<1% of screened patients had a M184V/I mutation at baseline and were excluded)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||9%||8%|
|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.
- 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.
- Data on file. ViiV Healthcare group of companies. Research Triangle Park, NC.