The TANGO clinical trial for DOVATO is an ongoing study to evaluate the efficacy and safety of a switch to DOVATO vs remaining on a TAF-containing regimen in virologically suppressed adults living with HIV-1.1 Healthcare professionals are encouraged to explore the results in detail by accessing the information below.
TANGO: A Robust Clinical Trial vs TAF-Containing Regimens for Virologically Suppressed Patients
Phase 3, randomized, multicenter, noninferiority switch study1,2*
From Week 148 onward, all patients were switched to DOVATO.
Once-daily DTG 50 mg/3TC 300 mg tablet.
- Virologically suppressed adults with HIV-1 RNA <50 copies/ml for >6 months
- TAF/FTC + INSTI, NNRTI, or Pl as initial regimen
- Stable 3- or 4-drug TAF-containing regimen
- No prior virological failure and no documented NRTI or INSTI resistance
- HBV negative
- No severe hepatic impairment (Child-Pugh class C)
- Efficacy and safety were assessed through 96 weeks
- 8% non-inferiority margin by Snapshot algorithm, ITT-E
3TC=lamivudine; DTG=dolutegravir; FTC=emtricitabine; HBV=hepatitis B virus; INSTI=integrase strand transfer inhibitor; ITT-E=intent-to-treat–exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; TAF=tenofovir alafenamide.
Baseline Third Agent Class, %1
TAF-CONTAINING REGIMENS INCLUDED TAF/FTC PLUS:
DTG n=41; RAL n=6.2
bDRV=boosted darunavir; EVG/c=elvitegravir/cobicistat; RAL=raltegravir; RPV=rilpivirine.
TANGO Baseline Characteristics1,2
ART=antiretroviral therapy; CDC=Centers for Disease Control and Prevention.
TANGO: 96-Week Efficacy Data
Durable Virologic Suppression Out to 96 Weeks
DOVATO was as effective as TAF-containing regimens through 96 weeks
- The number of patients with no virologic data at Week 96 due to COVID-19 was a primary driver in the treatment difference in the secondary endpoint
TANGO: 48-Week Efficacy Data
Virologic Suppression Maintained vs TAF-Containing Regimens at 48 Weeks
Patients who switched to DOVATO had no increased rate of virologic failure vs those who remained on TAF-containing regimens1
TANGO — Noninferior§ Virologic Response (ITT-E; snapshot analysis)
4% noninferiority margin for primary endpoint; –8% noninferiority margin for secondary endpoint.
TANGO: 96-Week Resistance Data
A High Barrier to Resistance Through 96 Weeks3
- Of the patients with confirmed virologic withdrawal (HIV RNA ≥50 copies/mL followed by a second consecutive HIV-1 RNA assessment ≥200 copies/mL) in both arms, none had treatment-emergent INSTI or NRTI resistance substitutions through 96 weeks
- No patients in the DOVATO arm had confirmed virologic withdrawal. Therefore, no patients were evaluated for treatment-emergent resistance
Of the patients in the TAF-containing regimens arm, none had treatment-emergent resistance.
TANGO: 48-Week Resistance Data
A High Barrier to Resistance Through 48 Weeks1
- No patients in the DOVATO arm had confirmed virologic withdrawal (HIV-1 RNA >50 copies/mL followed by a second consecutive HIV-1 RNA assessment >200 copies/mL). Therefore, no patients were evaluated for treatment-emergent resistance¶
One patient on DOVATO, who was withdrawn for protocol deviation (non-compliance with study treatment) and had a last on-treatment viral load of >400 copies/mL, was tested and no INSTI- or NRTI-emergent resistance was detected.2
TANGO: 96-Week Lipids Data
Change from Baseline at 96 Weeks in Serum Lipids2,3
Prespecified secondary endpoint
Based on TANGO trial data. Subjects on lipid-modifying agents at baseline were excluded (DOVATO: 13%; TCR: 15%). Lipid last observation carried forward data were used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values.
HDL=high-density lipoprotein; LDL=low-density lipoprotein; TCR=TAF-containing regimen.
TANGO: 48-Week Lipids Data
Change From Baseline at 48 Weeks in Serum Lipids1,2
Prespecified secondary endpoint
Based on TANGO trial data. Prespecified secondary endpoint. Subjects on lipid-modifying agents at baseline were excluded (DOVATO, n=94; TAF-containing regimens, n=108). Lipid last observation carried forward data were used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values.
- van Wyk J, Ajana F, Bisshop F, et al. Efficacy and safety of switching to dolutegravir/lamivudine fixed-dose 2-drug regimen vs continuing a tenofovir alafenamide-based 3- or 4-drug regimen for maintenance of virologic suppression in adults living with human immunodeficiency virus type 1: phase 3, randomized, noninferiority TANGO study. Clin Infect Dis. 2020;ciz1243. doi:10.1093/cid/ciz1243.
- Data on file, ViiV Healthcare.
- van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen (TBR) in maintaining virologic suppression through 96 weeks (TANGO study). Presented at: HIV Glasgow 2020; October 5-8, 2020; Virtual. Slides O441.