For treatment-naïve and virologically suppressed adults with HIV-1. See Full Indication.

VIROLOGICALLY SUPPRESSED
CLINICAL TRIAL

VIROLOGICALLY SUPPRESSED
CLINICAL TRIAL

TANGO CLINICAL TRIAL

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.

TRIAL DESIGN

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.

Inclusion Criteria:

  • 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)

Secondary Endpoint:

  • 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.

EFFICACY

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

CI=confidence interval

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.

RESISTANCE

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

LIPIDS

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.

References:

  1. 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.
  2. Data on file, ViiV Healthcare.
  3. 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.

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