For treatment-naïve and virologically suppressed adults with HIV-1. See Full Indication.
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 Adults
Phase 3, randomized, multicenter, noninferiority switch study1,2*
From Week 148 onward, all participants were switched to DOVATO.
Once-daily DTG 50 mg/3TC 300 mg tablet.
Secondary Endpoint:
- Proportion of participants with HIV-1 RNA ≥50 copies/mL and <50 copies/mL by Snapshot algorithm, ITT–E (4% noninferiority margin for ≥50 copies/mL and 8% noninferiority margin for <50 copies/mL) at 96 weeks and 144 weeks.
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
This trial included 39% of participants with unknown genotypic resistance history.
ART=antiretroviral therapy; CDC=Centers for Disease Control and Prevention.
EFFICACY
Durable Virologic Suppression Out Through 144 Weeks
DOVATO maintained noninferior efficacy in the ITT-E analysis at 144 weeks1,3,4
§At Week 96, the number of participants with no virologic data due to COVID-19 (14% for the DOVATO arm and 20% for the TAF-containing regimens arm) was the primary driver in the treatment difference in the secondary endpoint.
CI=confidence interval.
RESISTANCE
A High Barrier to Resistance Through 144 Weeks3
0 cases of virologic failure through 144 weeks in virologically suppressed participants
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- No treatment-emergent resistance was detected. Only participants meeting CVW criteria were evaluated for treatment-emergent resistance
- CVW was defined as HIV-1 RNA ≥50 copies/mL followed by a second consecutive HIV-1 RNA ≥200 copies m/L
- This trial included 39% of participants with unknown genotypic resistance history
Of the participants in the TAF-containing regimens arm, none had treatment-emergent resistance.
LIPIDS
Change From Baseline at 144 Weeks in Serum Lipids2,3
Prespecified secondary endpoint3
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.
Change From Baseline at 144 Weeks in Renal Function
Prespecified secondary endpoint2,3,5#
Adjusted for treatment, baseline third agent class, baseline CD4 T-cell count, age, sex, race, BMI, presence of diabetes, presence of hypertension, and baseline marker value.
Based on estimated geometric means ratio of Week 144 vs baseline. Based on the same model as plasma/serum markers except adjusting for loge-transformed baseline marker.
BMI=body mass index; CKD=chronic kidney disease epidemiology collaboration; eGFR=estimated glomerular filtration rate; HDL=high-density lipoprotein; LDL=low-density lipoprotein; n=number of participants with non-missing data at baseline and Week 144; SE=standard error.
References:
- 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, Ait-Khaled M, Santos J, et al. Metabolic health outcomes at week 144 in the TANGO study, comparing a switch to DTG/3TC versus maintenance of TAF-based regimens. Presented at: 11th IAS Conference on HIV Science; July 18-21, 2021; Virtual. Poster PEB164.
- 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. Slide O441.
- Osiyemi O, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen in maintaining virologic suppression through 144 weeks (TANGO Study). Presented at: IDWeekTM 2021; September 29-October 3, 2021; Virtual. Slide 900.
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