TRIAL DESIGN
- TANGO is an ongoing, Phase 3, randomized, noninferiority trial that randomized adults with HIV-1 RNA <50 copies/mL to switch to DOVATO or remain on a TAF-containing regimen
- Designed to evaluate the efficacy and safety of DOVATO, a 2-drug regimen, compared with a 3- to 4-drug TAF-containing regimen. From Week 148 onward, all patients switched to DOVATO, a once-daily DTG 50-mg/3TC 300-mg tablet
INCLUSION CRITERIA
- Adults living with HIV-1 with virologic suppression (HIV-1 RNA <50 copies/mL) for >6 monthsand taking a stable 3- or 4-drug TAF-containing regimen,* who were HBV negative and demonstrated no prior virologic failure and no evidence of major resistance-associated mutation
PRIMARY ENDPOINT
The proportion of patients with HIV-1 RNA≥50 copies/mL at Week 48 using FDA snapshot analysis (ITT–E) with 4% noninferiority margin.
TANGO BASELINE CHARACTERISTICS
- At baseline in the DOVATO arm (N=369), median age was 40 years, 7% of patients were female, 14% of patients were African American or had African American heritage, 81% were white, 4% were Asian, and 73% had CD4+ T-cell count ≥500 cells/mm3
- At baseline in the TAF-containing arm (N=372), median age was 39 years, 9% of patients were female, 16% of patients were African American or had African American heritage, 78% were white, 4% were Asian, and 80% had CD4+ T-cell count ≥500 cells/mm3
*TAF/FTC + EVG/c, DTG, RAL, RPV, NVP, EFV, bATV, or bDRV.23TC=lamivudine; bATV=boosted atazanavir; bDRV=boosted darunavir; DTG=dolutegravir; EFV=efavirenz; EVG/c=elvitegravir-cobicistat; FTC=emtricitabine; HBV=hepatitis B virus; ITT–E=intent-to-treat–exposed; NVP=nevirapine; RAL=raltegravir; RPV=rilpivirine; TAF=tenofovir alafenamide.
