The 2-drug regimen (2DR) of DTG/3TC reduces the number of antiretroviral agents taken by individuals treated for HIV-1 infection, when compared to traditional 3DRs. DTG/3TC is non-inferior to DTG+TDF/FTC in HIV-1 infected ART-naïve adults (GEMINI) through Week 144 and in ART-experienced, virologically suppressed participants switching from a TAF-based 3/4DR (TANGO) through Week 96. Here we present a key Week 96 secondary endpoint from the TANGO study: Snapshot virologic success by baseline regimen third agent class, disease and demographic characteristics.
TANGO is a randomized, open-label, multicenter, non-inferiority Phase III study evaluating the efficacy and safety of switching to DTG/3TC once daily versus remaining on a current TAF-based regimen in. HIV-1 infected adults, with HIV-1 RNA<50c/mL for >6 months, on a TAF-based regimen for at least 3 months and without prior virologic failure or historical NRTI or INSTI major resistance mutations, were eligible to participate. Randomization was stratified by baseline 3[sup]rd[/sup] agent class: PI, NNRTI, INSTI. The primary endpoint was the proportion of participants with plasma HIV-1 RNA?50c/mL at Week 48 (FDA Snapshot algorithm, Intention To Treat-Exposed [ITT-E] population) with secondary analyses at Week 96.
741 randomized/exposed participants (DTG/3TC: 369; TBR: 372) were included. Snapshot success rates across subgroups were generally consistent with the overall TANGO Week 96 study results and were similar between arms (Figure). Zero participants on DTG/3TC and 3 participants (<1%) on TBR met confirmed virologic withdrawal criteria with no resistance mutations observed at failure.
Switching to DTG/3TC FDC was non-inferior to continuing a TAF-based 3DR in maintaining virologic suppression in HIV-1 infected ART-experienced adults through Week 96. Efficacy by subgroups was consistent with overall Week 96 study results, demonstrating that switching from TAF-based regimens to DTG/3TC is effective at maintaining virologic suppression regardless of baseline regimen, patient or disease characteristics.
