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
- Van Wyk, Jean
- Ajana, Faïzo
- Bisshop, Fiona
- De Wit, Stéphane
- Osiyemi, Olayemi
- Portilla Sogorb, Joaquín
- Routy, Jean-Pierre
- Wyen, Christoph
- Ait-Khaled, Mounir
- Nascimento, Maria Claudia
- Pappa, Keith
- Wang, Ruolan
- Wright, Jonathan
- Tenorio, Allan A.R.
- Wynne, Brian
- Aboud, Michael
- Gartland, Martin
- Smith, Kimberly K.Y.
DOIAbstract
Background: The 2-drug regimen dolutegravir (DTG) + lamivudine (3TC) is indicated for treatment-naive adults with human immunodeficiency virus type 1 (HIV-1). We present efficacy and safety of switching to DTG/3TC in virologically suppressed individuals. Methods: TANGO is an open-label, multicenter, phase 3 study that randomized adults (1:1, stratified by baseline third agent class) with HIV-1 RNA <50 copies/mL to switch to once-daily fixed-dose DTG/3TC or remain on a tenofovir alafenamide (TAF)-based regimen. The primary end point was proportion of participants with HIV-1 RNA ≥50 copies/mL at week 48 (US Food and Drug Administration Snapshot algorithm) in the intention-to-treat-exposed population (4% noninferiority margin). Results: 743 ad...
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