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- Title
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
- Authors
Wyk, Jean van; Ajana, Faïza; Bisshop, Fiona; Wit, Stéphane De; Osiyemi, Olayemi; Sogorb, Joaquín Portilla; Routy, Jean-Pierre; Wyen, Christoph; Ait-Khaled, Mounir; Nascimento, Maria Claudia; Pappa, Keith A; Wang, Ruolan; Wright, Jonathan; Tenorio, Allan R; Wynne, Brian; Aboud, Michael; Gartland, Martin J; Smith, Kimberly Y
- Abstract
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 adults were enrolled; 741 received ≥1 dose of study drug (DTG/3TC, N = 369; TAF-based regimen, N = 372). At week 48, proportion of participants with HIV-1 RNA ≥50 copies/mL receiving DTG/3TC was 0.3% (1/369) vs 0.5% (2/372) with a TAF-based regimen (adjusted treatment difference [95% confidence interval], −0.3 [−1.2 to.7]), meeting noninferiority criteria. No participants receiving DTG/3TC and 1 receiving a TAF-based regimen met confirmed virologic withdrawal criteria, with no emergent resistance at failure. Drug-related grade ≥2 adverse events and withdrawals due to adverse events occurred in 17 (4.6%) and 13 (3.5%) participants with DTG/3TC and 3 (0.8%) and 2 (0.5%) with a TAF-based regimen, respectively. Conclusions DTG/3TC was noninferior in maintaining virologic suppression vs a TAF-based regimen at week 48, with no virologic failure or emergent resistance reported with DTG/3TC, supporting it as a simplification strategy for virologically suppressed people with HIV-1. Clinical Trials Registration NCT03446573.
- Subjects
COMBINATION drug therapy; DOSE-effect relationship in pharmacology; GENERIC drug substitution; DRUG side effects; HIV; HIV infections; HIV-positive persons; MEDICAL cooperation; PATIENT safety; RESEARCH; RNA; UNITED States. Food &; Drug Administration; VIRAL load; ANTIRETROVIRAL agents; RANDOMIZED controlled trials; TREATMENT effectiveness; LAMIVUDINE; TENOFOVIR; DESCRIPTIVE statistics; ADULTS
- Publication
Clinical Infectious Diseases, 2020, Vol 71, Issue 8, p1920
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciz1243