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

Autor:	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
Předmět:	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 VIRAL load ANTIRETROVIRAL agents RANDOMIZED controlled trials TREATMENT effectiveness LAMIVUDINE TENOFOVIR DESCRIPTIVE statistics ADULTS
Zdroj:	Clinical Infectious Diseases; 10/15/2020, Vol. 71 Issue 8, p1920-1929, 10p
Abstrakt:	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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
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