Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial
| Autor: | Osiyemi O, De Wit S, Ajana F, Bisshop F, Portilla J, Routy JP, Wyen C, Ait-Khaled M, Leone P, Pappa KA, Wang R, Wright J, George N, Wynne B, Aboud M, van Wyk J, Smith KY |
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| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | CLINICAL INFECTIOUS DISEASES r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante instname |
| ISSN: | 1058-4838 |
| Popis: | BACKGROUND: Switching to dolutegravir/lamivudine (DTG/3TC) was non-inferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at Week 48 of the TANGO study. Here we present Week 144 outcomes (efficacy, safety, weight, and biomarkers). METHODS: TANGO is a randomized (1:1, stratified by baseline third agent class), open-label, non-inferiority phase 3 study. Virologically suppressed (>6 months) adults with HIV-1 switched to once-daily DTG/3TC or continued TAF-based regimens. RESULTS: 741 participants received study treatment (DTG/3TC, n=369; TAF-based regimen, n=372). At Week 144, proportion of participants with HIV-1 RNA =50 copies/mL (primary endpoint, Snapshot, intention-to-treat-exposed population) after switching to DTG/3TC was 0.3% (1/369) vs 1.3% (5/372) of those continuing TAF-based regimens, demonstrating non-inferiority (adjusted treatment difference, -1.1; 95% CI, -2.4, 0.2), and favored DTG/3TC in the per-protocol analysis (adjusted treatment difference, -1.1; 95% CI, -2.3, -0.0; P=0.044). Few participants met confirmed virologic withdrawal criteria (DTG/3TC, n=0; TAF-based regimen, n=3), with no resistance observed. Drug-related adverse events were more frequent with DTG/3TC (15%; 4% led to discontinuation) than TAF-based regimens (5%; 1% led to discontinuation) through Week 144 and were comparable post-Week 48 (4%; 1% led to discontinuation in both groups). Change from baseline in lipids generally favored DTG/3TC; no clinical impact on renal function and comparable changes in inflammatory and bone biomarkers across groups were observed. CONCLUSIONS: Switching to DTG/3TC demonstrated non-inferior and durable efficacy vs continuing TAF-based regimens in treatment-experienced adults with HIV-1, with good safety and tolerability, and no resistance through 144 weeks. |
| Databáze: | OpenAIRE |
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