Phase 3 Randomized, Controlled Trial of Switching to Fixed-dose Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) from Boosted Protease Inhibitor-based Regimens in Virologically Suppressed Adults: Week 48 Results

• Published in: Open forum infectious diseases 2017-10, Vol.4 (suppl_1), p.S735-S735
• Main Authors: Daar, Eric, DeJesus, Edwin, Ruane, Peter, Crofoot, Gordon, Oguchi, Godson, Creticos, Catherine, Rockstroh, Jurgen K, Molina, Jean-Michel, Koenig, Ellen, Liu, Ya-Pei, Andreatta, Kristen, Graham, Hiba, Cheng, Andrew, Martin, Hal, Quirk, Erin
• Format: Article
• Language: English
• Subjects: Abstracts
• ISSN: 2328-8957; 2328-8957
• DOI: 10.1093/ofid/ofx180.003

Abstract Background Boosted protease inhibitor regimens (bPIs) are effective and often used in HIV-infected individuals with difficulties with adherence, but they can have drug–drug interactions and GI adverse effects. Bictegravir (B), a novel, potent integrase strand transfer inhibitor with a high barrier to resistance and low potential for drug–drug interactions, was coformulated with the recommended nucleoside reverse transcriptase inhibitor backbone emtricitabine (FTC)/tenofovir alafenamide (F/TAF) and demonstrated high efficacy and tolerability in randomized studies in treatment-naïve adults. This randomized Phase 3 study assesses efficacy and safety of switching to B/F/TAF from a multi-tablet regimen containing a bPI. Methods HIV-infected adults suppressed on regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their current bPI regimen or switch to open-label coformulated B/F/TAF (50/200/25 mg) once daily. Primary endpoint was proportion with HIV-1 RNA ≥50 copies/mL (c/mL) at W48 (FDA snapshot). Noninferiority was assessed through 95.002% confidence intervals (CI) using a margin of 4%. Secondary endpoints included proportion with HIV-1 RNA