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BACKGROUND The HIV integrase strand transfer inhibitor elvitegravir (EVG) has been co-formulated with the CYP3A4 inhibitor cobicistat (COBI), emtricitabine (FTC), and tenofovir disoproxil fumarate (TDF) into a once-daily, single tablet. We compared EVG/COBI/FTC/TDF with a ritonavir-boosted (RTV) protease inhibitor regimen of atazanavir (ATV)/RTV+FTC/TDF as(More)
This ongoing, randomized, double-blind, active-controlled phase 3 international trial demonstrated the noninferior efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir DF (EVG/COBI/FTC/TDF) compared with atazanavir boosted by ritonavir (ATV/RTV) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) at 48 weeks. Here, we report the week 96(More)
BACKGROUND All recent treatment guidelines recommend integrase strand transfer inhibitors (INSTIs) as components of initial HIV therapy. Bictegravir, a novel, once-daily, unboosted INSTI, showed potent activity in a 10 day monotherapy study and has a high in-vitro resistance barrier. On the basis of these results, we did a phase 2 trial comparing(More)
BACKGROUND Tenofovir alafenamide (TAF) is a novel tenofovir prodrug with improved renal and bone safety compared with TDF-containing regimens. We report the 48 week safety and efficacy of a once-daily single tablet regimen of elvitegravir 150 mg (E), cobicistat 150 mg (C), emtricitabine 200 mg (F), and TAF 10 mg (E/C/F/TAF) in HIV-1-infected patients with(More)
BACKGROUND Elvitegravir (EVG), a HIV integrase inhibitor, is metabolized primarily by CYP3A, and secondarily by UGT1A1/3; Efavirenz (EFV), a HIV non-nucleoside reverse transcriptase inhibitor, is metabolized by Cytochrome P450 (CYP) 2B6 and induces CYP3A and uridine diphosphate glucuronosyltransferase (UGT) with residual effects post discontinuation because(More)
Results: Twenty participants were enrolled (n = 4/group). Mean DAVG11 ranged from 20.92 to 21.61 across BIC doses versus 20.01 for placebo. Significant reductions in plasma HIV-1 RNA from baseline at day 11 were observed for all BIC doses compared with placebo (P , 0.001); mean decreases were 1.45–2.43 log10 copies/mL. Increased BIC exposures correlated(More)
Anton Pozniak, MD,* Jose R. Arribas, MD,† Joseph Gathe, MD,‡ Samir K. Gupta, MD,§ Frank A. Post, MD,k Mark Bloch, MD,¶ Anchalee Avihingsanon, MD,# Gordon Crofoot, MD,** Paul Benson, MD,†† Kenneth Lichtenstein, MD,‡‡ Moti Ramgopal, MD,§§ Ploenchan Chetchotisakd, MD,kk Joseph M. Custodio, PhD,¶¶ Michael E. Abram, PhD,¶¶ Xuelian Wei, PhD,¶¶ Andrew Cheng, MD,(More)
BACKGROUND Integrase strand transfer inhibitors (INSTIs) are recommended components of initial antiretroviral therapy with two nucleoside reverse transcriptase inhibitors. Bictegravir is a novel, potent INSTI with a high in-vitro barrier to resistance and low potential as a perpetrator or victim of clinically relevant drug-drug interactions. We aimed to(More)
BACKGROUND Acid-reducing agents are commonly used co-medications by HIV-1-infected patients receiving antiretroviral treatment. The effects of various representative acid-reducing agents on the pharmacokinetics (PK) of boosted elvitegravir were evaluated by 1-way interaction in 4 studies. METHODS Healthy subjects received ritonavir-boosted elvitegravir(More)