Abstract
In 2 double-blinded Phase 3 trials, 1733 antiretroviral-naive participants were randomized to tenofovir alafenamide (TAF), a tenofovir prodrug versus tenofovir disoproxil fumarate (TDF), each coformulated with elvitegravir/cobicistat/emtricitabine (E/C/F). At 96 weeks, 86.6% in the TAF arm and 85.2% in the TDF arm had HIV-1 RNA <50 c/mL [difference 1.5%; (95% CI: -1.8% to 4.8%)]. With TAF, there are smaller declines in bone mineral density and more favorable changes in proteinuria, albuminuria, and tubular proteinuria, and no cases of proximal tubulopathy compared with 2 for TDF. These longer-term data support E/C/F/TAF as a safe, well-tolerated, and durable regimen for initial HIV-1 treatment.
Publication types
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Clinical Trial, Phase III
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Comparative Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Adenine / adverse effects
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Adenine / analogs & derivatives*
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Adenine / therapeutic use
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Alanine
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Albuminuria / pathology
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Anti-HIV Agents / adverse effects
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Anti-HIV Agents / therapeutic use*
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Bone Density / drug effects
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CD4 Lymphocyte Count
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Cobicistat / adverse effects
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Cobicistat / therapeutic use*
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Double-Blind Method
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Drug Combinations
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Emtricitabine / adverse effects
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Emtricitabine / therapeutic use*
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Female
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HIV Infections / drug therapy*
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HIV-1 / drug effects
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Humans
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Male
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Proteinuria / pathology
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Quinolones / adverse effects
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Quinolones / therapeutic use*
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RNA, Viral / blood
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Tenofovir / adverse effects
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Tenofovir / therapeutic use*
Substances
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Anti-HIV Agents
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Drug Combinations
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Quinolones
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RNA, Viral
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elvitegravir
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Tenofovir
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tenofovir alafenamide
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Emtricitabine
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Adenine
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Cobicistat
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Alanine