Abstract
We report week 96 results from a phase 3 trial of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (EVG/COBI/FTC/TDF, n = 348) vs efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, n = 352). At week 48, EVG/COBI/FTC/TDF was noninferior to EFV/FTC/TDF (88% vs 84%, difference +3.6%, 95% confidence interval: -1.6% to 8.8%). Virologic success (HIV-1 RNA <50 copies/mL) was maintained at week 96 (84% vs 82%, difference +2.7%, 95% CI: -2.9% to 8.3%). Discontinuation due to adverse events was low (5% vs 7%). Median changes in serum creatinine (mg/dL) at week 96 were similar to week 48. These results support the durable efficacy and long-term safety of EVG/COBI/FTC/TDF.
Publication types
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Clinical Trial, Phase III
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Randomized Controlled Trial
MeSH terms
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Adenine / administration & dosage
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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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Adult
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Anti-HIV Agents* / adverse effects
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Anti-HIV Agents* / therapeutic use
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Carbamates* / administration & dosage
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Carbamates* / adverse effects
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Carbamates* / therapeutic use
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Creatinine / blood
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Deoxycytidine / administration & dosage
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Deoxycytidine / adverse effects
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Deoxycytidine / analogs & derivatives*
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Deoxycytidine / therapeutic use
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Double-Blind Method
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Drug Combinations
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Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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Female
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HIV Infections / drug therapy*
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HIV Infections / virology
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HIV-1 / drug effects
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HIV-1 / physiology
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Humans
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Male
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Organophosphonates* / administration & dosage
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Organophosphonates* / adverse effects
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Organophosphonates* / therapeutic use
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Oxazines* / adverse effects
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Oxazines* / therapeutic use
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Quinolones* / administration & dosage
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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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Thiazoles* / administration & dosage
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Thiazoles* / adverse effects
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Thiazoles* / therapeutic use
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Treatment Outcome
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Young Adult
Substances
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Anti-HIV Agents
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Carbamates
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Drug Combinations
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Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
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Organophosphonates
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Oxazines
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Quinolones
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RNA, Viral
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Thiazoles
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Deoxycytidine
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Creatinine
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Adenine