Abstract
: This 96-week, double-blind, active-controlled, phase 3 study, randomized subjects to elvitegravir once daily or raltegravir twice daily with a fully active, ritonavir-boosted protease inhibitor plus a third agent. The proportion of subjects randomized to elvitegravir that achieved and maintained HIV-1 RNA < 50 copies/mL through week 96 was 47.6% (167/351) compared with 45.0% (158/351) for raltegravir with a treatment difference of 2.6% (95% confidence interval: 4.6% to 9.9%). Both regimens were well tolerated, with comparable rates of adverse events and laboratory abnormalities through week 96. Once-daily elvitegravir was noninferior to twice-daily raltegravir, showed durable long-term efficacy, and was well tolerated in HIV+ treatment-experienced patients.
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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Double-Blind Method
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Drug Resistance, Viral
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Drug Therapy, Combination
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HIV Infections / blood
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HIV Infections / drug therapy*
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HIV Integrase Inhibitors / adverse effects
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HIV Integrase Inhibitors / therapeutic use*
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HIV Protease Inhibitors / therapeutic use
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HIV-1*
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Humans
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Longitudinal Studies
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Pyrrolidinones / adverse effects
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Pyrrolidinones / therapeutic use*
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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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Raltegravir Potassium
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Ritonavir / therapeutic use
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Viral Load
Substances
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HIV Integrase Inhibitors
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HIV Protease Inhibitors
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Pyrrolidinones
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Quinolones
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RNA, Viral
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Raltegravir Potassium
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elvitegravir
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Ritonavir