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JAIDS Journal of Acquired Immune Deficiency Syndromes:
doi: 10.1097/QAI.0b013e318298469c
Brief Report: Clinical Science

A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir With Twice-Daily Raltegravir in Treatment-Experienced Subjects With HIV-1 infection: 96-Week Results

Elion, Richard MD*; Molina, Jean-Michel MD; Ramón Arribas López, José MD; Cooper, David MD§; Maggiolo, Franco MD; Wilkins, Edmund MD; Conway, Brian MD#; Liu, Ya-Pei PhD**; Margot, Nicolas MS**; Rhee, Martin MD**; Chuck, Steven L. MD**; Szwarcberg, Javier MD, MPH**; for the Study 145 Team

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Abstract

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.

© 2013 by Lippincott Williams & Wilkins

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