Skip Navigation LinksHome > August 1, 2013 - Volume 63 - Issue 4 > A Randomized Phase 3 Study Comparing Once-Daily Elvitegravir...
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

Collapse Box


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


Article Tools


Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.