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

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

Author Information

*Whitman-Walker Health, Washington, DC;

Hospital Saint-Louis, APHP, University of Sorbonne Paris Cité, Paris 7, INSERM U941, France;

Hospital Universitario La Paz, IdiPAZ, Servicio de Medicina Interna, Unidad VIH, Madrid, Spain;

§Kirby Institute, University of New South Wales, Sydney, Australia;

Ospedali Riuniti di Bergamo, Bergamo, Italy;

North Manchester General Hospital, Manchester, United Kingdom;

#Vancouver ID Research & Care Centre, Vancouver, Canada; and

**Gilead Sciences, Inc., Foster City, CA.

Correspondence to: Richard Elion, MD, Whitman-Walker Health, Washington, DC, (e-mail: relion@whitman-walker.org).

Suported by Gilead Sciences, Inc.

Presented at 6th IAS Conference on HIV Pathogenesis, July 17–20, 2011, Rome, Italy.

R. E., has received research grant support from Gilead and consulting fees as an advisory board member for Gilead; J-M. M., has received research grant support from Merck and consulting fees as an advisory board member for Merck, Gilead, BMS, and Janssen; J. R. A. L., has received research grant support from Gilead, BMS, and MSD and consulting fees as an advisory board member for Janssen, Abbott, and Gilead; D. C., has received research grant support from Merck and Gilead and consulting fees as an advisory board member for Merck and Gilead; F. M., has received research grant support from GSK, Gilead, and BMS and consulting fees as an advisory board member for Boeheringer, BMS, Gilead, GSK, Tibotec, and MSD; E. W., has received consulting fees as an advisory board member for ViiV, Gilead, BMS, MSD, Janssen, and Abbott; B. C., has received research grant support from Gilead and consulting fees as an advisory board member for Gilead; Y-P. L., N. M., M. R., S. L. C., and J. S., are employed by Gilead Sciences.

© 2013 by Lippincott Williams & Wilkins