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

• Published in: Journal of acquired immune deficiency syndromes (1999) Vol. 63; no. 4; pp. 494 - 497
• Main Authors: Elion, Richard, Molina, Jean-Michel, Ramón Arribas López, José, Cooper, David, Maggiolo, Franco, Wilkins, Edmund, Conway, Brian, Liu, Ya-Pei, Margot, Nicolas, Rhee, Martin, Chuck, Steven L, Szwarcberg, Javier
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins, Inc 01-08-2013; Lippincott Williams & Wilkins; Lippincott Williams & Wilkins Ovid Technologies
• Subjects: Antiretroviral drugs; Biological and medical sciences; Comparative analysis; Double-Blind Method; Drug Resistance, Viral; Drug Therapy, Combination; Fundamental and applied biological sciences. Psychology; HIV; HIV Infections - blood; HIV Infections - drug therapy; HIV Integrase Inhibitors - adverse effects; HIV Integrase Inhibitors - therapeutic use; HIV Protease Inhibitors - therapeutic use; HIV-1; Human immunodeficiency virus; Human viral diseases; Humans; Indexing in process; Infectious diseases; Longitudinal Studies; Medical sciences; Microbiology; Miscellaneous; Protease inhibitors; Pyrrolidinones - adverse effects; Pyrrolidinones - therapeutic use; Quinolones - adverse effects; Quinolones - therapeutic use; Raltegravir Potassium; Ribonucleic acid; Ritonavir - therapeutic use; RNA; RNA, Viral - blood; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Viral Load; Virology; HIV-1; Immunopathology; HIV-1 virus; Retroviridae; Elvitegravir; AIDS; Immune deficiency; Lentivirus; efficacy; Infection; Virus; Treatment; Efficiency; Viral disease; safety; Human immunodeficiency virus; Raltegravir
• ISSN: 1525-4135; 1944-7884
• DOI: 10.1097/QAI.0b013e318298469c

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 interval4.6% 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.