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

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.

[1]  Bonaventura Clotet,et al.  Efficacy and safety of once daily elvitegravir versus twice daily raltegravir in treatment-experienced patients with HIV-1 receiving a ritonavir-boosted protease inhibitor: randomised, double-blind, phase 3, non-inferiority study. , 2012, The Lancet. Infectious diseases.

[2]  M. Huque,et al.  A Meta-analysis to Assess the FDA DAVP’s TLOVR Algorithm in HIV Submissions , 2011 .

[3]  A. Zolopa,et al.  Activity of elvitegravir, a once-daily integrase inhibitor, against resistant HIV Type 1: results of a phase 2, randomized, controlled, dose-ranging clinical trial. , 2010, The Journal of infectious diseases.

[4]  B. Clotet,et al.  Long-term efficacy and safety of Raltegravir combined with optimized background therapy in treatment-experienced patients with drug-resistant HIV infection: week 96 results of the BENCHMRK 1 and 2 Phase III trials. , 2010, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[5]  S. West,et al.  Dose–Response of Ritonavir on Hepatic CYP3A Activity and Elvitegravir Oral Exposure , 2009, Clinical pharmacology and therapeutics.

[6]  M. Matsuoka,et al.  Broad Antiretroviral Activity and Resistance Profile of the Novel Human Immunodeficiency Virus Integrase Inhibitor Elvitegravir (JTK-303/GS-9137) , 2007, Journal of Virology.

[7]  Brian P. Kearney,et al.  Antiviral Activity, Pharmacokinetics, and Dose Response of the HIV-1 Integrase Inhibitor GS-9137 (JTK-303) in Treatment-Naive and Treatment-Experienced Patients , 2006, Journal of acquired immune deficiency syndromes.