WELBB05 - Oral Abstract Session
Elvitegravir once-daily is non inferior to raltegravir twice-daily in treatment experienced patients: 48 week results from a phase 3 multicenter, randomized, double blind study
Presented by Jean-Michel Molina (France).
J.-M. Molina1, A. LaMarca2, J. Andrade Villanueva3, B. Clotet4, N. Clumeck5, Y.-P. Liu6, L. Zhong6, A. Cheng6, J. Szwarcberg6, S.L. Chuck6, for the Study 145 Group
1Hopital Saint Louis, Paris, France, 2Therafirst Medical Center, Fort Lauderdale, United States, 3Hospital Civil de Guadalajara, CUCS, U de G, Guadalajara, Mexico, 4Hospital Universitario Germans Trias i Pujol, Barcelona, Spain, 5C.H.U. St Pierre, Brussels, Belgium, 6Gilead Sciences, Foster City, United States
Background: Elvitegravir is an investigational once-daily integrase inhibitor with a long half life, and robust PK with trough levels of over 10-fold in excess of IC95.
Methods: Adults with plasma HIV-1 RNA ≥1,000 copies/mL, and either resistance or six months experience to > 2 classes of antiretroviral drugs were randomized to receive blinded elvitegravir (EVG) 150 mg QD (85 mg if with atazanavir/lopinavir) or raltegravir (RAL) 400mg BID, in addition to a background regimen (BR) of a fully active ritonavir-boosted protease inhibitor and a second agent (investigator choice). The primary endpoint was the proportion of subjects achieving and maintaining HIV RNA < 50 copies/mL through Week 48 by TLOVR algorithm, with a non-inferiority threshold set at -10% (EVG-RAL).
Results: 702 patients were included in the ITT analysis, mean age was 45 years; 82% were male; 45% had CD4 cell counts ≤200; 26% had HIV RNA >100,000 copies/mL; and 63% had baseline resistance to two or more ARV classes (primary PI 33%, NRTI 72%, and NNRTI 61%). The most common BR combination was Darunavir , Ritonavir and Tenofovir DF (24%).
|Key 48 Week Results||Elvitegravir||Raltegravir||Elvitegravir vs. Raltegravir|
|HIV RNA < 50 copies/mL(TLOVR)
Responder, n (%)||207/351 (59%)||203/351 (58%)||95% CI, -6.0% to 8.2%, * p= 0.001 for non inferiority|
|Increase in CD4 cells/mm3, mean||138||147|| |
|Development of Integrase Resistance||16/62 (26%)||15/76 (20%)|| |
|Discontinuations due to Adverse Events, n (%)||9/354 (3%)||15/358 (4%)|| |
Adverse events (AE) and laboratory abnormalities were similar.
Conclusion: This study demonstrated that once daily EVG was non-inferior to twice daily RAL in treatment-experienced HIV-1 infected subjects.
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