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

Summary Background Elvitegravir is a once daily inhibitor of HIV-1 integrase boosted by ritonavir. We aimed to compare the efficacy and safety of elvitegravir with raltegravir, another HIV-1 integrase inhibitor, in patients in whom previous antiretroviral treatment failed. Methods We conducted a ran...

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Veröffentlicht in:The Lancet infectious diseases 2012, Vol.12 (1), p.27-35
Hauptverfasser: Molina, Jean-Michel, Dr, LaMarca, Anthony, MD, Andrade-Villanueva, Jaime, MSc, Clotet, Bonaventura, MD, Clumeck, Nathan, MD, Liu, Ya-Pei, PhD, Zhong, Lijie, PhD, Margot, Nicolas, MA, Cheng, Andrew K, MD, Chuck, Steven L, MD
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Sprache:eng
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Zusammenfassung:Summary Background Elvitegravir is a once daily inhibitor of HIV-1 integrase boosted by ritonavir. We aimed to compare the efficacy and safety of elvitegravir with raltegravir, another HIV-1 integrase inhibitor, in patients in whom previous antiretroviral treatment failed. Methods We conducted a randomised, double-blind, double-dummy, phase 3 study at 234 sites in 13 countries. Eligible patients had plasma HIV RNA of 1000 copies per mL or greater, any CD4 cell count, and resistance to or 6 months' experience with at least two classes of antiretroviral drugs. They received an open-label background regimen of a fully active, ritonavir-boosted protease inhibitor and a second agent. We randomly allocated patients (1:1) by computer with a block size of four to receive either elvitegravir 150 mg once daily (n=361; 85 mg dose if given with atazanavir, or lopinavir with ritonavir) or raltegravir 400 mg twice daily (n=363). Placebo tablets were given to mask the difference in daily dosing. The primary endpoint was achievement and maintenance of virological response (HIV RNA
ISSN:1473-3099
1474-4457
DOI:10.1016/S1473-3099(11)70249-3