alexa A randomized phase 3 study comparing once-daily elvitegravir with twice-daily raltegravir in treatment-experienced subjects with HIV-1 infection: 96-week results.


Journal of Antivirals & Antiretrovirals

Author(s): Elion R, Molina JM, Ramn Arribas Lpez J, Cooper D, Maggiolo F,

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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. This article was published in J Acquir Immune Defic Syndr and referenced in Journal of Antivirals & Antiretrovirals

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