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July 20, 2011

Elvitegravir Noninferior to Raltegravir

Elvitegravir Noninferior to Raltegravir

In one of the late breaker presentations on the last day of the 6th International AIDS Society Conference in Rome, Jean-Michel Molina, from Hospital Saint Louis, Paris, presented the 44 week data from the first phase 3 randomized controlled trial comparing once daily Elvitegravir (EVG) with twice-daily Raltegravir (RAL) .

Currently Raltegravir is the only approved agent in the integrase inhibitor class. Elvitegravir offers the convenience of once daily dosing. In this study, treatment experienced adults with HIV-1 RNA at least 1000 copies/ml were randomized to EVG 150mg qd (85mg qd when given with atazanavir/ritonavir) or RAL 400mg bid, in addition to a boosted protease inhibitor and a second agent (NRTI, ETR, MVC, T-20) chosen by the investigator, based on resistance testing. The endpoint of the study was virologic suppression <50 copies/mL through week 48 by TLOVR. This was a non-inferiority study with lower limit 95% CI at -10%. Of the subjects approximately 26% had viral loads>100,000 and 44% had CD4 counts <200 cells/mm3. There was significant baseline resistance with approximately 2/3 of participants with NRTI or NNRTI resistance mutations and one-third with primary PI resistance mutations. 724 subjects were randomized to EVG or RAL.

At week 48 EVG was found to be non-inferior to RAL. Discontinuations due to adverse effects were similar in both groups however diarrhea was noted more frequently in the EVG group (12% vs. 7%, p=0.023) and transaminase elevations were more common with RAL. There were no differences in the proportions with virologic failure. Of those subjects experiencing virologic failure, integrase resistance mutations were noted in 27% of those on EVG and 21% on RAL.

This study demonstrating non-inferiority between the agents, as well as similar safety profiles provides optimism for the phase 3 treatment naïve studies in progress that combine EVG as a component of the Quad pill.

Reference: Molina J-M. Elvitegravir once-daily is noninferior to raltegravir twice-daily in treatment experienced patients: 48 week results from a phase 3 multicenter, randomized, double blind study [Oral Abstract].Presented July 20, 2011, at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy. Abstract WELBB05.

Source: Source: Reporting for PRN news from Rome, Italy: Anita Radix, MD