Roche's Invirase non-inferior to Kaletra

5 November 2007

Final 48-week results from a head-to-head trial presented today at the 11th European AIDS Conference, held in Madrid, Spain, demonstrated that treatment-naive HIV patients treated with Swiss drug major Roche's protease inhibitor Invirase (saquinavir mesylate), boosted with ritonavir, achieved similar levels of viral suppression and increases in CD4 cells compared to those treated with US health care major Abbott Laboratories' Kaletra (lopinavir/ritonavir). Furthermore, fewer patients treated with Invirase developed elevated triglyceride levels.

Sharon Walmsley, lead investigator on the GEMINI study, noted that "these data are of considerable importance because they confirm that Invirase offers treatment-naive patients an effective treatment to control the virus with significantly smaller increases in triglyceride levels than lopinavir, the most commonly-prescribed PI." The findings show that boosted Invirase 500mg was not inferior to lopinavir/r, with 64.7% and 63.5% of patients treated with Invirase/r and lopinavir/r, respectively, achieving undetectable HIV. A similar number of patients in both groups (approximately 73%) achieved undetectable HIV of less than 400 copies/mL of blood. Furthermore, the rate and extent of increases in CD4 counts were comparable in both groups, with a median increase from baseline of 178 for the Invirase/r-treated patients and 204 for lopinavir/r patients.

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