Saquinavir + RTV versus Lopinavir-RTV in Treatment-Naïve GEMINI Trial

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Presentation transcript:

Saquinavir + RTV versus Lopinavir-RTV in Treatment-Naïve GEMINI Trial

SQV/r (1000/100 mg BID) + TDF-FTC LPV/r (400-100 mg BID) + TDF-FTC Saquinavir + RTV versus Lopinavir-RTV in Treatment Naïve GEMINI: Study Design Study Design: GEMINI Background: Randomized, open-label, non- inferiority, phase III trial comparing the safety and efficacy of saquinavir plus ritonavir with lopinavir- ritonavir, both with tenofovir DF-emtricitabine, in treatment-naïve patients with HIV infection Inclusion Criteria (n = 337) - Age >18 - Antiretroviral-naïve - CD4 count ≤350 cells/mm3 - HIV RNA >10,000 copies/mL Treatment Arms - Saquinavir 1000 mg BID + ritonavir 100 mg BID + TDF-FTC QD - Lopinavir-ritonavir (400-100) BID + TDF-FTC QD SQV/r (1000/100 mg BID) + TDF-FTC (n=167) LPV/r (400-100 mg BID) + TDF-FTC (n=170) Source: Walmsley S, et al. J Acquir Immune Defic Syndr. 2009;50:367-74.

Saquinavir + RTV versus Lopinavir-RTV in Treatment Naïve GEMINI: Results Week 48: Virologic Response (ITT, Missing=Failure) 108/167 108/170 121/167 127/170 Source: Walmsley S, et al. J Acquir Immune Defic Syndr. 2009;50:367-74.

Saquinavir + RTV versus Lopinavir-RTV in Treatment Naïve GEMINI: Results Week 48: Analysis of Lipids Source: Walmsley S, et al. J Acquir Immune Defic Syndr. 2009;50:367-74.

Saquinavir + RTV versus Lopinavir-RTV in Treatment-Naïve GEMINI: Conclusions Conclusions: “In treatment-naive, HIV-1-infected patients, SQV/r treatment was noninferior in virologic suppression at 48 weeks to LPV/r treatment and offered a better triglyceride profile.” Source: Walmsley S, et al. J Acquir Immune Defic Syndr. 2009;50:367-74.