Atazanavir + ritonavir vs. Lopinavir-ritonavir CASTLE Study

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Presentation transcript:

Atazanavir + ritonavir vs. Lopinavir-ritonavir CASTLE Study

Atazanavir + Ritonavir vs Atazanavir + Ritonavir vs. Lopinavir-ritonavir in Treatment-Naïve CASTLE: Study Design Study Design: CASTLE Background: Randomized, open label trial to evaluate the comparative efficacy of once-daily atazanavir + ritonavir versus twice-daily lopinavir- ritonavir, each with fixed dose tenofovir DF- emtricitabine, in treatment-naïve adults with HIV infection Inclusion Criteria (n = 883) - Age ≥18 - Antiretroviral treatment-naïve - HIV RNA >5000 copies/mL - No CD4 count restrictions Treatment Arms - Atazanavir 300 mg QD+ Ritonavir 100 mg QD + Tenofovir DF-emtricitabine QD - Lopinavir-ritonavir 400-100mg BID + Tenofovir DF-emtricitabine QD Atazanavir + Ritonavir + Tenofovir DF-Emtricitabine (n = 440) Lopinavir-ritonavir + Tenofovir DF-Emtricitabine (n = 443) Source: Molina JM, et al. Lancet. 2008;372:646-55.

Atazanavir + Ritonavir vs Atazanavir + Ritonavir vs. Lopinavir-ritonavir in Treatment-Naïve CASTLE: Results Week 48: Virologic Response, by Baseline HIV RNA ( ITT: CVR, NC= F*) *ITT= intent to treat; CVR = confirmed virologic response; NC = non completer = failure Source: Molina JM, et al. Lancet. 2008;372:646-55.

Atazanavir + Ritonavir vs Atazanavir + Ritonavir vs. Lopinavir-ritonavir in Treatment-Naïve CASTLE: Results Week 48: Virologic Response, by Baseline CD4 Cell Count *ITT= intent to treat; CVR = confirmed virologic response; NC = non completer = failure Source: Molina JM, et al. Lancet. 2008;372:646-55.

Atazanavir + Ritonavir vs Atazanavir + Ritonavir vs. Lopinavir-ritonavir in Treatment-Naïve CASTLE: Results Week 48: Change in Fasting Lipids from Baseline *P < 0.0001 Source: Molina JM, et al. Lancet. 2008;372:646-55.

Atazanavir + Ritonavir vs Atazanavir + Ritonavir vs. Lopinavir-ritonavir in Treatment-Naïve CASTLE: Conclusions Interpretation: “In treatment-naive patients, atazanavir/ritonavir once-daily demonstrated similar antiviral efficacy to lopinavir/ritonavir twice-daily, with less gastrointestinal toxicity but with a higher rate of hyperbilirubinaemia.” Source: Molina JM, et al. Lancet. 2008;372:646-55.