FDA Approves Prezista Labeling That Includes 192-Week Data

PREZISTA (darunavir) tablets by Tibotec
PREZISTA (darunavir) tablets by Tibotec
Janssen Therapeutics announced that the FDA has approved a labeling update for Prezista (darunavir tablets) that includes 192-week data from the ARTEMIS study. ARTEMIS (AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects) is an international, randomized, controlled, open-label, non-inferiority, Phase 3 trial that compared the efficacy and safety of Prezista/ritonavir vs. lopinavir/ritonavir in treatment-naive HIV-1-infected adult patients with viral load >5,000copies/mL.

The 192-week analysis showed that 70% of patients in the Prezista/ritonavir arm reached an undetectable viral load (<50copies/mL) vs. 61% of patients in the lopinavir/ritonavir arm.  Virologic failure was 12% in the Prezista/ritonavir arm and 15% in the lopinavir/ritonavir arm. Statistical superiority of Prezista/ritonavir over the lopinavir/ritonavir regimen was demonstrated in both the intent-to-treat and on-protocol analysis.

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