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news.Janssen Therapeutics has received approval from the US Food and Drug Administration (FDA) for the label update of its Prezista (darunavir)tablets to include 192-week data from the Artemis study in HIV patients.
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Artemis (AntiRetroviral Therapy with TMC114 ExaMined In naive Subjects), an international, randomized, controlled, open-label, non-inferiority, Phase 3 trial compared the efficacy and safety of Prezista/r versus lopinavir/r in treatment-naive HIV-1-infected adult patients.
The 192 week trial demonstrated that 70% of patients in the Prezista/r arm reached an undetectable viral load as compared to 61% of patients in the lopinavir/r arm.
Virologic failure was 12% in the Prezista/r arm and 15% in the lopinavir/r arm.
Prezista was developed by Tibotec Pharmaceuticals and is marketed in the US by Janssen Therapeutics.