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FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
Date:10/21/2011

ResultsThe ARTEMIS study compared the efficacy and safety of PREZISTA/r 800/100 mg once daily (n=343) versus lopinavir/r 800/200 mg total daily dose (n=346) in treatment-naive adults with HIV-1. All patients received a fixed-dose combination of tenofovir and emtricitabine once daily. At 192 weeks, PREZISTA/r was shown to be non-inferior to lopinavir/r. This 192 week analysis showed that:

-- 70% of patients in the PREZISTA/r arm reached an undetectable viral load (less than 50 copies/m.) vs. 61% of patients in the lopinavir/r arm.  Virologic failure was 12% in the PREZISTA/r arm and 15% in the lopinavir/r arm. Statistical superiority of PREZISTA/r over the lopinavir/r regimen was demonstrated in both the intent-to-treat (ITT) and on-protocol (OP) analysis.

-- The most common treatment-related adverse reactions (greater or equal to 5 percent) of moderate intensity (greater or equal to grade 2) among patients in the PREZISTA/r arm vs. lopinavir/r arm were: diarrhea (9 percent vs. 16 percent); headache (7 percent vs. 6 percent); abdominal pain (6 percent vs. 6 percent); and rash (6 percent vs. 7 percent).

About the ARTEMIS StudyARTEMIS (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/r versus lopinavir/r in treatment-naive HIV-1-infected adult patients with viral load greater than 5,000 copies/mL.

The main objective of the study was to demonstrate non-inferiority of PREZISTA/r versus lopinavir/r in the proportion of patients achieving virologic response, defined as confirmed HIV RNA less than 50 copies/mL. Non-inferiority of PREZISTA/r vs. lopinavir/r was defined as a maximum allowable difference of 12 percent for virologic response, with a one-sided significance level of alpha equal to 0.025.

Important Safety Information PREZISTA does not cure HIV-1 infection or AIDS, and
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SOURCE Janssen Therapeutics, Division of Janssen Products, LP
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