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Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
Date:12/21/2007

ypic testing

should guide the use of PREZISTA/r.

-- The use of other active agents with PREZISTA/r is associated with a

greater likelihood of treatment response.

-- The risks and benefits of PREZISTA/r have not been established in

treatment-naive adult patients or pediatric patients.

ARTEMIS

The sNDA submission includes the 48-week efficacy and safety results of ARTEMIS (AntiRetroviral Therapy with TMC114 Examined In naive Subjects), a Phase 3, randomized, controlled, open-label study that compared the efficacy and safety of PREZISTA/r with the PI lopinavir/r in treatment-naive HIV-1-infected adult patients. Patients were randomized to receive a PREZISTA/r dose of 800 mg/100 mg once daily (an investigational dose) or, based on approved dosing in each country, either lopinavir/r 800 mg/200 mg once daily or 400 mg/100 mg twice daily, plus an optimized background regimen (OBR) of tenofovir and emtricitabine once daily. Data from this study were presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago on September 18, 2007.

TITAN

The sNDA submission also includes data from TITAN (TMC114/r In Treatment-experienced pAtients Naive to lopinavir/ritonavir), a 96-week, Phase 3, randomized, controlled, open-label study, comparing the efficacy and safety of a PREZISTA/r dose of 600 mg/100 mg twice daily with lopinavir/r 400 mg/100 mg twice daily, each with OBR, in treatment-experienced HIV-1-infected adult patients who were lopinavir/r-naive. Forty-eight week data from this study were published in the July 7, 2007, issue of The Lancet and presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention in Sydney, Australia, on July 24, 2007.

Important Safety Information

PREZISTA does not cure HIV infection or AIDS, and does not prevent passing HIV to others.

PREZISTA is contraindicated in patients with
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SOURCE Tibotec, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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