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96-Week Safety and Efficacy Findings Presented for INTELENCE(TM) (etravirine) As Part of HIV Combination Therapy
Date:7/20/2009

BRIDGEWATER, N.J., July 20 /PRNewswire/ -- Ninety-six week pooled results from two Phase 3 studies (DUET-1 and DUET-2) showed that significantly more treatment-experienced HIV-1-infected adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance had an undetectable viral load (<50 HIV-1 RNA copies/mL) while taking INTELENCE(TM) (etravirine) tablets plus background regimen (BR) compared with placebo plus BR. These findings were presented today at the 5(th) International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009) in Cape Town, South Africa.

In the pooled analysis of the DUET studies at 96 weeks, 57 percent of patients in the INTELENCE arm had an undetectable viral load (<50 copies/mL) compared to 36 percent of patients in the placebo arm (p<0.0001).

"These data are important because they add to the body of knowledge on INTELENCE, an important option for treatment-experienced patients with NNRTI and PI resistance," said DUET clinical investigator Tony Mills, MD, HIV specialist in private practice, Los Angeles, and Assistant Professor of Clinical Medicine, UCLA.

When it received accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2008, INTELENCE was the first NNRTI to be introduced in nearly ten years. Since then, INTELENCE has been approved in nearly 50 countries. In January 2009, an application was submitted to the FDA for traditional approval, which included 48-week data from DUET-1 and DUET-2. The FDA will need to determine if these data are sufficient to support traditional approval.

When it received accelerated approval by the U.S. Food and Drug Administration (FDA) in January 2008, INTELENCE was the first NNRTI to be introduced in nearly ten years. Since then, INTELENCE has been approved in nearly 50 countries. In Januar
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SOURCE Tibotec Therapeutics
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