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Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)
Date:2/5/2009

lished in pediatric patients or in treatment-naive adult patients.

DUET-1 AND DUET-2

The traditional approval filing includes the 48-week efficacy and safety results of DUET-1 and DUET-2, two Phase 3 randomized, placebo-controlled studies that examined the use of INTELENCE in combination with other antiretroviral agents in adult treatment-experienced HIV-1 patients with documented resistance to NNRTIs and protease inhibitors. Participants in the DUET studies were randomized to receive INTELENCE 200 mg twice daily or placebo, each given in addition to a background regimen. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide). Forty-eight-week data from this study were presented at the 15th Conference on Retroviruses and Opportunistic Infections in Boston on February 7, 2008.

Important Safety Information

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

  • Severe and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema multiforme, have occurred (<0.1 percent) in patients taking INTELENCE. Treatment with INTELENCE should be discontinued and appropriate therapy initiated if severe rash develops.
  • In general, in clinical trials, rash was mild to moderate, occurred primarily in the second week of therapy, and was infrequent after Week 4. Rash generally resolved within 1-2 weeks on continued therapy. Discontinuation rate due to rash was two percent.
  • Redistribution and/or accumulation of body fat have been observed in patients receiving antiretroviral (ARV) therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.
  • Immune reconstit
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SOURCE Tibotec, Inc.
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