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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

ual to 10 percent) among patients in the INTELENCE arm vs. placebo arm, regardless of causality, were rash (21 percent vs. 12 percent), diarrhea (19 percent vs. 24 percent), nausea (15 percent vs. 14 percent), nasopharyngitis (14 percent vs. 12 percent), headache (12 percent vs. 14 percent), cough (11 percent vs. 9 percent) and herpes simplex (10 percent vs. 10 percent).
  • The incidence of nervous system and psychiatric AEs was comparable between the INTELENCE and placebo arms. Nineteen percent of patients in the INTELENCE arm experienced nervous system disorders and 20 percent reported psychiatric disorders, compared to 21 percent of patients in the placebo arm who experienced either AE.
  • Important Safety Information

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

    Warnings & Precautions

    • Severe Skin Reactions: Severe and potentially life-threatening skin reactions, including Stevens-Johnson Syndrome, hypersensitivity reaction, and erythema multiforme, have occurred (<0.1%) 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 2%.
    • Fat Redistribution: 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 reconstitution syndrome has been reported in patients treated with ARV therapy, including INTELENCE.

    Use in Specific Populations


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    SOURCE Tibotec Therapeutics
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