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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

  • Hepatic Impairment: INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients.

Adverse Reactions

  • The most common adverse events (>10%) of any intensity that occurred at a higher rate than placebo at 24-weeks were rash (16.9% vs. 9.3%) and nausea (13.9% vs. 11.1%).
  • The most common treatment-emergent adverse reactions (Grade 2-4) that occurred in patients receiving an INTELENCE-containing regimen vs. placebo at 24-weeks were rash (9.0% vs. 3.1%), diarrhea (5.2% vs. 9.6%), nausea (4.7% vs. 3.5%), fatigue (3.3% vs. 4.0%), abdominal pain (3.0% vs. 2.5%), peripheral neuropathy (2.8% vs. 1.8%), hypertension (2.8% vs. 2.2%), headache (2.7% vs. 4.1%), and vomiting (2.3% vs. 2.0%).

Drug Interactions

  • INTELENCE should not be co-administered with the following ARVs: tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without ritonavir, and other NNRTIs.
  • INTELENCE should not be co-administered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/ritonavir) or products containing St. John's wort (Hypericum perforatum).
  • INTELENCE and lopinavir/ritonavir should be co-administered with caution.
  • Co-administration of INTELENCE with other agents such as substrates, inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19 may alter the therapeutic effect or adverse events profile of INTELENCE or the co-administered drug(s). This is not a complete list of potential drug interactions.

Please see full Product Information about INTELENCE for more details. A copy of full Pr
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SOURCE Tibotec Therapeutics
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