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New 48-Week Efficacy and Safety Data Presented for INTELENCE(TM) (etravirine) as Part of HIV Combination Therapy

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 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 reconstitution syndrome has been reported in patients treated

with ARV therapy, including INTELENCE

-- 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

-- The most common adverse events (>10 percent) of any intensity that

occurred at a higher rate than placebo at 24-weeks were rash (16.9

percent vs. 9.3 percent) and nausea (13.9 percent vs. 11.1 percent)

-- 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 percent vs. 3.1 percent), diarrhea

(5.2 percent vs. 9.6 percent), nausea (4.7 percent vs. 3.5 percent),

fatigue (3.3 percent vs. 4.0 percent), abdominal pain (3.0 percent vs.

2.5 percent), peripheral neuropathy (2.8 percent vs. 1.8 percent),

hypertension (2.8 percent vs. 2.2 percent), headache (2.7 percent vs.

4.1 percent), and vomiting (2.3 percent vs. 2.0 percent).

Drug Interactions

-- INTELENCE should not be co-administered with the following ARVs:

tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/riton

SOURCE Tibotec Therapeutics
Copyright©2008 PR Newswire.
All rights reserved

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