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New 48-Week Efficacy and Safety Data Presented for INTELENCE(TM) (etravirine) as Part of HIV Combination Therapy
Date:2/7/2008

acebo (604 patients), each given in addition to a BR. For all patients, the BR included darunavir/ritonavir, plus at least two investigator-selected antiretroviral drugs (N(t)RTIs with or without enfuvirtide). The study remained double-blinded through 48-weeks.

48-Week Efficacy Findings

-- In DUET-1, 60 percent of patients in the INTELENCE arm had a confirmed

undetectable viral load at 48 weeks compared with 39 percent of those

in the placebo arm [p<0.0001].

-- In DUET-2, 61 percent of patients in the INTELENCE arm had a confirmed

undetectable viral load at 48 weeks compared with 41 percent of those

in the placebo arm [p<0.0001].

-- In DUET-1, the mean increase in CD4+ cell count from baseline was

103 cells/mm3 in the INTELENCE arm compared with 74 cells/mm3 in the

placebo arm [p=0.0025].

-- In DUET-2, the mean increase in CD4+ cell count from baseline was

94 cells/mm3 in the INTELENCE arm compared with 72 cells/mm3 in the

placebo arm [p=0.0160].

48-Week Safety Findings

In DUET-1, the most commonly reported adverse events among patients in the INTELENCE arm vs. placebo arm were rash of any type (22 percent vs. 11 percent), diarrhea (14 percent vs. 24 percent), and nausea (15 percent vs. 15 percent).

In DUET-2, the most commonly reported adverse events among patients in the INTELENCE arm vs. placebo arm were diarrhea (22.0 percent vs. 22.6 percent), rash of any type (16.6 percent vs. 11.1 percent) and nausea (14.6 percent vs. 10.8 percent).

Important Safety Information

INTELENCE(TM) 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
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SOURCE Tibotec Therapeutics
Copyright©2008 PR Newswire.
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