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FDA Approves INTELENCE(TM) (etravirine) for HIV Combination Therapy
Date:1/18/2008

[p<0.0001].

-- Significantly greater mean increase in CD4+ cell count from baseline;

mean increase of 81 vs. 64 cells/mm(3)[p=0.0022]

The results of DUET-1 and DUET-2 were published separately in two articles in the July 7, 2007 issue of The Lancet, and the pooled analysis from the DUET studies was presented at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September 2007.

DUET-1 and -2 Resistance

-- The presence of K103N, which was the most prevalent NNRTI substitution

in DUET-1 and -2 studies at baseline, did not affect the response in

the INTELENCE arm.

-- The presence at baseline of the substitutions V179D, V179F, V179T,

Y181V, or G190S was associated with a decreased virologic response to

INTELENCE.

-- In the DUET-1 and -2 studies, the presence at baseline of three or more

2007 IAS-USA-defined NNRTI substitutions (V90I, A98G, L100I, K101E/P,

K103N, V106A/I/M, V108I, V179D/F, Y181C/I/V, Y188C/H/L, G190A/S, P225H)

resulted in a decreased virologic response to INTELENCE.

-- For patients in the DUET-1 and -2 studies experiencing virologic

failure on an INTELENCE-containing regimen, the substitutions that

occurred most commonly were V179F, V179I, Y181C, and Y181I which

usually emerged in a background of multiple other NNRTI

resistance-associated substitutions. Other NNRTI resistance-associated

substitutions which emerged in patients on INTELENCE treatment in

< 10 percent of the virologic failure isolates included K101E, K103N,

V106I/M, V108I, Y188L, V189I, G190S/C and R356K.

-- Cross-resistance to delavirdine, efavirenz, and/or nevirapine is

expected after virologic failure with an INTELENCE-containing regimen.

DUET-1 and -2 Tolerability

In the DUET-1 and -2 studies, the most common adverse events (> 10 percent) o
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SOURCE Tibotec Therapeutics
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