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TMC125 Showed Significant Virologic Response at Week 24 in,Treatment-Experienced HIV Patients With NNRTI Resistance in Phase 3,Trials

Data Published in The Lancet on TMC125, an Investigational NNRTI from Tibotec

YARDLEY, Pa., July 05, 2007 /PRNewswire/ -- Data from two ongoing Phase 3 studies (DUET-1 and DUET-2) showed significantly more HIV-1 adult patients with documented non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance reached an undetectable viral load (defined as achieving confirmed undetectable level < 50 HIV-1 RNA copies/mL) with TMC125 (etravirine), Tibotec's investigational next-generation NNRTI, plus background regimen compared to placebo plus background regimen at week 24. These findings were published in the July 7, 2007, issue of The Lancet.

TMC125 is the first NNRTI to show significant antiviral activity in patients with documented NNRTI resistance. Tibotec, Inc. plans to file these findings with the Food and Drug Administration as part of a New Drug Application.

DUET-1 and DUET-2 examined the use of TMC125 in combination with other anti-retroviral medications in treatment-experienced adult HIV-1 patients with documented resistance to NNRTIs and PIs. These data will be presented at the 4th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2007), in Sydney, Australia, on July 25, 2007.

A total of 612 patients were randomized and treated in DUET-1 - 304 in the TMC125 plus background regimen (BR) group and 308 in the placebo plus BR group. In DUET-2, a total of 591 patients were randomized and treated - 295 in the TMC125 plus BR group and 296 in the placebo plus BR group. For all patients, the BR included 600 mg darunavir, co-administered with 100 mg ritonavir, twice-daily, plus investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs) and optional use of enfuvirtide.

Results from the DUET-1 study showed that significantly more patients (56 percent; n=170) in the TMC125 arm achieved a confirmed undetectabl
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