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

ents discontinued treatment for any reason vs. 73 in the placebo arm.

Most of the rashes seen with TMC125 were mild to moderate in severity, occurred within the first few weeks of treatment and resolved with continued TMC125 treatment. Grade 3 or 4 rash occurred in 1 percent of patients in the TMC125 arm and no patients in the placebo arm.

DUET-1 and -2 Study Design

The DUET studies are double-blind, placebo-controlled, international Phase 3 trials designed to assess the efficacy and safety of TMC125 in treatment- experienced adult HIV-1 patients with documented evidence of NNRTI and PI resistance. Participants were randomized to receive TMC125 200 mg twice daily or placebo, each given in addition to a BR.

In both studies, patient randomization was stratified for enfuvirtide use in the BR (no use, re-use, or first time use), previous darunavir use (used or not), and screening plasma viral load (<30,000 or >=30,000 copies per mL).

Patients with HIV-1 who were eligible for the DUET trials had a viral load of greater than 5,000 copies/mL, were on a stable antiretroviral therapy regimen, and had evidence of at least one NNRTI-resistance-associated mutation, either at screening or from historical resistance tests as well as evidence of three or more primary PI mutations at screening.

TMC125 Expanded Access Program

The expanded access program (EAP) for TMC125 is now open in a number of European countries, Canada and the United States. TMC125 is available to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received licensed treatment from each of the three major oral classes of anti-HIV drugs (NRTIs, NNRTIs, and PIs), unable to use currently approved NNRTIs due to resistance and/or intolerance and have received at least two PI-based regimens.

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