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

e viral load (less than 50 copies/mL), compared with those in the placebo arm (39 percent; n=119) [p=0.005]. Similarly, in DUET-2, significantly more patients (62 percent; n=183) in the TMC125 arm achieved a confirmed undetectable viral load compared with those in the placebo arm (44 percent; n=129) [p=0.0003].

"The NNRTI class has been one of the cornerstones of antiretroviral therapy for more than a decade. However, NNRTI resistance limits the use of this class in treatment-experienced patients," said Tony Mills, MD, HIV specialist in private practice, Los Angeles, and assistant professor of clinical medicine, UCLA. "The results that we saw in DUET-1 and -2 in patients with documented NNRTI resistance are very exciting and suggest that in the future, we may have the ability to sequence NNRTIs in HIV treatment."

24-Week Safety Findings

In DUET-1, the most commonly reported adverse events (>=10%), regardless of causality, among patients in the TMC125 arm vs. placebo arm were rash (20 percent vs. 10 percent), nausea (14 percent vs. 12 percent), diarrhea (12 percent vs. 20 percent), headache (10 percent vs. 13 percent), nervous system disorders including headache, somnolence, dizziness, and memory impairment (15 percent vs. 20 percent), and psychiatric disorders including insomnia, anxiety, depression and nightmare (10 percent vs. 14 percent). In the TMC125 arm, 42 patients discontinued treatment for any reason vs. 56 patients in the placebo arm.

In DUET-2, the most commonly reported adverse events (>=10%), regardless of causality, among patients receiving TMC125 vs. placebo were rash (14 percent vs. 9 percent), diarrhea (18 percent vs. 20 percent), nausea (14 percent vs. 10 percent), injection site reaction (13 percent vs. 15 percent), headache (9 percent vs. 11 percent), fatigue (9 percent vs. 10 percent), nervous system disorders (15 percent vs. 17 percent) and psychiatric disorders (16 percent vs. 17 percent). In the TMC125 arm, 51 pati
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