TIBOTEC REPORTS PHASE IIB DATA ON INVESTIGATIONAL HIV COMPOUNDS
Tibotec Pharmaceuticals has reoprted primary 24-week efficacy and safety results from the POWER 2 trial on TMC114, a protease inhibitor (PI), in treatment-experienced patients and the first long-term clinical results of TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI) in HIV-1 patients with NNRTI resistance. Both TMC114 and TMC125 are currently being studied in Phase III trials.
Study results showed that 62 percent of patients achieved a reduction in viral load of 1 log10 or more in the highest TMC114/r dose group, 600mg/100mg BID, compared to 14 oercent in the control group. A total of 278 patients were randomized to receive optimized background regimen plus one of four doses of TMC114/r.
At 24 weeks, the percentage of patients reaching undetectable virus levels was 39 percent in the highest TMC114/r dose group compared with 7 percent in the control arm. This study will continue to 144-weeks.