The data, which were presented at the recent Internationals AIDS Conference, were the final 48 week analysis of a phase IIb dose-finding study in HIV-1 infected adult patients with substantial treatment experience, documented evidence of non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance and three or more protease inhibitor mutations.
A total of 199 patients were randomized to TMC125 (400 mg or 800 mg bid) plus background regimen or best available control regimen. 98% of control group patients had discontinued treatment by 48 weeks, compared with 38% of TMC125 patients.
In patients with NNRTI resistance, the viral load reduction in patients receiving TMC125 400mg or 800mg bid in combination with an optimized background regimen was significantly greater than in the active control at 48 weeks.
“These 48 week results in patients with NNRTI-resistance with limited treatment options are encouraging,” said Dr Cal Cohen, research director, CRI New England and Harvard Vanguard Medical Associates, Boston.