TIBOTEC PRESENTS DATA FROM NNRTI STUDY

Tibotec Pharmaceuticals presented 48-week efficacy and safety data on TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI), at the Internationals AIDS conference in Toronto.

The data presented were the final 48-week analysis of a Phase IIb dose-finding, randomized, partially-blinded study in HIV-1 infected adult patients with substantial treatment experience, documented evidence of NNRTI resistance and three or more PI mutations. A total of 199 patients were randomized to TMC125 (400 mg or 800 mg) plus background regimen or best available control regimen. Of control group patients, 98 percent had discontinued treatment by 48 weeks, compared with 38 percent of TMC125 patients.

The comparison of adverse events and serious adverse events between the TMC125 arms and the control group is confounded because by week 48, 98 percent of patients in the control group had discontinued, mostly for poor virologic response. Overall, 27 percent of TMC125 patients and 18 percent of control patients reported at least one serious adverse event. Four of these events were classified as possibly related to TMC125.