FIRM PRESENTS DATA ON INVESTIGATIONAL AGENT IN TREATMENT-NAIVE HIV PATIENTS

Tibotec Pharmaceuticals presented the first results of the phase IIb dose-finding study of TMC278 at a recent conference. Based on the study findings, a 75-mg dose has been selected for Phase III development in treatment-naive patients.

TMC278 is a next-generation investigational non-nucleoside reverse transcriptase inhibitor. It is being studied in treatment-naive HIV patients. The safety and efficacy of TMC278 in combination with other antiretroviral agents has not been established.

TMC278-C204 is a randomized, partially blinded, controlled Phase IIb dose-finding study in 368 treatment-naive, adult HIV-1 patients. In this trial, three once-daily doses of TMC278 -- 25 mg (N=93), 75 mg (N=95) or 150 mg (N=91) -- and efavirenz 600 mg (N=89) are studied in combination with Combivir or Truvada. Thirty-three percent of the study population is female. The results presented are from the 48-week primary endpoint analysis of the study, which is ongoing to 96 weeks. At 48 weeks, 81 percent (25 mg), 80 percent (75 mg) and 77percent (150 mg) of patients receiving TMC278 in combination with other antiretroviral agents had reached the primary endpoint of a confirmed plasma viral load <50 copies/mL; 81 percent of patients in the efavirenz arm also reached the primary endpoint.