3rd IAS Conference on HIV Pathogenesis and Treatment
July 24 - 27, 2005, Rio de Janerio, Brazil
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Salvage Study of Experimental HIV Protease Inhibitor TMC 114 from Tibotec Yields Outstanding Results TMC 114 is an experimental protease inhibitor (PI) from Tibotec, a subsidiary of Johnson & Johnson. This new PI has shown unusually high potency, including against resistant HIV strains. At the 3rd IAS conference in Rio de Janeiro last week, Dr. Christine Katlama reported 24-week results of the Power 1 study, a multi-center, international, randomized, controlled Phase II trial that employs ritonavir-boosted TM 114 (TMC114/r) as salvage therapy. The study group consists of 318 patients who have experienced virologic failure and who exhibit at least one major PI mutation. These individuals were randomized to one of four doses of the TMC 114/r or to a PI chosen by the investigator. At baseline, each of the 5 groups had similar characteristics: prior treatment with four PIs, three major PI mutations, mean CD4+ T cell count 179 cells/microliter, and a mean viral load of 4.5 log10 copies/mL. Dr.
Katlama provided results from the 255 patients randomized to TMC
114/r. In Table 1 below, the group reported on received TMC/r 600/100mg,
which is the dose chosen for use in the forthcoming Phase
III trials.
The authors of the study conclude that, when used in combination with optimized background drugs, “TMC/r is a potent protease inhibitor.” The unusually high increase in the mean CD4 T cell count and the high percentage of heavily-treated participants experiencing a viral load < 50 copies/mL in the TMC 114 group suggest the drug has remarkable promise as an anti-HIV agent. 08/01/05 Reference |
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