Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Me...( Nearly 90 percent of patients ach...),Health

Nearly 90 percent of patients achieve undetectable viral load in Phase IIa trial within 28 days of combined treatment with standard of care

SAN FRANCISCO, Nov. 1 /PRNewswire/ -- New clinical data show antiviral activity of TMC435, an investigational protease inhibitor (PI) being developed by Tibotec BVBA for the treatment of chronic hepatitis C virus (HCV) infection. Tibotec will present findings from three TMC435 studies, including a late-breaker poster on the proof-of-principle phase IIa trial, OPERA-1 (TMC435-C201), at the American Association for the Study of Liver Disease's (AASLD) Liver Meeting 2008 in San Francisco.

The current standard of care treatment for HCV infection, pegylated interferon (Peg-IFN) combined with ribavirin (RBV), is effective in 30 to 50 percent of patients infected with chronic genotype 1 HCV infection, the most common type in the United States.(1) The development of new therapies and strategies for treating HCV, particularly the introduction of direct antivirals, may offer patients a new option with shorter treatment duration.(2,3)

TMC435 Phase IIa Study Results

In interim findings from the first 28 days of treatment for the first cohort of fifty (50) treatment naive HCV+, genotype 1, patients (once daily dose of 25 mg or 75 mg TMC435 versus placebo), both doses showed dose-dependent antiviral activity. TMC435 was administered in combination with PegIFNalpha-2a/RBV (triple therapy) for 28 days or as monotherapy for seven days and, thereafter, in combination with PegIFNalpha-2a/RBV (triple therapy) for three weeks. There were neither serious adverse events, nor grade 3 or 4 adverse events, related to TMC435 or any safety-related treatment discontinuations during this 28 day treatment period.

The most common adverse events associated with TMC435 were nausea, diarrhea, and headache. There were no clinically relevant changes in laboratory parameters, ECGs, or vital signs. Steady-state plasma trough
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