TMC435 is a protease inhibitor jointly developed by Medivir (STO:MVIRB) and Tibotec to treat hepatitis C virus infections (HCV). TMC435 is currently being developed in three phase 2b clinical trials (C205, C206 and C215) in G1 treatment-naïve and in G1 patients that failed previous IFN-based treatment.
• C205 is a global phase 2b study initiated in May 2009 in approximately 400 genotype-1 treatment-naïve patients. It is a once daily treatment of TMC435 in doses of 75 mg and 150 mg given in addition to standard of care treatment, consisting of ribavirin and pegIFNalpha-2A.
• C206 is a global phase 2b study initiated in September 2009 in approximately 455 genotype-1 treatment-experienced patients. It is a once daily treatment of TMC435 in doses of 100 mg and 150 mg given in addition to standard of care treatment.
• C215 is a phase 2b study in Japan initiated in June 2009 in approximately 90 genotype-1 treatment-naïve patients. It is a once daily treatment of TMC435 in doses of 50 mg and 100 mg given in addition to standard of care treatment.
During the International Liver Congress™ four posters on TMC435 were presented. The abstract titles are:
1. Combination of TMC435 with two novel NS5B inhibitors increases anti HCV activity and results in a higher genetic barrier in vitro
2. Pharmacokinetic-Pharmacodynamic (PK-PD) Analysis of TMC435 in Treatment-naive Hepatitis C (HCV)-infected patients in the OPERA-1 STUDY
3. Evaluation of Metabolic Interactions for TMC435 via Cytochrome P450 (CYP) Enzymes in Healthy Volunteers
4. Mathematical analysis of clinical data suggests that HCV genotype 1 has a high cellular infection rate that is reduced by Pegylated-Interferon alfa-2a/Ribavirin‹
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