A new NS3/4A inhibitor



TMC435 is a selective small molecule inhibitor of the viral NS3/4A protease. It is currently being evaluated in HCV genotype-1 infected patients.



Cinical trials



OPERA-1 (TMC435-C201; NCT00561353). A phase 2a proof-of-concept trial in treatment-naïve and treatment-experienced patients with chronic genotype 1 HCV infection is fully enrolled. In this trial the effectiveness, safety, tolerability and pharmacokinetics of repeated doses of TMC435, with or without peginterferon alpha-2a and ribavirin, have been studied.



TMC435-C202 (NCT00812331). A phase IIa proof-of-concept trial in treatment-naïve patients with chronic genotype 2, 3, 4, 5 and 6 HCV infection is fully enrolled. This is an exploratory study in which viral kinetics, safety and pharmacokinetic / pharmacodynamic relationship will be studied..



For physicians who would like additional information regarding this phase 2a clinical trial, please visit TMC435350-TiDP16-C202 : "A Study to Assess the Activity of TMC435 on Hepatitis C Virus in Patients Who Have Never Received Treatment for Their Hepatitis C Infection", or send us an e mail at: tibbe-info@its.jnj.com.



The phase IIb trials (PILLAR, NCT00882908, and ASPIRE, NCT00980330) in both treatment naïve and experienced patient populations with chronic genotype 1 HCV infection are fully enrolled. Based on these trials the optimal dose and duration of TMC435 in the naïve and experienced patient populations will be established.



For further information of our phase 2b program: please visit www.clinicaltrials.gov.