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Hepatitis C (HCV) infection viral genotype 1 – patients who have relapsed following previous interferon-based therapy; in combination with peginterferon alfa-2a and ribavirin.
Simeprevir (TMC-435, TMC435350, R494617) is an orally-active NS3/4A protease inhibitor. NS3 mediates the cleavage and release of four non-structural HCV proteins: NS4A, NS4B, NS5A and NS5B. The NS3/4A enzyme is essential for the biogenesis of the components necessary for HCV replication and inhibition prevents viral replication.
Simeprevir is intended to be used for patients with HCV genotype 1 who have relapsed following treatment with previous interferon-based therapy. Simeprevir is administered orally at 150mg, once daily for 12 weeks in combination with peginterferon alfa-2a (PegINFα-2a) or peginterferon alfa-2b (PegINFα-2b) plus ribavirin (RBV). Simeprevir is also in phase III clinical trials for the treatment of HCV in treatment-naive patients.
HCV is a member of the flaviviridae family of spherical, enveloped, positive-strand RNA viruses. There are six different HCV genotypes; genotype 1 is the most common and the most resistant to treatment1. The virus is acquired primarily through percutaneous exposure to contaminated blood2. Most acute infections with HCV are asymptomatic with only 20% experiencing an overt hepatitis3. Approximately 80% of people who are infected go on to develop chronic HCV2, which may result in an inflammatory liver disease with the progressive development of hepatic fibrosis and cirrhosis3. Chronic HCV is categorised as mild, moderate or severe depending on the extent of liver damage. The progression from infection to cirrhosis is variable in time but on average takes 40 years2. About 30% of those who are infected with HCV develop cirrhosis within 20–30 years4,5. There are a number of factors known to increase the rate of progression such as age, excessive alcohol consumption and HIV co-infection.