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Simeprevir for hepatitis C – first line


Infectious Disease and Immunisation

September 2012

Simeprevir is intended to be used in combination with peginterferon and ribavirin as first line therapy for the treatment of hepatitis C, viral genotype 1. If licensed it would provide an additional treatment option for this patient group. Simeprevir 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. As such, the enzyme is essential for the biogenesis of the components necessary for HCV replication, and inhibition prevents viral replication.
Recent estimates suggest that there are 173,000 chronically infected HCV patients in England and Wales, of whom around 28,833 are diagnosed. Approximately 80% of people who are infected go on to develop chronic HCV which may result in an inflammatory liver disease with the progressive development of hepatic fibrosis and cirrhosis.
HCV genotype 1 infection is treated with triple combination therapy for a duration influenced by pre-treatment factors (including cirrhosis or response to therapy. Current treatment options include ribavirin and peginterferon in combination with telaprevir or boceprevir. Simeprevir is currently in phase III trials comparing its effect on sustained virologic response against treatment with placebo, both in combination with ribavirin and peginterferon. The trials are expected to complete in 2013.

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