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SHTAC is critically appraising manufacturer’s submission to NICE on simeprevir for adults with chronic hepatitis C

Published: 27 May 2014

SHTAC is assessing the clinical-effectiveness and cost-effectiveness of simeprevir for the treatment of genotype 1 or 4 chronic hepatitis C as part of the National Institute for Health and Care Excellence (NICE) Single Technology Appraisal process.

The hepatitis C virus is spread by exposure to infected blood. The virus causes inflammation of the liver but often people with hepatitis C do not have any symptoms. Some infected people will naturally clear the infection within 6 months but the majority (80-85%) develop chronic hepatitis which can be life-long. The symptoms of chronic hepatitis C are usually mild and non-specific. Consequently many people with chronic hepatitis C will be unaware of their infection. If left untreated about 30% of people with chronic hepatitis C infection will eventually develop liver cirrhosis and some may develop liver cancer. Some patients may require a liver transplant. Estimates for 2012 indicate that around 215,000 people are chronically infected with the hepatitis C virus in the UK.

There are six major genotypes and several subtypes of the hepatitis C virus. In the UK approximately 90% of people with a chronic infection of hepatitis C virus are infected with genotype 1 or genotype 3. Hepatitis C virus genotype influences treatment decisions and treatment response. The aim of treatment is to cure the infection, prevent progression of liver disease and stop the onward transmission of the virus.

Simeprevir is a protease inhibitor that prevents viral replication because it inhibits an enzyme that is essential for hepatitis C virus replication. Simeprevir is taken orally in combination with other drugs that are used for treating hepatitis C.

NICE is expected to issue guidance to the health service in England on simeprevir in January 2015.

For more information on SHTAC's research into infectious diseases please visit our Research page.

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