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SHTAC is critically appraising the company’s submission to NICE on sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C

Published: 5 September 2017
Liver
Chronic hepatitis C infection causes liver damage.

SHTAC is assessing the company’s evidence submission to the National Institute for Health and Care Excellence (NICE) on the clinical and cost-effectiveness of sofosbuvir–velpatasvir–voxilaprevir for treating chronic hepatitis C, as part of NICE’s Single Technology Appraisal process.

The hepatitis C virus (HCV) is spread by exposure to infected blood.  The virus infects the cells of the liver and people infected with HCV will often not have any symptoms.  About 15 to 20% of infected people clear the infection naturally within 6 months but the remaining 80 to 85% develop chronic hepatitis C.  Many people with chronic hepatitis C will be unware of their infection because the symptoms are usually mild and non-specific.  Chronic hepatitis C infection causes liver damage which is categorised as mild, moderate or severe.  In severe damage scarring has spread throughout the liver (cirrhosis).  If left untreated, about 20% of people with chronic hepatitis C will develop cirrhosis and some may develop liver cancer.  In severe cases liver transplantation may be required.

The number of people infected with HCV is difficult to determine because many people do not have symptoms.  An active HCV infection can be detected by a blood test. There are six major genotypes and several subtypes of the hepatitis C virus.  Estimates from 2012 suggest that in England approximately 160,000 people have chronic hepatitis C, and that the majority (around 90%) are infected with genotype 1 or 3.

The aim of treatment for hepatitis C is to cure the infection, prevent progression of liver disease and stop the onward transmission of the virus.  The hepatitis C virus genotype influences treatment decisions and treatment response.

Sofosbuvir–velpatasvir–voxilaprevir (brand name: Vosevi®, Gilead Sciences) is a fixed-dose combination tablet containing 3 anti-HCV drugs. Sofosbuvir is a nucleotide analogue that inhibits the non-structural 5B polymerase viral protein which is essential for HCV replication; velpatasvir inhibits NS5A, a protein necessary for viral replication and assembly; and voxilaprevir is a second generation NS3/4A protease inhibitor that blocks a process essential for HCV replication. Sofosbuvir–velpatasvir–voxilaprevir is taken orally for the treatment of HCV genotypes 1 to 6.

NICE is expected to issue guidance to the health service in England on sofosbuvir–velpatasvir–voxilaprevir in May 2018.

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

 

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