Authors' objectives: Simeprevir (Olysio) is a potent inhibitor of the NS3/4A proteins of the hepatitis C virus (HCV) genotypes 1 and 4. Sofosbuvir (Sovaldi) is a second generation uridine nucleotide analogue that inhibits the HCV NS5B protein. Together, in combination (with or without ribavirin) they are intended for the treatment of chronic hepatitis C (genotype 1 and 4) in treatment naïve and treatment experienced adult patients. This combination is intended for use as substitute therapy (and not restricted to patients who are interferon intolerant and in urgent need of treatment only). Simeprevir is licensed in the EU for the treatment of chronic HCV infection, in combination with other medicinal products. Sofosbuvir is licensed in the EU as Sovaldi for the treatment of chronic HCV infection, in combination with ribavirin with and without peginterferon alfa. The true incidence of HCV infection is difficult to establish as an estimated 86% of infected individuals are unaware of their infection status. Recent estimates suggest that in the UK, around 214,000 individuals are chronically infected with HCV, with an estimated 160,000 in England, equating to approximately 0.4% of the adult population. In 2012, there were 10,873 new diagnoses of HCV infection in England, an increase of more than one-third since 2010. In 2013-14, there were 1,958 hospital admissions in England due to chronic hepatitis C, accounting for 2,182 finished consultant episodes and 3.642 bed days, and in 2013, 189 deaths were registered in England and Wales. The primary aim of treatment is to clear circulating virus from the blood. A sustained virological response (SVR) indicates permanent resolution of infection, with re-infection rarely occurring. Simeprevir and sofosbuvir in combination are currently in three phase III clinical trials comparing their effect on sustained virological response 12 (SVR12). These trials are expected to complete by January 2016.

Project Status: Completed

Year Published: 2015

URL for published report: http://www.hsric.nihr.ac.uk/topics/simeprevir-in-combination-with-sofosbuvir-with-or-without-ribavirin-for-chronic-hepatitis-c/

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Horizon Scanning Centre

Contact Address: The NIHR Horizon Scanning Centre, Department of Public Health, Epidemiology, and Biostatistics, School of Health and Population Sciences, University of Birmingham, 90 Vincent Drive, Edgbaston, Birmingham, B15 2SP. United Kingdom. Tel: +44 121 414 7831, Fax: +44 121 2269

Contact Name: c.packer@bham.ac.uk

Contact Email: c.packer@bham.ac.uk

Copyright: NIHR Horizon Scanning Research&Intelligence Centre (NIHR HSRIC)