Authors' objectives:

This study aims to summarise the currently available evidence on thymalfasin (Zadaxin) for hepatitis C virus.

Authors' recommendations: Thymalfasin (Zadaxin, TA-1, thymosin alpha 1) is in phase III trials for the treatment of hepatitis C virus (HCV) in patients who are non-responders to prior therapy. Thymalfasin is injected subcutaneously twice a week and stimulates the production of white blood cells and enhances antigen presentation. If licensed, thymalfasin would be used in combination with pegylated interferon (peg-IFN). Results from a randomised placebo-controlled trial in combination with interferon in 109 patients with HCV found that after 26 weeks serum alanine transaminase (ALT) was reduced in 37% of patients on combination therapy, 16% of patients on IFN only and 3% on placebo. HCV RNA clearance was achieved in 37% of patients on combination treatment, compared to 19% of patients on IFN monotherapy. Three phase III, multi-centred, double blind, placebo-controlled trials are ongoing: two in combination with peg-IFN over 12 months; and 1 in combination with peg-IFN and ribavirin.

Authors' methods: Overview

Project Status: Completed

Year Published: 2005

URL for published report: http://www.hsric.nihr.ac.uk/search

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: National Horizon Scanning Centre (NHSC)