Hepatitis C and antiviral treatment in inherited bleeding 2019
Research type
Research Study
Full title
Follow-up of the natural history of hepatitis C and the effect of antiviral treatment in patients with inherited bleeding disorders - an international multicentre study
IRAS ID
260247
Contact name
Michael Makris
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 11 months, 29 days
Research summary
Patients with inherited bleeding disorders don’t have normal clotting factors and so are prone to episodes of excessive bleeding. This bleeding is treated by infusion to replace the patient’s missing clotting factor with a manufactured clotting factor product. In the past these products were not adequately purified and some were contaminated with viruses such as Hepatitis C. As a result, some patients treated in the 1970s and 1980s were infected with Hepatitis C virus (HCV). Because most of these patients were infected at the time of their first infusion, the start date of their HCV infection can be fairly easily estimated. Also, the development of the HCV infection and their response to treatment for it is well documented in their medical notes because they undergo regular haematological, chemical, and viral tests when they attend haemophilia centres as part of their routine care. These patients therefore provide a unique opportunity to study the natural history of HCV infection and its associated health effects.
In 2005 an international study looked at the development of end-stage liver disease (ESLD) in HCV infected patients with inherited bleeding disorders from three haemophilia treatment centres in the UK and the Netherlands. The analysis was repeated in 2012-2014.
The present study invloves the same centres and will add another 5-7 years of follow-up to that study. We aim to assess the occurrence of ESLD during the untreated phase of the natural history of HCV in patients with inherited bleeding disorders. Our second aim is to assess the effect of antiviral treatment on HCV eradication, to identify any factors which affect response to antiviral treatment and to use the longer follow-up period to assess the occurrence of ESLD after antiviral treatment has been completed.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/0953
Date of REC Opinion
19 Jun 2019
REC opinion
Favourable Opinion