EVOLUTION OF THE BURDEN OF ACTIVE HEPATITIS C INFECTION IN THE UK
Research type
Research Study
Full title
EVOLUTION OF THE BURDEN OF ACTIVE HEPATITIS C INFECTION IN THE UK FROM SEPTEMBER 2015 TO SEPTEMBER 2016: A REPEATED CROSS-SECTIONAL ANALYSIS
IRAS ID
189012
Contact name
Hosnieh Fathi
Contact email
Sponsor organisation
Bristol-Myers Squibb
Duration of Study in the UK
1 years, 6 months, 17 days
Research summary
A new generation of hepatitis C virus (HCV) therapies is now available in the United Kingdom, with the potential to cure the disease in a greater proportion of treated patients. Due to their cost, the use of these treatments is currently restricted to the more severe patients.
In this context, it seems important to provide information on the population with active HCV infection at time of the early access to the new treatments and to evaluate the evolution of this population one year later. These data could help the public health agencies and commissioners to develop optimal strategies to eliminate HCV.
The main objective of this epidemiological study is to describe the characteristics of HCV patients with active chronic viral infection in September 2015 and the changes observed one year later (September 2016) on the size of this population as well as the distribution of genotypes, liver disease severity and others clinical characteristics in HCV patients with active chronic viral infection.
This non-interventional project will be composed of 2 similar studies repeated one year apart in the same hospitals. The first study will include all patients with chronic active hepatitis C at the time of their last visit before 15-Sep-2015. The second study will include: all the patients included in the 2015 study as well as all additional patients with an active infection at the time of their last visit before 15-Sep-2016.
According to the clinical practice in each hospital, patients’ demographic and clinical characteristics at the time of the last hospital visit will be:
• Extracted from the existing database used in routine care;
• Retrospectively collected by a healthcare professional via a chart review of the hospital medical records.
The obtained database will be anonymized in each hospital and sent to a third party for analysis.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0716
Date of REC Opinion
26 Aug 2015
REC opinion
Favourable Opinion