ADVANCE HCV
Research type
Research Study
Full title
A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment – ADVANCE HCV Study
IRAS ID
225727
Contact name
John F Dillon
Contact email
Sponsor organisation
University of Dundee
Eudract number
2017-001039-38
Clinicaltrials.gov Identifier
European Clinical Trials Database (EudraCT) number, 2017-001039-38
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
An estimated 50,000 Scots are infected with Hepatitis C (HCV), a blood borne virus that can cause serious liver damage and death. HCV is transmitted through needle sharing often infecting a person who injects drugs (PWID) early in their habit.
Most infected individuals are unaware they are infected, often showing no symptoms over a long period of time. Up to 25% clear the infection spontaneously, whilst the rest become chronically infected and may develop serious liver disease, including cirrhosis and hepatocellular carcinoma.
Modelling shows that if we treat enough PWID who are the main source of new infections, we may ultimately eradicate HCV from this population.
The focus of this study will be to show whether new oral treatments are successful in a PWID population where illicit drug taking and poor adherence may reduce treatment effectiveness. We will recruit 135 PWID from needle exchange centres and randomly assign them to one of three groups: daily, directly observed therapy; fortnightly dispensing of drugs; fortnightly dispensing of drugs with a psychological interview to help them stick to their medication regime. Individuals infected with the genotype 1 strain of HCV will be treated with licensed medication. Individuals infected with genotype 3 HCV will be treated with an unlicensed combination of drugs, currently licensed individually for treating genotype 1 infection. Patients will be treated for up to 12 weeks. At least 12 weeks post treatment their blood will be tested to see if it is free of virus. We will compare the numbers of patients who are successfully treated in each of the groups. We will also collect information on how well patients stick to their medication regime and will determine what drugs the patients are taking to see whether they interact with the HCV medication.REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0089
Date of REC Opinion
4 Aug 2017
REC opinion
Further Information Favourable Opinion