HCV Community Study Version 1
Research type
Research Study
Full title
Evaluation Of A Community Based Service For Hepatitis C Virus Infection
IRAS ID
128641
Contact name
Sumita Verma
Contact email
Sponsor organisation
Brighton and Sussex University Hospital
Research summary
Research Summary
Hepatitis C virus (HCV) infection is a major health burden in England. It causes liver inflammation and if not medically treated liver scarring (cirrhosis), an irreversible condition associated with serious complications (internal bleeding and liver cancer). About 90% of individuals with HCV infection in England have history of substance misuse including injecting drug use. Substance misusers regularly engage with Substance Misuse Services (SMSs). At the SMS they are routinely offered finger prick testing known as dry blood spot testing (DBST) to detect blood borne viruses (BBVs)(HCV, hepatitis B virus (HBV) and the HIV virus] and are also offered HBV vaccination. Those with a positive HCV test are referred to local hospitals though unfortunately most do not attend their appointment. Therefore to increase uptake of HCV treatment, SMSs both in this and other countries have also begun to offer HCV treatment.
We are currently providing a nurse lead standard of care HCV service at the SMS in Brighton to include DBST for BBVs, HBV vaccination and HCV treatment. All SMS attendees will be eligible to participate in this service. The aim of this research is to evaluate this service by .
1.Collection of data as regards demographics, drug and alcohol use, acceptance of DBST, HBV vaccination and HCV treatment including treatment outcomes
2.Conduct of qualitative interviews with SMS attendees and two focus groups with staff members to assess their views about this serviceIndividuals will be offered the HCV service irrespective of whether they consent to participate in the research.
Summary of Results
Background: Achieving hepatitis C virus (HCV) elimination will require linking people who use drugs into care. We report final results from the ITTREAT study where individuals were treated with the new oral HCV drugs direct acting antivirals (DAAs)-.
Project ITTREAT is an eight year study that ran from 2013 and 2021. It was based at a large addiction centre in southeast England. Individuals were tested for HCV and also underwent a scan to look for liver scarring. If found to be HCV positive they received treatment in the addiction centre. The entire service was provided at the addiction centre. Our main outcome was to assess HCV cure rates. We assessed cure rates depending on whether individuals were recruited in first (Period 1) vs. last four (Period 2) years of the study. Period 2 included the COVID pandemic.
Results: On the whole we recruited 765 individuals with an average age of just over 40 years. Most (78%) were men. Overall just over two thirds (65%) had a positive HCV test, of whom 84% had evidence of active virus. About 20% had advanced liver scarring (cirrhosis). Comparing those recruited in period 2 vs. period 1, there was a significantly higher prevalence of injecting drug use 90% vs. 72 %; homelessness, 67% vs. 50% ; psychiatric diagnosis, 84% vs. 50%; drug overdose history 71% vs. 31% (p<0.001), receiving opioid substitution treatment 75% vs. 52% and having other medical problems (44% vs 25%. Of the 405 with active virus infection we treated 272 with an additional 45 being treated at other sites. Overall cure rates were very good at 86%, being similar in Period 1 and Period 2. Cure rates were higher if receiving ribavirin (95% vs. 83%, p=0.015), being on opioid substitution treatment and having at least 80% adherence to treatment. HCV reinfection rates remained lowOf those receiving HCV treatment, 15% died, mortality being mostly drug-related.
Conclusion: People who use drugs have become increasingly more complex over the last eight years Despite increasing complexity of people who use drugs high HCV cure rates can still be achieved in community based- treatment programmes. Use of ribavirin, opioid substitution treatment and adherence are important to achieve cure.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
13/EM/0275
Date of REC Opinion
22 Jul 2013
REC opinion
Further Information Favourable Opinion