Evaluating Treatment as Prevention Among People Who Inject Drugs in Dundee for HCV (ERAPID HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03356405
Recruitment Status : Active, not recruiting
First Posted : November 29, 2017
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
John Dillon, University of Dundee

Brief Summary:
The aim of this study is to conduct an evaluation of hepatitis C treatments in NHS Tayside in order to empirically test the "treatment as prevention" models. This will be done by analysing the records of patients who have been tested and treated for hepatitis C using NHS Tayside databases. There will be no interventions carried out as part of this study.

Condition or disease
Hepatitis C Viral

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Detailed Description:

Hepatitis C is a blood-borne virus (HCV) that can seriously damage the liver and is spread mainly through blood-to-blood contact with an infected person. The "serious and significant public health risk" posed by HCV was recognised during a member's debate in the Scottish Parliament in 2004. By December 2006, Health Protection Scotland estimated that 50,000 persons in Scotland had been infected with the Hepatitis C virus and that 38,000 were chronic carriers. Currently, the greatest risk of acquiring the virus in the UK is through injecting drug use. In Scotland, it is estimated that over 85% of individuals who have Hepatitis C were infected in this way.

The outcome of HCV infection varies considerably between individuals. Some (up to 25%) are able to clear the infection spontaneously, whilst the remaining 75% become chronically infected. Within the subpopulation of chronically infected patients, some will develop serious liver disease, including cirrhosis and hepatocellular carcinoma, within a few years, whilst in others liver disease will not progress even over a period of more than forty years. Hepatitis C is often referred to as the 'silent epidemic.' Many who are infected are unaware of it, and often show no symptoms over a long period of time. While there is presently no vaccination for Hepatitis C, the recent introduction of protease inhibitor-based directly acting anti-viral treatments (DAA) has begun a new era in treatment of this disease. These new oral treatments are extremely safe, have shorter treatment regimens than previous drugs, and are effective, producing a cure in over 90% of cases providing compliance is adequate.

The advent of more effective DAA therapies raises the possibility of using therapy as prevention, turning the epidemic off at source, by targeting active infected drug users who are the main source of new infections.

The modelling work of the investigators shows that HCV treatment is a critical component to HCV prevention among people who inject drugs and is likely to be cost-effective compared to delaying treatment or treating non-PWID with mild or moderate disease. For example, the investigators show in a number of settings with chronic HCV in PWID below 60% that treating 10-20 per 1000 drug users per year can reduce HCV prevalence by 50-90% over 10-15 years; that for every one PWID treated in the 20% chronic HCV setting 2 new HCV infections are averted. The scale of the benefit is inversely and exponentially related to prevalence of HCV in the population, the lower the prevalence the sooner and bigger the impact.

Current conventional treatment pathways focus on populations drawn from those known to drug problem services and former drug users. Treating people who are the most stable and with a low risk of relapse back into chaotic injecting will reduce future morbidity in the individual patients but may not achieve additional benefit in terms of averting future infections. The recent work of the investigators within Tayside has shown that they are able to test less stable, actively injecting drug users for Hepatitis C and then successfully treat them using both the conventional care pathway and non-conventional care pathways, such as needle exchange clinics (e.g. Eradicate study, completed February 2017; Advance study, aiming to start in October 2017), community pharmacies (SuperDOTC study, ongoing) and prisons. If the models are correct, this intensive treatment programme will effectively eradicate Hepatitis C from Tayside over the next few years. However, the models are not yet empirically tested and they make some assumptions that if violated may lead to over or under-estimation of the intervention effect. For example, the models assume that (a) heterogeneity in injecting risk and uptake of HCV testing and treatment will even out as PWID move and transition between high and low risk periods; and (b) that HCV transmission risk for susceptible PWID is similar for those that have achieved SVR or are untreated.

The intensive treatment approach in Tayside provides an ideal opportunity to empirically test the "treatment as prevention" models. The current study will not involve direct recruitment or treatment of patients. Instead, it will evaluate the portfolio of care pathways currently being used to treat HCV in Tayside and test the hypothetical modelling to determine whether treatment of HCV will work as prevention of future spread of the virus.

Study Type : Observational [Patient Registry]
Actual Enrollment : 2800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Evaluating Treatment as Prevention Among People Who Inject Drugs in Dundee for HCV
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. The number of HCV positive tests recorded in NHS Tayside. [ Time Frame: 6 years ]
    The number of reactive DBST conducted in NHS Tayside.

Secondary Outcome Measures :
  1. The number of patients engaged in treatment and SVR12 during the treatment phase [ Time Frame: 6 years ]
    The numbers of patients who are treated for HCV and the number who achieve an SVR12.

  2. The cost of treatment [ Time Frame: 6 years ]
    The cost of treating HCV infection in PWID will be measured.

  3. Re-infection with HCV following treatment [ Time Frame: 6 years ]
    Annual routine offer of HCV testing

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All individuals in NHS Tayside eligible for HCV testing and treatment according to Scottish Intercollegiate Guidelines Network guidelines.

Inclusion Criteria:

  • All individuals in NHS Tayside eligible for HCV testing and treatment according to Scottish Intercollegiate Guidelines Network guidelines.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03356405

United Kingdom
NHS Tayside
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee

Responsible Party: John Dillon, Professor John Dillon, University of Dundee Identifier: NCT03356405     History of Changes
Other Study ID Numbers: 2016GA08
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hepatitis C
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases