Evaluating Treatment as Prevention Among People Who Inject Drugs in Dundee for HCV
Conditions: Hepatitis C Viral
Sponsor: University of Dundee

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Study Protocol 
Evaluating Treatment as Prevention among People Who Inject 
Drugs in Dundee for HCV  (E-raPiD-HCV) 
 
 
 
Study Acronym 
Erapid 
Sponsor 
University of Dundee and NHS Tayside 
Sponsor R&D Number 
2016GA08 
Funder 
Merck Sharp Dohme (MSD) 
Chief Investigator 
Professor John Dillon 
REC Number 
17/ES/0136 
Clinical Trials Unit  
Tayside Clinical Trials Unit (TCTU) 
Version Number and Date 
Version 2 18/03/2020 
NCT number 
NCT03356405 
 

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Contents 
1 
INTRODUCTION ........................................................................................................ 6 
2 
BACKGROUND & RATIONALE ............................................................................... 7 
3 
STUDY OBJECTIVES & OUTCOMES ...................................................................... 7 
4 
STUDY DESIGN ........................................................................................................ 7 
4.1 
INTERVENTION .............................................................................................. 7 
4.2 
STUDY DESCRIPTION ................................................................................... 7 
4.3 
STUDY FLOWCHART ..................................................................................... 7 
4.4 
STUDY MATRIX .............................................................................................. 8 
4.8 
INCIDENTAL FINDINGS ................................................................................. 8 
4.9 
study POPULATION ........................................................................................ 8 
4.10 
NUMBER OF PARTICIPANTS ........................................................................ 8 
4.11 
INCLUSION CRITERIA .................................................................................... 8 
5 
PARTICIPANT SELECTION AND ENROLMENT ..................................................... 8 
5.1 
IDENTIFYING PARTICIPANTS ....................................................................... 8 
6 
DATA COLLECTION & MANAGEMENT .................................................................. 8 
6.1 
Data Collection ................................................................................................. 8 
6.2 
Data Management System .............................................................................. 9 
7 
STATISTICS AND DATA ANALYSIS ....................................................................... 9 
7.1 
SAMPLE SIZE CALCULATION ....................................................................... 9 
7.2 
PROPOSED ANALYSES ................................................................................. 9 
7.3 
TRANSFER OF DATA ..................................................................................... 9 
8 
STUDY MANAGEMENT AND OVERSIGHT ARRANGEMENTS ........................... 10 
8.1 
STUDY MANAGEMENT GROUP .................................................................. 10 
8.2 
STUDY STEERING COMMITTEE ................................................................. 10 
8.3 
INSPECTION OF RECORDS ........................................................................ 10 
9 
GOOD CLINICAL PRACTICE ................................................................................. 10 
9.1 
ETHICAL CONDUCT OF THE STUDY ......................................................... 10 
9.2 
Confidentiality................................................................................................. 10 
9.3 
Data Protection .............................................................................................. 10 
9.4 
Insurance and Indemnity ................................................................................ 11 
10 
ADVERSE EVENTS - NOT RELEVANT TO THIS STUDY..................................... 11 
11 
ANNUAL REPORTING REQUIREMENTS ............................................................. 11 
12 
STUDY CONDUCT RESPONSIBILITIES................................................................ 11 
12.1 
PROTOCOL AMENDMENTS, deviations and breaches ............................... 11 
12.2 
STUDY RECORD RETENTION .................................................................... 11 
12.3 
END OF STUDY ............................................................................................ 11 
13 
REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS ................... 12 
13.1 
AUTHORSHIP POLICY ................................................................................. 12 
13.2 
PUBLICATION ............................................................................................... 12 
13.3 
PEER REVIEW .............................................................................................. 12 
14 
REFERENCES ......................................................................................................... 12 
 
 
 
 
 
 
 
 

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Signatures 
The undersigned confirm that the following protocol has been agreed and approved by the 
Sponsor and that the Chief Investigator agrees to conduct the trial/study/study in compliance 
with this approved protocol and will adhere to the principles of GCP, the Sponsor SOPs, and 
any other applicable regulatory requirements as may be amended from time to time. 
 
John Dillon 
 
 
 
Chief Investigator 
Signature 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
 
CI 
Chief Investigator 
CNORIS 
Clinical Negligence and Other Risks Scheme 
HCV 
Hepatitis C Virus 
GCP 
Good Clinical Practice 
NESI 
Needle exchange surveillance initiative 
NSP 
Needle service programme 
OST 
Opioid substitution therapy 
PWID 
People who inject drugs 
REC 
Research Ethics Committee 
SOP 
Standard Operating Procedures 
SMF 
Study Master File 
SVR12 
Sustained viral response at least 12 weeks 
after end of treatment 
SMG 
Management Group 
TSC 
Trial Steering Committee 
 
 
 

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SUMMARY/SYNOPSIS 
. 
 
Study Title  
Evaluating Treatment as Prevention among People Who Inject Drugs 
in Dundee for HCV  (E-raPiD-HCV) 
 
Study Design 
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.   
Study Population 
This study will monitor the target PWID population (we estimate 
approximately 2,800 individuals) as we intensify the number of treatments 
provided to this population and achieve levels of treatment that will test 
the “treatment as prevention” concept.  
Sample Size 
Approximately 2,800 individuals 
Planned study Period  
6 years 
Primary 
Objectives 
To 
demonstrate 
treatment 
as 
prevention reduces HCV.   
Outcome Measures 
HCV testing in NHS Tayside  
Secondary 
 
Objectives 
Outcome Measures 
To develop the analytic framework 
that can be used to assess the 
impact of treatment as prevention, 
incorporating 
evidence 
from 
multiple sources and taking into 
account uncertainty and bias 
Numbers of patients engaged in 
treatment and SVR12 during the 
treatment phase 
To 
develop 
dynamic 
cost-
effectiveness 
models 
of 
HCV 
treatment among PWID 
Costs of treatment pathways and 
infection rates 
Re-infection with HCV following 
treatment 
Annual  routine offer of HCV testing 
Inclusion Criteria 
All individuals in NHS Tayside eligible for HCV testing and treatment 
according to Scottish Intercollegiate Guidelines Network guidelines. 
Exclusion Criteria 
None 
 
 
 

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1 
INTRODUCTION 
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 (1, 2). 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 (3).  
 
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 
(4). 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 (5). 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 (6).  
 
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. 
 
Our modelling work 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 (7-11).  For example, we 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. Our recent 
work within Tayside has shown that we 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, started in January 2018, ongoing), community 
pharmacies (SuperDOTC study, December 2016 – January 2019. REACH HCV study, started 
February 2020, ongoing) and prisons (12). 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. 
 
Our 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.  

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2 
BACKGROUND & RATIONALE 
We have embarked on a series of studies that will dramatically increase the number of PWID 
with HCV infection who are being treated. This allows us to test empirically modelling data 
predicting treatment as prevention works for HCV infection. We are aiming to treat enough 
people actively injecting drugs who are infected with Hepatitis C in Tayside to reduce the 
prevalence in this population from approximately 29% to less than 10%. This will reduce the 
incidence of new infections from over 5% per annum to less than 1% per annum which we can 
detect with population surveillance techniques. 
 
3 
STUDY OBJECTIVES & OUTCOMES  
 
 
Table 1: Primary Objectives and Outcome Measures 
 
Primary Objective: 
Outcome Measure: 
Timepoint of outcome  
measured 
To 
demonstrate 
treatment 
as 
prevention reduces HCV.   
HCV testing in NHS Tayside  
Annually 
 
Table 2: Secondary Objectives and Outcome Measures 
 
Secondary Objective: 
Outcome Measure: 
Timepoint of outcome  
measured 
To develop the analytic framework 
that can be used to assess the 
impact of treatment as prevention, 
incorporating 
evidence 
from 
multiple sources and taking into 
account uncertainty and bias 
Numbers of patients engaged in 
treatment and SVR12 during the 
treatment phase 
Years 1-3 
To 
develop 
dynamic 
cost-
effectiveness 
models 
of 
HCV 
treatment among PWID 
Costs of treatment pathways and 
infection rates 
Year 5 
Re-infection with HCV following 
treatment 
Annual  routine offer of HCV 
testing 
Following treatment and 
subsequently 
annually 
for each PWID 
 
4 
  STUDY DESIGN 
4.1 
INTERVENTION  
There is no intervention associated with this study. 
4.2 
STUDY DESCRIPTION 
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.  Individuals working on this project will apply for Caldicott Guardian approval. As 
described previously, a number of strategies are being used to intensively identify and treat 
individuals with hepatitis C within Tayside. 
 
4.3 
STUDY FLOWCHART 
There will be no interventions carried out as part of this study. The timepoints for measurements 
are shown in Table 2. 
 

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4.4 
STUDY MATRIX 
There will be no interventions carried out as part of this study. The timepoints for measurements 
are shown in Table 2. 
 
4.8 
INCIDENTAL FINDINGS 
 
4.9 
  STUDY POPULATION 
The entire PWID population in Tayside (we estimate approximately 2,800 individuals)  
 
4.10 NUMBER OF PARTICIPANTS 
Approximately 2,800 individuals 
4.11 INCLUSION CRITERIA 
Data will be included from NHS Tayside NESI and treatment databases so the inclusion criteria 
will be all those eligible for HCV testing and treatment in NHS Tayside. 
 
Scottish Intercollegiate Guidelines Network (SIGN) guidelines recommend that the following 
groups should be offered testing : 
 
• 
patients with an otherwise unexplained persistently elevated alanine aminotransferase 
• 
people with a history of injecting drug use 
• 
people who are human immunodeficiency virus (HIV) positive 
• 
recipients of blood clotting factor concentrates prior to 1987 
• 
recipients of blood and blood components before September 1991 and organ/tissue 
transplants in the UK before 1992 
• 
children whose mother is known to be infected with HCV 
• 
healthcare professionals following percutaneous or mucous membrane exposure to 
blood which is, or is suspected to be, infected with HCV 
• 
people who have received medical or dental treatment in countries where HCV is 
common and infection control may be poor 
• 
people who have had tattoos or body piercing in circumstances where infection control 
procedure is, or is suspected to be, suboptimal 
• 
people who have had a sexual partner or household contact who is HCV infected. 
• 
Anyone who believes themselves to be at risk. 
 
 
5 
PARTICIPANT SELECTION AND ENROLMENT 
 
5.1 
IDENTIFYING PARTICIPANTS 
Individual participants will not be consented into this trial. In accordance with the inclusion 
criteria, participants will be identified and analysed using NHS Tayside databases (following 
Caldicott approval). 
 
 
 
6 
DATA COLLECTION & MANAGEMENT 
6.1 
DATA COLLECTION 
Details of all patients who are undergoing or have completed HCV treatment in Tayside are 
entered into a clinical database as per standard care by specialist HCV nurses and this practice 
will continue as we intensify treatment rates through our clinical trials and NHS treatment 
pathways. Data in this database will form the source for treatment initiation and outcomes. 
Twice a year the number of patients treated and cured since last data extraction will be 
extracted with no patient identifiable information but with data on viral genotype, stage of liver 
disease, pathway of treatment delivery and current drug use status.  

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Data on infection rates from routine HCV testing within NHS Tayside is also collected in the 
virology service in Tayside for government reporting. On a six monthly basis we will extract data 
on known HCV negative patients who have been retested in that time period. The data 
extraction will consist of the date when they were last known to be negative, the date of re-test 
and the result of the test. No patient identifiable data will be used.  
  
Population level data will be collected 6 monthly around the anniversary of the study 
commencement or to coincide with the NESI data collection cycles.  
 
The source data will be accessed by the clinical care team and clinical data which is not patient 
identifiable entered into the study data management system which will be built within Excel and 
held on a University server that is GCP compliant; regularly backed-up, has access controls 
and updates to operating system and security software. Caldicott approvals will be obtained as 
required. 
 
6.2 
DATA MANAGEMENT SYSTEM 
Data management will be conducted in compliance with TASC SOPs on Data Management, 
including TASC SOP33 Data Management to GCP standards and TASC SOP53 Data 
Management Systems in Clinical Research. 
 
 
The data management system (DMS) will be Excel. The data will be used to calculate the 
treatment rate and cure rate for the time period and the rate of new infection. The core data will 
then be destroyed. The anonymized dataset may be shared with colleagues in other UK 
Universities.The database is managed in line with all applicable principles of medical 
confidentiality and UK law on data protection, namely, the Data Protection Act 1998, which 
brought UK law into line with the EU Data Protection Directive. The Data Controller will be the 
University of Dundee and the Data Custodian will be the CI. 
 
 
 
7 
   STATISTICS AND DATA ANALYSIS 
7.1 
SAMPLE SIZE CALCULATION 
All those eligible for HCV testing and treatment in Tayside, currently estimated at 2800. 
7.2 
PROPOSED ANALYSES 
Initially descriptive analysis will be used. In the final analysis statistical and mathematical 
models will develop the analytic framework that can be used to assess impact incorporating 
evidence from multiple sources and taking into account uncertainty and bias from our multiple 
data sources.  We will combine Multiple Parameter Evidence Synthesis and Infectious Disease 
Models in order to measure the primary outcome and objective. We also will establish what 
ongoing surveillance and monitoring arrangements are required in future evaluations, and 
project impact of interventions in other settings. In addition a vital output from the data will be 
an economic evaluation using dynamic cost-effectiveness models of HCV treatment among 
PWID.  These models can inform other areas and treatment scenarios. 
8.3 
 
 
7.3 
TRANSFER OF DATA 
No patient identifiable data will be transferred from NHS Tayside. 
 
 

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8 
   STUDY MANAGEMENT AND OVERSIGHT ARRANGEMENTS 
8.1    STUDY MANAGEMENT GROUP 
The study will be co-ordinated by a Management Group, consisting of the grant holder (CI), 
Study Manager, and research fellow. 
 
8.2 
STUDY STEERING COMMITTEE  
A Study Steering Committee (SC) will not be established for this study. The Erapidstudy will 
eventually form a part of a larger study with more sites (Epitope). This larger study will compare 
the measures of HCV incidence in NHS Tayside, collected as part of the Erapid study, with 
similar measures in other regions of the UK where intensive treatment regimes for HCV 
infection are not currently carried out.  A steering group will be established to oversee the 
conduct and progress of this larger study, which will include Erapid. 
 
 
8.3 
INSPECTION OF RECORDS 
The CI will permit study related monitoring, audits, and REC review. The CI agrees to allow the 
Sponsor or, representatives of the Sponsor, direct access to all study records and source 
documentation. 
 
9 
  GOOD CLINICAL PRACTICE 
 
9.1 
ETHICAL CONDUCT OF THE STUDY 
The study will be conducted in accordance with the principles of good clinical practice (GCP). 
In addition to Sponsorship approval, a favorable ethical opinion will be obtained from the 
appropriate REC and appropriate NHS R&D approval will be obtained prior to commencement 
of the study. 
 
9.2 
CONFIDENTIALITY 
All laboratory specimens, evaluation forms, reports, and other records will be identified in a 
manner designed to maintain participant confidentiality. All records will be kept in a secure 
storage area with limited access to study staff only. Clinical information will not be released 
without the written permission of the participant, except as necessary for monitoring and 
auditing by the Sponsor or its designee. The CI and study staff involved with this study will not 
disclose or use for any purpose other than performance of the study, any data, record, or other 
unpublished, confidential information disclosed to those individuals for the purpose of the study. 
Prior written agreement from the Sponsor or its designee will be obtained for the disclosure of 
any said confidential information to other parties. 
 
9.3 
DATA PROTECTION 
The CI and study staff involved with this study will comply with the requirements of the Data 
Protection Act 1998 with regard to the collection, storage, processing and disclosure of personal 
information and will uphold the Act’s core principles. The CI and study staff will also adhere, if 
appropriate, to the current version of the NHS Scotland Code of Practice on Protecting Patient 
Confidentiality.  Access to collated participant data will be restricted to the CI and appropriate 
study staff. 
Computers used to collate the data will have limited access measures via user names and 
passwords. 
Published results will not contain any personal data that could allow identification of individual 
participants. 
 

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9.4 
INSURANCE AND INDEMNITY 
 
The University of Dundee and Tayside Health Board are Co-Sponsoring the study. 
 
Insurance –The University of Dundee will obtain and hold a policy of Public Liability Insurance 
for legal liabilities arising from the study. 
 
Tayside Health Board will maintain its membership of the Clinical Negligence and Other Risks 
Insurance Scheme (“CNORIS”) which covers the legal liability of Tayside in relation to the study. 
 
Where the study involves University of Dundee staff undertaking clinical research on NHS 
patients, such staff will hold honorary contracts with Tayside Health Board which means they 
will have cover under Tayside’s membership of the CNORIS scheme. 
 
Indemnity Co-Sponsors do not provide study participants with indemnity in relation to 
participation in the Study but have insurance for legal liability as described above. 
 
10     ADVERSE EVENTS - NOT RELEVANT TO THIS STUDY 
 
11 ANNUAL REPORTING REQUIREMENTS 
Annual reporting will be conducted in compliance with TASC SOP 15: Preparing and Submitting 
Progress and Safety Reports in CTIMPs and Non-CTIMPs, as a condition of sponsorship and 
as a condition of a favourable opinion from a REC. An HRA Annual Progress Report for 
NCTIMPs will be prepared and submitted by the CI to REC, and copied to the Sponsor, on the 
anniversary date of the REC favourable opinion. 
 
 
12    STUDY CONDUCT RESPONSIBILITIES 
12.1 PROTOCOL AMENDMENTS, DEVIATIONS AND BREACHES 
The CI will seek approval for any amendments to the Protocol or other study documents from 
the Sponsor, REC and NHS R&D Office. Amendments to the protocol or other study docs will 
not be implemented without these approvals.  
In the event that a CI needs to deviate from the protocol, the nature of and reasons for the 
deviation will be recorded in the CRF, documented and submitted to the Sponsor. If this 
necessitates a subsequent protocol amendment, this will be submitted to the Sponsor for 
approval and then to the appropriate REC and NHS R&D Office for review and approval.  
In the event that a serious breach of GCP or protocol is suspected, this will be reported to the 
Sponsor Governance Office immediately 
 
12.2 STUDY RECORD RETENTION 
Archiving of study documents will be for five years after the end of study  
 
12.3 END OF STUDY 
The end of study is defined as database lock. The Sponsor or CI have the right at any time to 
terminate the study for clinical or administrative reasons.  
The end of the study will be reported to the Sponsor and REC within 90 days, or 15 days if the 
study is terminated prematurely. The CI will ensure that any appropriate follow up is arranged 
for all participants. 
A summary report of the study will be provided to the Sponsor and REC within 1 year of the 
end of the study. 
 

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13   REPORTING, PUBLICATIONS AND NOTIFICATION OF RESULTS 
13.1 AUTHORSHIP POLICY 
Ownership of the data arising from this study resides with the study team and the University of 
Dundee. On completion of the study, the study data will be analysed and tabulated, and a 
clinical study report will be prepared.  
 
13.2 PUBLICATION 
The clinical study report will be used for publication and presentation at scientific meetings. 
Investigators have the right to publish orally or in writing the results of the study. 
Summaries of results will also be made available to Investigators for dissemination within their 
clinical areas (where appropriate and according to their discretion). 
 
13.3 PEER REVIEW 
 
14 REFERENCES 
 
1. 
Hutchinson SJ, Roy KM, Wadd S, Bird SM, Taylor A, Anderson E, et al. Hepatitis C 
virus infection in Scotland: epidemiological review and public health challenges. Scott Med J. 
2006 May;51(2):8-15. 
2. 
Government S. Hepatitis C action plan for for Scotland phase II: May 2008-March 2011. 
Edinburgh, Scotland: Scottish Government; 2008. 
3. 
Roy KM, Hutchinson SJ, Wadd S, Taylor A, Cameron SO, Burns S, et al. Hepatitis C 
virus infection among injecting drug users in Scotland: a review of prevalence and incidence 
data and the methods used to generate them. Epidemiol Infect. 2007 Apr;135(3):433-42. 
4. 
Bonkovsky HL, Mehta S. Hepatitis C: a review and update. J Am Acad Dermatol. 2001 
Feb;44(2):159-82. 
5. 
Jazwinski AB, Muir AJ. Direct-acting antiviral medications for chronic hepatitis C virus 
infection. Gastroenterol Hepatol (N Y). 2011 Mar;7(3):154-62. 
6. 
D'Ambrosio R, Degasperi E, Colombo M, Aghemo A. Direct-acting antivirals: the 
endgame for hepatitis C? Curr Opin Virol. 2017 Apr 15;24:31-7. 
7. 
Martin NK, Vickerman P, Foster GR, Hutchinson SJ, Goldberg DJ, Hickman M. Can 
antiviral therapy for hepatitis C reduce the prevalence of HCV among injecting drug user 
populations? A modeling analysis of its prevention utility. J Hepatol. 2011 Jun;54(6):1137-44. 
8. 
Innes H, Goldberg D, Dillon J, Hutchinson SJ. Strategies for the treatment of Hepatitis 
C in an era of interferon-free therapies: what public health outcomes do we value most? Gut. 
2015 Nov;64(11):1800-9. 
9. 
Hutchinson SJ, Bird SM, Goldberg DJ. Modeling the current and future disease burden 
of hepatitis C among injection drug users in Scotland. Hepatology. 2005 Sep;42(3):711-23. 
10. 
Harris RJ, Thomas B, Griffiths J, Costella A, Chapman R, Ramsay M, et al. Increased 
uptake and new therapies are needed to avert rising hepatitis C-related end stage liver disease 
in England: modelling the predicted impact of treatment under different scenarios. J Hepatol. 
2014 Sep;61(3):530-7. 
11. 
Harris RJ, Martin NK, Rand E, Mandal S, Mutimer D, Vickerman P, et al. New 
treatments for hepatitis C virus (HCV): scope for preventing liver disease and HCV transmission 
in England. J Viral Hepat. 2016 Aug;23(8):631-43. 
12. 
Aspinall EJ, Mitchell W, Schofield J, Cairns A, Lamond S, Bramley P, et al. A matched 
comparison study of hepatitis C treatment outcomes in the prison and community setting, and 
an analysis of the impact of prison release or transfer during therapy. J Viral Hepat. 2016 
Dec;23(12):1009-16.