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doi:10.1111/jgh.12864

H E PAT O L O G Y

Addressing viral hepatitis in the opiate substitution setting:

An integrated nursing model of care
Vince Fragomeli* and Martin Weltman
*Department of Gastroenterology and Hepatology Services, and Drug and Alcohol Services, Nepean Hospital, Penrith, New South Wales,
Australia

Key words
model of care, opioid substitution, viral
hepatitis.
Correspondence
Mr. Vince Fragomeli, Department of
Gastroenterology and Hepatology Services,
Nepean Hospital, PO Box 63 Penrith, NSW
2751, Australia. Email:
vincenzo.fragomeli@health.nsw.gov.au
Vince Fragomeli has received travel grants
from Roche, Janssen, and MSD.
Martin Weltman has received honoraria for
participation in advisory boards sponsored by,
Janssen, MSD, Abbvie, and Gilead and for
presentations for Janssen, MSD, and Abbvie.
He has received travel grants from Roche.

Abstract
Despite the availability of effective therapies for hepatitis C virus (HCV) and B virus
(HBV), only a minority of infected patients receive treatment. In the general population,
morbidity and mortality associated with chronic HCV is now successfully being addressed
through the use of antiviral therapy. In Australia, an estimated 41% to 68% of people who
inject drugs (PWID) are HCV positive, and between 28% and 59% of users are estimated
to have been exposed to HBV. Although current treatment guidelines suggest that active
drug use should not preclude people from HCV treatment, uptake of therapy thus far has
been low. Patient, physician, social, and logistical-related barriers contribute to the low
uptake of HCV treatment among PWID. Traditional means of managing HCV infection
referral to secondary or tertiary health centershistorically has a poor track record in
increasing therapy uptake among this population. The same is true for people with chronic
HBV who inject drugs. Close to 50 000 Australians receive opioid substitution therapy
(OST) through a range of services, including public and private clinics, thus this setting is
an ideal target for identifying and treating people at risk for and already infected with HBV
and HCV. Over the last 11 years, a nursing model of care initiated by a teaching hospital
in Sydney, Australia that integrates viral hepatitis screening, assessment, and treatment into
the OST setting has enhanced access to services among the marginalized injecting drug use
population.

The rationale
Despite the availability of effective therapies for hepatitis C virus
(HCV) and B virus (HBV), only a minority of infected patients
receive treatment.1 Globally, injection drug use is responsible for
most of the existing and new cases of HCV.2,3 The prevalence of
HCV positivity globally in the injection drug use population is
estimated to be 67%, while the prevalence of HBV surface antigen
(HBsAg) positivity in this population is estimated to be 8.4%.2
In Australia, an estimated 41% to 68% of people who inject drugs
(PWID) are HCV positive,2 and between 28% and 59% of users are
estimated to have been exposed to HBV (HBV core antibody
[HBcAb-positive]) while 26% to 33% have evidence of vaccineinduced immunity (HBV surface antibody [HBsAb] 10 IU/mL
and HBcAb negative).4 Around 5% are HBsAg positive.5 The
prevalence of the latter is substantially lower than that of HBcAb
positivity because, among adolescents and young adults, the rates of
spontaneous HBsAg clearance are high, explaining the considerably lower proportion of PWID among the population with chronic
HBV compared with newly acquired infection.6
In the general population, the morbidity and mortality associated with chronic HCV is now successfully being addressed
6

through the use of antiviral therapy.7 To date, sustained virological

responses (SVR) have been achieved in around 50% to 60% of
people with chronic HCV treated with pegylated interferon (PEGIFN) and ribavirin (RBV).8 SVR is defined as no detectable HCV
in the blood 24 weeks post-treatment. This correlates to an objective cure for HCV infection.
With the advent of direct-acting antiviral (DAA) therapies offering improved tolerability and efficacy 911 and the initial successes
of non-IFN regimens,12,13 optimism is high that treatment outcomes will continue to improve, and greater than 90% cure rates
will be achieved.
Although current guidelines suggest that active drug use should
not preclude patients from HCV treatment, and response rates
among this population are comparable to those among patients not
using drugs,14,15 uptake of therapy has been low in this cohort, to
say the least.7,16

Barriers to therapy
Patient, physician, social, and logistical-related barriers contribute
to the low uptake of HCV treatment among PWID.17 Traditional
means of managing HCV infectionreferral to secondary or

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V Fragomeli and M Weltman

Viral hepatitis opium substitution setting

agents. The overarching therapeutic goal is viral suppression.

However, treatment of HBV can be challenging: the eligibility
criteria are complex, and there is a risk of antiviral resistance. In
the injecting drug use population, this can be further complicated
by coinfection with human immunodeficiency virus and the concurrent lifestyle and psycho-behavioral problems.6
Given the serious sequelae of chronic HBV, prevention is a
priority. Overall, studies indicate that 14% to 46% of PWID in
Australia are susceptible to HBV, yet many in this cohort believe
that they are immune to infection.4 The uptake of the HBV vaccine
is low in PWID. In a recent Australian study of 172 PWID, only
19% had evidence of prior vaccination. When compared with
vaccinated participants, unvaccinated susceptible PWID were significantly more likely to be male and significantly less likely to
report daily or more frequent injecting, current opioid substitution
treatment (OST), and awareness of the HBV vaccine.4

tertiary health centershas a poor track record in expanding the

population of PWID receiving HCV therapy.18 The same is true for
PWID with chronic HBV.
PWID express mistrust of the medical system 19 and find it to be
discriminatory or impenetrable.20 They often perceive health-care
providers as judgmental, condescending, and unresponsive to their
needs. For these reasons and/or other patient characteristics such
as concomitant psychiatric disorders and lack of knowledge about
HBV/HCV, PWID may fail to adhere to medical advice and prescribed therapies, as well as miss scheduled appointments.21
On the other hand, physicians not based in clinics that specialize
in care of the injecting drug population often fear being deceived
by PWID and express discomfort and uncertainty in how to
approach them.19 PWID frequently have comorbid psychiatric
conditions including major depression, anxiety disorders, posttraumatic stress disorder, and bipolar disorder, which can present
special challenges to the health-care team.21
Furthermore, medical concerns about treating PWID have centered around increased susceptibility to side effects and the risk
of reinfection.14,15 Antiviral therapy with IFN may lead to or
exacerbate psychiatric side effects, impacting quality of life and
adherence.22
The potential for drugdrug interactions with emerging HCV
therapies and drug-induced hepatotoxicity have made some health
professionals reluctant to initiate therapy in the injecting drug
population.
Reinfection after successful HCV treatment can occur as there is
no vaccination available, and treatment does not lead to immunity.
However, studies suggest that the risk of reinfection is relatively
low, even among people who continue to inject drugs during and
after treatment.15
As is the case with HCV, the consequences of chronic HBV
infection can be serious, leading to advanced liver disease and in
some cases the development of hepatocellular carcinoma (HCC).
However, unlike HCV, HBV cannot be cured. In Australia, there is
an increasing number of liver transplants and rising mortality as a
direct consequence of HBV-related HCC. Treatment revolves
around immunomodulatory agents (e.g. PEG-IFN) and DAA

25

Viral hepatitis-positive patients in the

OST setting
Close to 50 000 Australians receive OST through a range of services, including public and private clinics. Around half of these
people actively inject drugs, and the remainder are former users.
The prevalence of HCV infection is between 75% and 80% in
patients on OST, with half of these having chronic HCV. Thus, it
is estimated that in the OST setting there are around 24 000 people
with chronic HCV infection, of whom approximately half would
be active users.23 It is not clear what proportion of patients in the
OST setting are HBV positive.
The prospective, observational Enhancing Treatment for Hepatitis C in Opioid Substitution Settings (ETHOS) study offers
insights into the barriers and motivators of HCV-positive patients
in the OST setting. Although 331/387 (86%) of participants were
definitely or somewhat willing to receive treatment, 213/387
(59%) had never previously sought HCV treatment. The most
common reason for not seeking treatment was lack of knowledge
about HCV (Fig. 1).18

23

20
Percent of paents

17
14

15

10

0
Figure 1 Most common reasons for patients
not seeking hepatitis C virus treatment.18

Lack of knowledge

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Concerns about side

eects

Asymptomac disease

Viral hepatitis opium substitution setting

V Fragomeli and M Weltman

When asked whether they planned to start HCV treatment, 282

(74%) participants in the ETHOS study indicated they planned to
do so in the next 12 months; 51 (13%) in the next one to two years;
and 31 (8%) in the next two to five years.18 Factors shown to be
associated with lower or no HCV therapy uptake after referral to a
specialist included minority ethnicity, living alone, and methamphetamine use.18
A study conducted in 2011 in four major Australian centers
demonstrated that HCV-positive patients on opioid replacement
therapy, even if they continue to inject actively, can achieve comparable SVR rates to other populations with PEG-IFN/RBV
therapy. In addition, these patients suffer no excess rates of adverse
effects or psychological complications. One of the most encouraging results in this difficult-to-treat population was the high
adherence rate. A total of 85% of patients achieved the accepted
optimum level of 80% of PEG-IFN and 80% of RBV for 80% of
treatment duration, rates similar to those reported in non-injecting
drug use populations.24 Direct observation of treatment administration in the OST clinic facilitated adherence and compliance.
A variety of models in OST settings using multidisciplinary
treatment (MDT) approaches have been successful in delivering
HCV therapy to drug using populations.18 In this paper, we look at
an Australian initiative that established a holistic, MDT viral
hepatitis-focused service within an OST setting for patients living
with HBV/HCV.

A model for viral hepatitis care in the

OST setting
Genesis. PWID in an OST setting, as is the case in the general
population of drug users, have limited access to viral hepatitis care
services. As noted earlier, this is in part attributable to reluctance to
attend specialized services because of fears of stigma and discrimination. Apathy, chaotic lifestyles, comorbidities, inaccurate
information about the risks of acquiring viral hepatitis, and inadequate understanding of treatment options also contribute to poor
assessment and treatment uptake in the OST population.
Located within the Blue Mountains Local Health District in
NSW, Nepean Hospital Liver Clinic comprises an outpatient clinic
and satellite outreach clinics which serve to meet the needs of
patients living with viral hepatitis and other related liver disorders.
The clinic follows a nursing model of care, where the majority of
care is provided by nurses, with regular consultation and liaison
with doctors. The nurses act as case managers, developing care
plans and coordinating patient care. They also act as a vital link
between the liver clinic, drug and alcohol, OST, and mental health
services.
Recognizing that HCV, and to a lesser extent, HBV is highly
prevalent in the injecting drug use population, the Nepean Liver
Clinic developed a model of care designed to break through the
barriers that prevent PWID living with viral hepatitis accessing
appropriate care. As OST clinics offer the opportunity to identify
a large pool of affected patients, the Nepean initiative was
designed to target PWID and OST patients in this setting.

Aims. The strategic objectives of the Nepean Liver Clinic model

of care for people living with HBV/HCV treated at OST clinics are
8

to reduce the number of people contracting viral hepatitis by

enhanced prevention and intervention strategies and increase the
number of people receiving treatment.
In practical terms, the overarching goal of the Nepean model is
to establish a holistic, MDT viral hepatitis-focused service within
an OST setting for people living with HBV/HCV. Under this
umbrella the model is designed to:
Address an unmet need
Increase awareness of the risk for HBV/HCV in a vulnerable
population
Facilitate diagnosis of HBV/HCV
Promote liver healthy lifestyles through initiatives such as
alcohol counselling and dietary advice
Minimize the spread of HBV/HCV
Enhance treatment uptake within a safe and familiar environment
Conduct liver disease monitoring
Improve quality of life for this marginalized group
Reduce fear, stigma, and discrimination
Establish collaborative relationships with OST drug and alcohol
workers
Strategy. Having identified the goals of the model, the Liver
Clinical team had to ensure that they had adequate staff and
funding. The next step was to have preliminary meetings with the
Local Health District Drug and Alcohol Services administration.
Once the latter had agreed to the concept, the Liver team initiated
discussions with hospital management staff at Local Health District satellite OST clinics. In addition, it was necessary to liaise
with satellite pharmacy and pathology services.
A case plan was developed outlining the overall concept of
the model, resources needed, potential challenges, and expected
outcomes. The case plan was approved in 2003. Since then, the
model has been refined and enhanced to reflect lessons learned and
changing patient needs, as well as advances in therapeutic
regimens.
Resources and logistics. In order to successfully implement an HBV/HCV nursing model of care based in satellite OST
clinics, the Nepean Liver team needed first and foremost managerial support from the Liver Clinic and OST clinics. Without this,
the inevitable roadblocks, unforeseen expenses, and learning curve
associated with the initiative could have easily derailed the project.
Logistical resources necessary include regular access to a hospital car and suitable clinic space for assessing and treating
patients within the OST clinic. Obviously, privacy is an issue, and
thus it is essential that clinic space devoted to HBV/HCV services
is of a nature that confidentiality is maintained.
Ensuring that local pathology services are equipped to test for
HBV/HCV and pharmacies are able to provide immunomodulatory
and antiviral therapies is an essential component. An important first
step is to provide education on HBV/HCV for OST staff and key
stakeholders as they are frequently not aware of the high prevalence
in the injecting drug use population or of the advances in treatment,
particularly in HCV.
Placing notices and fliers in OST clinics alerting patients to the
availability of HBV/HCV testing, counselling, and treatment is

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V Fragomeli and M Weltman

helpful as clinic staff may not always feel comfortable raising the
issue. The Liver Clinic teams calendar of HCV/HBV clinics
scheduled at the OST clinic is prominently displayed, with contact
information available.
One of the keys to success was to reassure OST staff that Liver
Clinics were not going to add to their already heavy workload. For
example, it is the responsibility of Liver Clinic team members to
collect bloods and initiate therapy as prescribed. Nevertheless,
ongoing collaboration and communication with OST staff is
crucial. It is essential OST staff be kept in the loop. Thus, if OST
nursing staff are agreeable, they can directly administer therapy
such as PEG-IFN/ribavirin when dispensing OST. This enhances
compliance. They also remind patients about Liver Clinic appointments and generally act as cheerleaders, offering encouragement
and congratulations as milestones are met. OST staff can also alert
Liver Clinic nurses if a patient shows signs of non-compliance or
exhibits side effects, such as psychiatric disturbances. Early recognition of potential problems allows the Liver Team to intervene
and assess the patient.
Areas of focus. The Nepean Liver Clinic Model focuses on
the areas of prevention, testing, and treatment. Standard information and counselling provided to PWID is elucidated extensively in
the medical literature, thus it is beyond the scope of this paper to
elaborate in depth. The following gives a snapshot of some of
the key points covered by team members. It is particularly important that PWID are thoroughly assessed for any psychosocial
behaviors or psychological problems that would suggest they
would not be able to cope with either a positive test result or adhere
to any treatment regimens recommended, particularly IFN-based
therapy.
Prevention. Patients are informed of the risks of being infected
with HBV or HCV and counselled regarding risk behavior that
increases the likelihood of infection. In particular, patients are
made aware of the availability of needle exchange services and the
HBV vaccine.
Testing and post-testing counselling. The testing procedure
is outlined to the patient and, most importantly, the implications of
results (e.g. positive, negative, the probability of false positives,
and indeterminate results) are discussed. The probability of a positive test is explained based on individual patients risk assessment.
The possible response of the patient to test outcomes is
assessed, in consultation with OST staff and an evaluation of the
level of support available to the patient in the home setting
conducted.
To make an informed decision about testing, patients need to
know the potential health outcomes relative to a positive result as
well as the range and relative success of treatment options.
Post-test counselling provides clinicians with the opportunity to
clarify information already provided to the patient, reinforce risk
factors for further transmission of the infection, and further cement
the clinicianpatient relationship.
Additional appointments and referrals to appropriate support
services can be made at this point. A further review of the types
of therapies available and their likelihood of success is also
appropriate.

Viral hepatitis opium substitution setting

Fibroscan testing is administered by Liver Team nursing staff to

assess and monitor liver disease progression. Results can drive the
treatment decision. If patients have only mild liver disease as
reflected by a low Fibroscan score, they may elect to watch and
wait before initiating current interferon-based therapies. On the
other hand, if moderate-to-severe liver disease is present, patients
should be urged to consider immediate treatment. Fibroscan
avoids the need for a liver biopsy which many patients in the OST
setting would refuse to undergo having heard from others of the
pain and discomfort associated with it.
Treatment. If patients decide to start therapy, it is important to
determine if they understand the information provided previously
about the probability of success and potential side effects. At this
stage, a management plan should be developed in collaboration
with the patient, including frequency of follow-up appointments
and blood testing. OST staff are notified that treatment is being
initiated.
Careful assessment of a patients underlying hepatic function,
comorbidities, including psychological state, and concomitant
medications is essential before initiating therapy. Once a patient
has started therapy, every effort must be made to ensure that they
comply as missed doses can reduce the chances of achieving
clearance with HCV and increase the risk of antiviral resistance in
those with HBV.
The MDT plays an ongoing role in patient management.
Regular psychological assessment is performed, as well as dietary
counselling. Liver enzyme levels are monitored regularly. New
OST staff, including registrars and ancillary staff, are educated
about the operation and functioning of the Liver Clinic as well as
HBV/HCV. In addition, the Liver Clinic Team frequently conducts
educational sessions for local general practitioners (GPs), alerting
them to the prevalence of HBV/HCV and the advances in therapy
that promise to reduce the burden of liver disease in the PWID
population.

Outcomes
Now on its 11th year, the initiative has successfully reviewed in
excess of 300 patients living with viral hepatitis. Therapy has been
initiated in approximately 40 patients.
One of the most gratifying outcomes has been the increase in
referrals by GPs. A concentrated education program has raised
awareness among GPs of the extent of the problem of viral
hepatitis-related disease in the community.
A key feature of the success of the initiative is the ability of
patients to access treatment at satellite clinics. Ensuring that local
pathology and pharmacy services are equipped to offer appropriate
blood testing and medications, respectively, has helped these
clinics retain patients. Collaboration with drug and alcohol, OST,
and mental health services has also been an important element.
Nevertheless, one of the major hurdles that the initiative has faced
is the inconsistent attendance of PWID and OST patients at OST
clinics. This makes follow-up and monitoring difficult and
increases the likelihood of treatment failure.

Discussion
Viral hepatitis remains a major health problem, particularly in the
injecting drug use population. The rapid advances in HCV therapy

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V Fragomeli and M Weltman

provide the potential to cure HCV infection in the vast majority of

people treated. However, treatment efficacy (>90%) does not
match treatment effectiveness, given that less than 10% have been
treated in most countries. Thus, unless the numbers of people
screened, assessed, and treated for HCV infection are increased,
the advanced therapies now available will have limited impact.23
The burden of disease in people with chronic HBV is high, with
around 30% dying of liver cancer or liver disease. As more and
more immigrants from HBV endemic countries arrive in Australia,
the population risk will continue to grow. Engaging at-risk communities heightens awareness and encourages participation in
disease-control programs. One HBV screening program demonstrated that with only a 58% participation rate, the death rate from
primary liver cancer was reduced by 37%.25 The initiation of
antiviral therapy facilitated by the New Zealand Hepatitis B Programme has averted the need for liver transplantation among a
number of patients.26
It is becoming clear that attempts to reduce the prevalence of
HCV in the injecting drug use population should be largely
focused on harm reduction and treatment programs within the
framework of needle syringe programs (NSP) and OST clinics.
Research suggests that a substantial number of infections have
been averted by harm reduction programs and educating PWID on
how to avoid infection. However, such prevention programs fail to
address the needs of the large number of PWID already infected.23
It has been estimated that the strategy of coupling HCV treatment with OST clinics and NSP could achieve large reduction rates
(>45%) in chronic prevalence over 10 years. Substantial reductions in prevalence are unlikely with OST and NSP alone without
HCV treatment.27
In Australia, the ETHOS study demonstrated that when HCV
specialist and nursing support are integrated into OST or community health clinics, a substantial number of former PWID choose to
receive HCV therapy. A total of 236 (61%) patients were referred to
an HCV specialist, of whom 191 (81%) attended the appointment.
Following specialist assessment, HCV therapy was recommended
and commenced in 84 (44%) patients who were seen by a specialist.
The median time between study enrolment and HCV therapy initiation was 0.2 years (range 02).18 Treatment uptake was much
higher than that previously reported for drug user cohorts in the
community (1% to 6%).18 The ETHOS findings are consistent with
other Australian data and reports from Canada, Europe, and the
United States on programs that provide appropriate infrastructure
for screening, testing, assessment, and treatment.23
The Nepean Liver Clinic model of viral hepatitis care integrated
within satellite OST clinics offers people living with viral hepatitis
a one-stop viral hepatitis shop where they can be tested, counselled, and treated in a nonjudgmental, non-discriminatory, and
confidential environment. The synergy between the OST setting
and Liver Clinic has the potential to enhance the uptake of and
compliance with both opiate substitution agents and viral hepatitis
treatments.

Conclusions
Local district healthcare networks provide an opportunity to integrate services necessary for viral hepatitis management among
target populations, such as PWID. The most successful programs
10

are built on the foundation of existing infrastructures such as OST

clinics.
Multidisciplinary teams with members from hepatology,
nursing, drug and alcohol, pathology, pharmacy, dietetics, social
work, and mental health disciplines enhance patient care through
models for best practice and collaborative patient management. In a
supportive environment, viral hepatitis assessment and management among injecting drugs users can be successfully implemented.

Acknowledgments
The authors would like to thank Jo Stratmoen for editorial assistance in the preparation of this paper.

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