International Journal of Drug Policy 26 (2015) 893–898
Contents lists available at ScienceDirect
International Journal of Drug Policy
journal homepage: www.elsevier.com/locate/drugpo
Editorial
Expanding access to prevention, care and treatment for hepatitis C virus
infection among people who inject drugs
In high income countries, the majority of new and existing cases
of hepatitis C virus (HCV) infection occur among people who inject
drugs (PWID), and epidemics in many low and middle income
countries are increasingly concentrated among PWID (Hajarizadeh, Grebely, & Dore, 2013). HCV transmission continues among
PWID in many settings (Hagan, Pouget, Des Jarlais, & LelutiuWeinberger, 2008; Page, Morris, Hahn, Maher, & Prins, 2013;
Wiessing et al., 2014). However, high coverage of combined harm
reduction programs (opioid substitution treatment [OST] and
needle and syringe programs [NSP]) (Degenhardt et al., 2010;
Hagan, Pouget, & Des Jarlais, 2011; MacArthur et al., 2014; Turner
et al., 2011; van den Berg et al., 2007) and OST alone (Aspinall et al.,
2014; Nolan et al., 2014; Tsui, Evans, Lum, Hahn, & Page, 2014;
White, Dore, Lloyd, Rawlinson, & Maher, 2014) can reduce HCV
incidence. The high HCV prevalence and ageing PWID population
in many settings has led to a continued rise in liver disease burden
among PWID (Grebely & Dore, 2011; Hajarizadeh et al., 2013).
The core problem is that many PWID remain HCV undiagnosed
and un-linked to HCV prevention, care and treatment. Barriers to
care at the level of the patient, provider and systems levels
(Bruggmann & Grebely, 2015; Grebely & Tyndall, 2011; Harris &
Rhodes, 2013; Harris, Rhodes, & Martin, 2013) have resulted in low
HCV treatment uptake among PWID in many settings (Alavi et al.,
2014; Iversen et al., 2014; Strathdee et al., 2005; Wiessing et al.,
2014). However, broadened HCV treatment access in many
populations has been limited by criminalisation of drug use,
discrimination and stigma in health settings and arduous, poorly
tolerated interferon-based therapies. Simple, well-tolerated oral
directly acting antiviral (DAA) HCV therapies with near optimal
efficacy have now been developed and have the potential to
produce one of the major turnarounds in disease burden seen in
public health and clinical medicine.
As we move forward, control of HCV infection among PWID will
require targeted strategies to enhance HCV diagnosis, link
individuals into HCV care, increase treatment uptake and enhance
viral cure, collectively termed the ‘‘HCV cascade of care’’ (Fig. 1).
Globally, a major challenge will be to develop and implement
programs appropriate for different settings, including low- and
middle-income countries.
Original research articles, systematic and expert reviews, and
commentaries focused on ‘‘Expanding access to prevention, care
and treatment for HCV infection among PWID’’ have been collated
as part of two special and themed issues published in the
International Journal of Drug Policy. These were commissioned in
http://dx.doi.org/10.1016/j.drugpo.2015.07.007
0955-3959/ß 2015 Elsevier B.V. All rights reserved.
collaboration with the International Network for Hepatitis in
Substance Users (INHSU), an international organization dedicated
to scientific knowledge exchange, knowledge translation, and
advocacy focused on HCV prevention and care among PWID. This
guest-edited special issue is focused on the epidemiology and
prevention of HCV infection among PWID (including HCV
treatment as prevention), and enhancing HCV testing, linkage to
care and treatment for PWID. This includes updated international
recommendations for the clinical management of HCV infection
among PWID. In the following issue (volume 26, issue 11), we
publish a collection of papers on the theme of access to HCV
prevention and care for PWID, including strategies for achieving
universal access (Doyle et al., 2015; Hutchinson et al., 2015;
Luhmann et al., 2015; Wolfe et al., 2015; Perlman et al., 2015; Coats
and Dillon, 2015; Ford et al., 2015).
Epidemiology and prevention of HCV infection among PWID
Efforts to expand access to HCV prevention, care and treatment
among PWID require enhanced clarity of the definitions used to
define specific populations of PWID. As outlined by Larney et al.,
gaining a greater understanding of those who have ‘ever’ injected
drugs, including those who did so for a short duration or
infrequently, is important to characterize HCV disease burden
among PWID (Larney et al., 2015). As shown in Fig. 2, within this
population of those ever injecting drugs are ‘current’ or ‘recent’
PWID, who may be at risk of transmitting and acquiring HCV
infection. ‘Former’ PWID (people who have permanently ceased
injecting drug use) are also of importance, as a large proportion of
existing HCV infections occur in this group. There are also people
who may continue to use drugs, but no longer inject. People in any
of these populations may also be receiving OST. Larney et al.
highlight that understanding and estimating the size of PWID
populations, and parameters related to injecting drug use and
settings where PWID may be reached is often difficult, but
necessary to inform HCV prevention and treatment strategies
(Larney et al., 2015).
HCV prevalence among populations of PWID ranges from <20%
to >80% (mid-point HCV estimate: 67% antibody positive; 50% RNA
positive), with a global estimate of 10 million HCV antibody
positive PWID (7.5 million with chronic HCV infection) (Hagan
et al., 2008; Nelson et al., 2011), with an additional large reservoir
of infection among former PWID. Considerable HCV transmission
continues in many settings, with HCV incidence among PWID
894
Editorial / International Journal of Drug Policy 26 (2015) 893–898
Fig. 1. The HCV cascade of care.
varying considerably from 2% to 66% per annum (Hagan et al.,
2008; Page et al., 2013; Wiessing et al., 2014).
As highlighted in the revised international recommendations
for the management of HCV infection among PWID (Grebely et al.,
2015), high coverage of combined OST and NSP programs can
reduce HCV incidence (Degenhardt et al., 2010; Hagan et al., 2011;
MacArthur et al., 2014; Turner et al., 2011; van den Berg et al.,
2007). Recent evidence has also corroborated the impact of OST
alone, reporting HCV transmission reductions by 50–80% (Aspinall
et al., 2014; Nolan et al., 2014; Tsui et al., 2014; White et al., 2014).
Additional beneficial effects of OST dose–response (Nolan et al.,
2014) and adjunct therapy during OST (Wang et al., 2014) have also
been observed. As suggested by Perlman and colleagues, achieving
reductions in HCV prevalence/transmission to very low levels will
require: (1) maintaining an expanding current levels of combined
harm reduction services such as OST and NSP; (2) expanding
Fig. 2. Populations of people who inject drugs (PWID, people who inject drugs; OST,
opioid substitution therapy).
efforts to reduce the stigmatization of drug use; (3) expanding use
of OST as part of a coordinated public health approach to opioid
dependence, HIV prevention, and HCV control efforts; and (4)
reductions in HCV treatment costs and expanded health system
coverage to allow population-level HCV treatment as prevention
(Perlman et al., 2015). In this issue, a study of recent PWID
attending NSP programs by Artenie et al. demonstrated that
visiting a primary care physician was also associated with a lower
risk of HCV infection (Artenie et al., 2015). Further prospective
studies are needed to evaluate other interventions that can be
combined with both OST and NSP to enhance HCV prevention
among PWID (for example, engagement in primary care as
described above and stimulant substitution therapy).
Several modelling studies suggest that HCV treatment for PWID
can lead to substantial reductions in HCV prevalence and reduce
transmission (de Vos, Prins, & Kretzschmar, 2015; Hellard et al.,
2014; Martin, Hickman, Hutchinson, Goldberg, & Vickerman,
2013a; Martin et al., 2011, 2013b), particularly when combined
with NSP and OST (Martin et al., 2013b). In a study of PWID with
recent HCV infection by Alavi et al., HCV treatment was not
associated with increased drug use or used needle and syringe
borrowing during follow-up, but was associated with decreased
ancillary injecting equipment sharing (Alavi et al., 2015).
Collectively, these results support the integration of HCV
treatment within a strong foundation of existing prevention and
health care services for PWID.
There are two clinical trials evaluating HCV treatment as
prevention underway in the prison [Surveillance and Treatment of
Prisoners with Hepatitis C (SToP-C) study (NCT02064049)] and
among PWID in the community [Treatment and Prevention (TAP)
Study (NCT02363517)] in Australia. The SToP-C study is evaluating
whether a rapid scale-up of IFN-free therapy can lead to reductions
in the incidence and prevalence of HCV infection in a network of
prisons in New South Wales, Australia. As summarized by Hellard
et al., the TAP study is evaluating whether a ‘‘bring a friend’’ HCV
treatment strategy will lead to a lower incidence of transmission of
HCV from primary participants to their injecting partners,
compared to not treating any PWID (Hellard et al., 2015). As
Harris and colleagues highlight, HCV treatment as prevention
strategies require a foundation of enhanced harm reduction access
(including NSP and OST), meaningful community engagement, and
Editorial / International Journal of Drug Policy 26 (2015) 893–898
enabling environment interventions informed by the needs and
perspectives of PWID (Harris et al., 2015).
At the population-level, HCV treatment as prevention may have
the greatest impact on reducing the prevalence and incidence of
HCV infection in the long term if therapy is targeted to groups and
settings associated with the highest risk of transmission (Grebely,
Matthews, Lloyd, & Dore, 2013). However, at the individual-level,
HCV treatment may have the greatest impact on disease morbidity
and mortality if targeted to those PWID who have already been
infected with HCV for many years with the greatest risk of disease
progression and death (Grebely et al., 2013).
In a systematic review of the progression of fibrosis among
PWID with chronic HCV by Smith et al., the average time from HCV
infection to the development of advanced liver disease (stage F3)
and cirrhosis were 29–30 years and 39–40 years, respectively
(Smith et al., 2015). Given a large proportion of PWID have been
HCV-infected for two or more decades, many have progressed to
advanced fibrosis (Grebely & Dore, 2011; Hajarizadeh et al., 2013).
Rates of advanced liver disease complications, associated healthcare costs, and liver-related morbidity and mortality among PWID
continue to rise (Grebely & Dore, 2011; Hajarizadeh et al., 2013). As
discussed by Whiteley et al., HCV infection is also associated with
impaired quality of life (Whiteley et al., 2015). Fortunately,
successful HCV treatment is associated with long-term viral
eradication, improvement in health related quality of life,
regression and reversal of hepatic fibrosis, reduced risk of
advanced liver disease complications, and improved survival
(Hajarizadeh et al., 2013; Whiteley et al., 2015).
Enhancing HCV testing, linkage to care and treatment for PWID
As highlighted by Martinello and Matthews, detection of HCV
infection has been hampered by its asymptomatic or non-specific
presentation, lack of specific diagnostic tests and the inherent
difficulties in identifying and following individuals at highest risk
of transmitting and acquiring HCV, including PWID (Martinello
and Matthews, 2015). Reducing the burden of HCV infection
among PWID will require targeted strategies focused on different
stages of the HCV Cascade of care (Fig. 1). In this issue, Meyer et al.
performed a systematic review of evidence-based strategies to
enhance HCV diagnosis/testing, linkage to HCV care, HCV
treatment and viral cure (including enhanced adherence) (Meyer
et al., 2015).
Successful strategies to increase HCV testing and diagnosis
include interventions based on targeted case-finding (Cullen et al.,
2012), risk-based assessment (Drainoni et al., 2012; Litwin et al.,
2012), birth-cohort screening (Litwin et al., 2012), and motivational interviewing with case management (Masson et al., 2013).
Enhanced screening could also be achieved through targeted HCV
testing initiatives such as free counselling and testing, point-ofcare testing, and dried blood spot testing (Meyer et al., 2015). In a
systematic review of interventions incorporating dried blood spot
testing in drug and alcohol clinics, prisons or NSP services by Coats
and Dillon, five of the six studies provided evidence that the
introduction of DBS testing increased the number of tests, new
diagnoses or both (Coats and Dillon, 2015). HCV RNA point of care
testing may also be a valuable strategy for enhanced testing and
diagnosis among PWID. Point of care HCV RNA testing would
enable HCV RNA confirmation and diagnosis in a single visit. Future
research should focus on the systematic evaluation of POC HCV
RNA testing a strategy to enhance linkage to HCV care among
PWID.
Screening for liver disease may also enable enhanced linkage to
HCV care among PWID. Assessment of HCV-related liver disease
has been long complicated by the fact that liver biopsy is invasive
and logistically difficult. But, the availability of non-invasive
895
fibrosis assessment methods such as transient elastography (e.g.
Fibroscan1) has greatly improved the ease of liver disease
assessment. In one study of a liver health promotion campaign
using transient elastrography-based assessment among PWID in
drug and alcohol clinics by Marshall et al., 95% reported that
transient elastography was an acceptable method of liver disease
assessment (Marshall et al., 2015). Transient elastography has
been shown to be effective for enhancing liver disease screening
among PWID attending drug and alcohol clinics in other settings
(Foucher et al., 2009; Moessner et al., 2011). Increased communitybased liver disease screening using transient elastrography might
be one useful strategy for linking PWID in HCV care and triaging
those with advanced liver disease who are in most need of
immediate treatment.
Successful strategies for enhanced linkage to HCV care for PWID
includes the integration of HCV testing and care into existing
health care services for PWID, including drug and alcohol, primary
care, and prison-based settings (Meyer et al., 2015). In a
randomized controlled trial examining the efficacy of a hepatitis
care coordination model (including motivational interviewingenhanced patient navigation and case management services) in the
OST setting, participants receiving the intervention were four
times more likely to receive assessment for HCV infection (Masson
et al., 2013). In a study of HCV assessment and treatment among
PWID attending OST clinics by Fortier et al., poor social functioning
was common among PWID and was associated with reduced early
HCV treatment intent and specialist assessment, suggesting that
enhanced support prior to treatment may be important for
improving linkage to HCV care (Fortier et al., 2015). It has been
demonstrated that disadvantaged subgroups of PWID are less
likely to seek health care by fear of stigma, discrimination,
judgemental attitudes, and misunderstanding of their needs and
their lifestyle by healthcare providers (Neale, Tompkins, & Sheard,
2008; Ostertag, Wright, Broadhead, & Altice, 2006). As such, a
trusted HCV peer-support worker, nurse, or specialist may
facilitate addressing patient barriers to HCV care related to social
functioning that might be present at the time of treatment
contemplation or prior to engagement with an HCV specialist
(Treloar, Rance, Dore, & Grebely, 2014).
Peer-support programs have been successful in providing the
social support necessary to enhance linkage to HCV care (Crawford
& Bath, 2013; Grebely et al., 2007; Keats et al., 2015; Roose,
Cockerham-Colas, Soloway, Batchelder, & Litwin, 2014; Treloar
et al., 2015). They have also been shown to reduce patients’
mistrust in the health care system, address barriers to HCV
treatment through discussions with workers and peers, and
improve knowledge about HCV and treatment (Crawford & Bath,
2013; Keats et al., 2015; Roose et al., 2014; Treloar et al., 2015). In a
qualitative evaluation of two community-controlled peer support
services in OST clinics in Australia, Treloar et al. found that the peer
support services were acceptable to both clients and clinic staff,
met its goals of engaging clients, building trusting relationships
and providing instrumental support for clients to access HCV
treatment (Treloar et al., 2015). As described by Keats et al., the
time spent by the integrated HCV peer support worker at one of
these OST clinics was primarily focused on providing education
about HCV and its treatment, facilitating referrals for HCV
assessment and providing support to encourage attendance for
phlebotomy and clinic visits, allowing for the diversion of nursing
time to focus on HCV clinical assessment and treatment (Keats
et al., 2015). However, as highlighted by Meyer et al., despite the
promise of peer-based interventions for enhancing linkage to HCV
care, data are generally limited and primarily descriptive with few
randomized or controlled studies measuring or reporting the
impact of peer-driven interventions (Crawford & Bath, 2013).
Despite their success, systematic evaluations of the impact of HCV
896
Editorial / International Journal of Drug Policy 26 (2015) 893–898
peer programs are needed, including how they affect uptake and
treatment outcomes, and how different models of peer involvement may suit various settings.
Programs most successful in treating HCV infection among
PWID have often been built upon existing medical infrastructures
for drug user health (e.g. community health centres, OST clinics,
primary care) (Bruggmann & Litwin, 2013). In Canada, several
successful HCV care models have been developed in Victoria
(Milne et al., 2015) and Toronto (Mason et al., 2015) within
community health centres with extensive health care and other
services targeted for PWID. In the study by Mason et al., among
participants enrolled in primary health care centres with
integrated specialist support, during the study period, significant
increases were observed in the proportion of people assessed by an
HCV specialist, having stable housing and having receiving income
from provincial disability benefits (Mason et al., 2015). This study
demonstrates that a multi-disciplinary, community-based model
of HCV treatment can improve the lives of PWID in ways that
extend beyond HCV. The common theme from this spectrum of
HCV care models among PWID, is that ‘‘one size does not fit all’’
(Bruggmann & Litwin, 2013). When barriers are systematically
addressed within a supportive environment, HCV assessment and
treatment among PWID can be very successful.
There is now compelling evidence that interferon-based HCV
treatment is safe and effective for PWID (Aspinall et al., 2013;
Dimova et al., 2013; Hellard, Sacks-Davis, & Gold, 2009; Robaeys
et al., 2013). In two systematic reviews of interferon-based studies
assessing treatment for PWID (one specifically focusing on those
with recent injecting at the time of treatment initiation), the
overall sustained virological response (SVR) was 56% (Aspinall
et al., 2013; Dimova et al., 2013). These response rates are
comparable to responses in non-drug using populations in large
randomized controlled trials of interferon-based treatment
(Manns, Wedemeyer, & Cornberg, 2006). In this issue, Litwin
and colleagues present some of the first data on the use of peginterferon/ribavirin in combination with the first generation DAA
therapies boceprevir and telaprevir among recent PWID engaged
in OST, with an overall SVR of 62%, similar to results from clinical
trials in non-PWID (Litwin et al., 2015).
Enhancing the proportion of PWID with cure will be facilitated
by the availability of simple, well-tolerated and high efficacious
DAA-based interferon-free therapies. Although data on the use of
novel DAA-based therapies among current PWID is limited, there
are some data among people receiving OST. As highlighted in the
updated HCV recommendations in this issue, in phase II/III clinical
trials, SVR is similar among people receiving OST as compared to
those not receiving OST (Jacobson et al., 2014; Mangia et al., 2013;
Puoti et al., 2014). Among participants in phase II/III clinical trials
receiving OST with HCV genotype 1, SVR was 94% in those treated
with ledipasvir and sofosbuvir (with or without ribavirin)
(Jacobson et al., 2014), and 96% in those treated with paritaprevir/ritonavir, ombitasvir, dasabuvir (with or without ribavirin)
(Puoti et al., 2014). Similarly, in a study of genotype 1 participants
receiving OST (n = 38) treated with the all oral combination of
paritaprevir/ritonavir, ombitasvir, dasabuvir, and ribavirin, the
overall SVR was 97% (Lalezari et al., 2015).
Successful strategies to ensure adherence to therapy will be
important to optimize the proportion achieving viral cure. In their
systematic review, Meyer et al. describe several interventions that
have been demonstrated to be successful in enhancing adherence
to HCV therapy including directly observed therapy (observe only
the morning dose of ribavirin or weekly injections of interferon),
and multidisciplinary support programs (Meyer et al., 2015).
Further research is needed to explore other interventions which
have been successful for enhancing adherence to HIV therapy,
including adherence management strategies (pill boxes, electronic
reminders), peer-based support and counselling at point of ART
delivery, case management and nurse counselling, and incentives
or contributions to food/transport costs (Binford, Kahana, & Altice,
2012).
High pricing of well-tolerated, highly efficacious all-oral HCV
regimens and high demand (actual or anticipated) has led many
State Medicaid committees and some private payers in the United
States to implement restrictions that exclude those who have
recently used illicit drugs, injecting drugs, or are receiving OST; and
those with heavy alcohol use or those with alcohol misuse from
receiving new potentially life-saving HCV therapies (irrespective of
disease stage) (Barua et al., 2015). Justifications for these restrictions
that have been given are: that PWID and those with alcohol misuse
cannot adhere to the treatment regime; that they have worse
outcomes than other patients at comparable disease stages; a higher
likelihood of HCV re-infection; and that there is a lack of data on
treatment outcomes with the new interferon-free HCV therapies in
this population (Grebely, J Hepatol 2015 in press). Decisions to
provide new HCV treatments to people with drug and alcohol use,
including PWID, must be undertaken on the basis of clinical and
public health requirements rather than a common co-existing
disorder, such as addiction (Grebely, J Hepatol 2015 in press).
International guidelines from the American Association for the
Study of Liver Disease (AASLD)/Infectious Diseases Society of
America (IDSA), the European Study for the Association of the Liver
(EASL), the International Network for Hepatitis in Substance Users,
and the World Health Organization all recommend treatment for
HCV infection among people who use drugs (AASLD/IDSA, 2015;
European Association for Study of Liver, 2014; Robaeys et al., 2013;
WHO, 2014) (Grebely et al., 2015). In fact, international
recommendations also suggest that PWID should be a priority
population, given the potential prevention benefits of treatment
(AASLD/IDSA, 2015) (Grebely et al., 2015). As such, PWID should
not be withheld from HCV treatment.
Conclusions
This is an exciting era for the field of HCV. As newer IFN-free
DAA agents become available, strategies to address HCV infection
among PWID will need to be integrated into existing foundations
for prevention and health care for PWID, in partnership with the
affected community and with a commitment to tackling stigma
and discrimination associated with injecting drug use and HCV. It
is hoped that this collection provides important information to
help move this agenda forward, while stimulating discussion for
achieving global control of HCV and substantially reduce the global
burden of HCV-related disease among PWID.
Financial support
The Kirby Institute and the Centre for Social Research in Health
are funded by the Australian Government Department of Health
and Ageing. The views expressed in this publication do not
necessarily represent the position of the Australian Government.
JG is supported by a National Health and Medical Research Council
Career Development Fellowship. GD is supported by a National
Health and Medical Research Council Practitioner Research
Fellowship.
Disclosures
JG is a consultant/advisor and has received research grants from
Abbvie, Bristol-Myers Squibb, Gilead Sciences and Merck Co.,
Inc. GD is a consultant/advisor and has received research grants
from Abbvie, Bristol-Myers Squibb, Gilead Sciences, Merck Co., Inc,
Janssen Biotech and Roche. PB is consultant/advisor and has
Editorial / International Journal of Drug Policy 26 (2015) 893–898
received research grants from Abbvie, Bristol-Myers Squibb, Gilead
Sciences, Janssen Biotech and Merck Co., Inc.
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Jason Grebelya,f,*
Philip Bruggmannb
Carla Treloarc
Jude Byrned
Tim Rhodese
Gregory J. Dorea
on behalf of the International Network for Hepatitis in Substance
Users
a
The Kirby Institute, UNSW Australia, Sydney, Australia
b
Arud Centres for Addiction Medicine, Zurich, Switzerland
c
Centre for Social Research in Health, UNSW Australia, Sydney,
Australia
d
International Network of People Who Use Drugs, Canberra, Australia
e
Centre for Research on Drugs and Health Behaviour, London School of
Hygiene and Tropical Medicine, London, United Kingdom
f
Australian Injecting and Illicit Drug Users League, Canberra, Australia
*Corresponding
author at: Viral Hepatitis Clinical Research
Program, The Kirby Institute, UNSW Australia, Australia.
Tel.: +61 2 9385 0957; fax: +61 2 9385 0876
E-mail address: [email protected] (J. Grebely).