Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs

doi:10.1016/j.drugpo.2017.05.019

International Journal of Drug Policy

Volume 47, September 2017, Pages 51-60

https://doi.org/10.1016/j.drugpo.2017.05.019 Get rights and content

Abstract

Globally, it is estimated that 71.1 million people have chronic hepatitis C virus (HCV) infection, including an estimated 7.5 million people who have recently injected drugs (PWID). There is an additional large, but unquantified, burden among those PWID who have ceased injecting. The incidence of HCV infection among current PWID also remains high in many settings. Morbidity and mortality due to liver disease among PWID with HCV infection continues to increase, despite the advent of well-tolerated, simple interferon-free direct-acting antiviral (DAA) HCV regimens with cure rates >95%. As a result of this important clinical breakthrough, there is potential to reverse the rising burden of advanced liver disease with increased treatment and strive for HCV elimination among PWID. Unfortunately, there are many gaps in knowledge that represent barriers to effective prevention and management of HCV among PWID. The Kirby Institute, UNSW Sydney and the International Network on Hepatitis in Substance Users (INHSU) established an expert round table panel to assess current research gaps and establish future research priorities for the prevention and management of HCV among PWID. This round table consisted of a one-day workshop held on 6 September, 2016, in Oslo, Norway, prior to the International Symposium on Hepatitis in Substance Users (INHSU 2016). International experts in drug and alcohol, infectious diseases, and hepatology were brought together to discuss the available scientific evidence, gaps in research, and develop research priorities. Topics for discussion included the epidemiology of injecting drug use, HCV, and HIV among PWID, HCV prevention, HCV testing, linkage to HCV care and treatment, DAA treatment for HCV infection, and reinfection following successful treatment. This paper highlights the outcomes of the roundtable discussion focused on future research priorities for enhancing HCV prevention, testing, linkage to care and DAA treatment for PWID as we strive for global elimination of HCV infection.

Introduction

Globally, it is estimated that 71.1 million people have chronic hepatitis C virus (HCV) infection (The Polaris Observatory, 2017), including an estimated 7.5 million people who have recently injected drugs (PWID) (Nelson et al., 2011). There is an additional large, but unquantified, burden among those PWID who have ceased injecting (Hajarizadeh, Grebely, & Dore, 2013; Nelson et al., 2011). The incidence of HCV infection among current PWID also remains high in many settings (Morris et al., 2017a; Page, Morris, Hahn, Maher, & Prins, 2013). Morbidity and mortality due to liver disease among PWID with HCV infection continues to increase (Hajarizadeh et al., 2013), despite the advent of well-tolerated, simple interferon-free direct-acting antiviral (DAA) HCV regimens with cure rates >95% (Dore & Feld, 2015). As a result of this important clinical breakthrough, there is potential to reverse the rising burden of advanced liver disease with increased treatment and strive for HCV elimination among PWID and those who have ceased injecting.

Unfortunately, there are many gaps in knowledge that represent barriers to effective prevention and management of HCV among PWID. The Kirby Institute, UNSW Sydney and the International Network of Hepatitis in Substance Users (INHSU) established an expert round table panel to assess current research gaps and establish future research priorities for the epidemiology, prevention, and management of HCV among PWID. This round table consisted of a one-day workshop held on 6 September, 2016, in Oslo, Norway, prior to the International Symposium on Hepatitis in Substance Users (INHSU 2016). International experts in drug and alcohol, infectious diseases, and hepatology were brought together to discuss the available scientific evidence, gaps in research, and develop research priorities. Topics for discussion included the epidemiology of injecting drug use, HCV, and HIV among PWID, HCV prevention, HCV testing, linkage to HCV care and treatment, DAA treatment for HCV infection, and reinfection following successful treatment.

Section snippets

Epidemiology of injecting drug use, HCV, and HIV among PWID

People with a history of injecting drug use include those who report injecting an illicit drug at least once in their life. This population includes people who have permanently ceased injecting; “current” or “recent” injectors (with definitions for “recent” varying in the literature from one month to one year); as well as people who may be considered “occasional” injectors (including people in treatment for drug use disorders, some may be receiving opioid substitution therapy (OST), who have

Prevention of primary HCV infection

HCV incidence remains high in many settings (Hagan, Pouget, Des Jarlais, & Lelutiu-Weinberger, 2008; Morris et al., 2017a, Page et al., 2013, Wiessing et al., 2014), particularly in the first several years of injecting (Hagan et al., 2008; Roy, Boudreau, & Boivin, 2009), and ongoing HCV transmission is a major issue among PWID, with variations globally.

There is no HCV vaccine, either currently or readily foreseeable. A mathematical model recently suggested that a partially effective vaccine,

HCV testing

Simple, tolerable, and effective DAA HCV therapies have eliminated interferon as a major barrier to HCV scale-up in PWID and dramatically simplified diagnostic and monitoring needs (Cohn, Roberts, Amorosa, Lemoine, & Hill, 2015). However, in order for these therapies to have an effect at a population level (Grebely & Dore, 2014), targeted interventions to enhance HCV testing, linkage to care, and treatment (“the HCV care cascade”) are needed.

Globally, HCV testing and diagnosis remains

Linkage to HCV care and treatment

Linkage to HCV care and treatment also remains inadequate internationally (Bruggmann et al., 2014, Liakina et al., 2015, Saraswat et al., 2015). Simplified HCV testing, including dried blood spot testing (McAllister et al., 2014) and point-of-care HCV testing (Bottero et al., 2015, Morano et al., 2014) has been shown to facilitate linkage to HCV care. Other strategies that have been demonstrated to facilitate linkage to HCV care and treatment include, non-invasive liver disease screening using

DAA treatment for HCV infection

The availability of tolerable, highly effective all-oral DAA regimens has overcome the barrier posed by poor tolerability of interferon-based therapy, providing an important tool to achieve scale-up of HCV therapy in PWID.

Among people receiving OST with no recent illicit drug use, post-hoc analyses of phase II and III trials of DAA therapy have demonstrated that treatment completion, adherence, and sustained virological response (SVR) are similar to those not receiving OST (Dore et al., 2016,

Reinfection following successful treatment

Ongoing risk behaviours following successful HCV therapy and lack of adequate coverage of harm reduction interventions (e.g. NSP and OST) may lead to reinfection and compromised treatment outcomes (Cunningham, Applegate, Lloyd, Dore, & Grebely, 2015; Midgard et al., 2016). The incidence of HCV reinfection following successful interferon-based treatment among PWID ranges from 0.0 to 5.3/100 person-years (Aspinall et al., 2013, Cunningham et al., 2015, Midgard et al., 2016, Pineda et al., 2015;

Approach to these research priorities

A further consideration is the methods chosen to address these identified research priorities. This expert panel identified that a multi-disciplinary and multi-method approach is appropriate for these research priorities. In particular, the expertise and insight that can be drawn from social science and from direct involvement of the affected communities was highlighted as best and appropriate practice to optimise investment in HCV research.

Each of the research priorities posed across topics

Conclusion

The high burden of HCV infection among populations of PWID poses challenges for the implementation of evidence-based, best practice guidelines to shape the priorities that are identified for research. A key underpinning to research in each area of epidemiology, prevention, testing, linkage to care, treatment outcomes and reinfection is the prohibition that surrounds injecting drug use around the globe. Hence, a research question that is relevant to each area is the impact of policies and

Financial support

The Kirby Institute is funded by the Australian Government Department of Health. The National Drug and Alcohol Research Centre at UNSW Australia is supported by funding from the Australian Government under the Substance Misuse Prevention and Service Improvements Grant Fund. 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. LD is supported

Disclosures

JG is a consultant/advisor and has received research grants from Abbvie, Bristol Myers Squibb, Cepheid, Gilead Sciences and Merck. PB has served as advisor and speaker for, and has received project and research grants from AbbVie, BMS, Gilead, Merck, and Mundipharma. JVL is a consultant/advisor for Gilead Sciences and MSD and has received research grants from AbbVie and Gilead Sciences. MaHe received investigator initiated research grant support from Abbvie, Bristol Myers Squibb, and Gilead

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Hepatitis C treatment uptake among people who inject drugs in Oslo, Norway: A registry-based study
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Improving HCV treatment uptake among people who inject drugs (PWID) is crucial to achieving the WHO elimination targets. The aims were to evaluate HCV treatment uptake and HCV RNA prevalence in a large cohort of PWID in Norway.
Registry-based observational study where all users of the City of Oslo's low-threshold social and health services for PWID between 2010–2016 (n = 5330) were linked to HCV notifications (1990–2019) and dispensions of HCV treatment, opioid agonist treatment (OAT) and benzodiazepines (2004–2019). Cases were weighted to account for spontaneous HCV clearance. Treatment rates were calculated using person-time of observation, and factors associated with treatment uptake were analysed using logistic regression. HCV RNA prevalence was estimated among individuals alive by the end of 2019.
Among 2436 participants with chronic HCV infection (mean age 46.8 years, 30.7% female, 73.3% OAT), 1118 (45.9%) had received HCV treatment between 2010–2019 (88.7% DAA-based). Treatment rates increased from 1.4/100 PY (95% CI 1.1–1.8) in the pre-DAA period (2010–2013) to 3.5/100 PY (95% CI 3.0–4.0) in the early DAA period (2014–2016; fibrosis restrictions) and 18.4/100 PY (95% CI 17.2–19.7) in the late DAA period (2017–2019; no restrictions). Treatment rates for 2018 and 2019 exceeded a previously modelled elimination threshold of 50/1000 PWID. Treatment uptake was less likely among women (aOR 0.74; 95% CI 0.62–0.89) and those aged 40–49 years (aOR 0.74; 95% CI 0.56–0.97), and more likely among participants with current OAT (aOR 1.21; 95% CI 1.01–1.45). The estimated HCV RNA prevalence by the end of 2019 was 23.6% (95% CI 22.3–24.9).
Although HCV treatment uptake among PWID increased, strategies to improve treatment among women and individuals not engaged in OAT should be addressed.
“Stigma is where the harm comes from”: Exploring expectations and lived experiences of hepatitis C virus post-treatment trajectories among people who inject drugs
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Citation Excerpt :
Recent epidemiological evidence indicates that PWID have both a high degree of willingness to undergo DAA treatment and can be cured of HCV at rates comparable to other populations (>90%) (Alimohammadi, Holeksa, Thiam, Truong, & Conway, 2018; Mah et al., 2017; Socías et al., 2017). Accordingly, a growing body of social and implementation science research has identified priorities for action to scale up DAA treatments among PWID, including through healthcare reforms (e.g., removal of clinical and regulatory barriers to treatment; implementation of integrated, decentralized, and peer-led services) and broader socio-structural interventions to address high levels of poverty and the lack of affordable housing, as well as substance use-related criminalization and stigmatization (Day et al., 2019; Ford et al., 2015; Goodyear, Ti, Carrieri, Small, & Knight, 2020; Carla, Grebely, Bruneau, Bruggmann et al., 2017; Grebely, Bruneau, Lazarus et al., 2017; Knight & Ti, 2019). The evolving HCV care landscape signals a pivotal and long-awaited opportunity to reduce the inequitable burden (e.g., incidence, prevalence, impacts) of HCV among PWID.
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We thematically analyzed data from in-depth, semi-structured interviews, conducted between January and June 2018, in Vancouver, Canada, with a purposive sample (n = 50) of PWID at various stages of DAA treatment (e.g., pre, peri, post).
Our analysis yielded three themes. First, while participants had hoped to experience holistic enhancements in wellbeing following HCV cure, discussions of actual post-treatment experiences tended to be located in physical health (e.g., increased energy). Second, participants often pointed to the ways in which HCV-related and other stigmas had restricted opportunities for health and healthcare access. Participants therefore identified stigma-reduction as a key motivator of HCV cure, and while reductions in internalized stigma were sometimes achieved, participants underscored that other forms of enacted stigma (e.g., related to: substance use, HIV, poverty) had continued to feature prominently in their post-treatment lives. Third, participants described considerable knowledge about how to prevent HCV re-infection following cure, but they also expressed apprehensiveness about how socio-structural barriers, including stigma and criminalization, could interfere with harm reduction and re-infection prevention efforts.
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Citation Excerpt :
Furthermore, although it is acknowledged that regular post-treatment HCV RNA testing among PWID is a critical component of any elimination strategy (Grebely, Hajarizadeh, Lazarus, Bruneau & Treloar, 2019; Hajarizadeh et al., 2020; Midgard et al., 2016b), the feasibility of reinfection surveillance and retreatment has not been studied. There is therefore an unmet need for generalizable data on treatment outcomes and reinfection among more marginalized individuals with only brief contact with specialist health care (Grebely et al., 2017). This study aimed to evaluate DAA treatment effectiveness, reinfection rates, and associated factors in a real-world cohort of PWID attending an urban low-threshold HCV clinic.
The aims were to evaluate HCV treatment effectiveness, estimate reinfection rates, and demonstrate the feasibility of reinfection surveillance and retreatment among marginalized people who inject drugs (PWID).
Prospective observational study including consecutive HCV RNA positive individuals attending a low-threshold clinic in Oslo, Norway, between 2013 and 2020. Participants were offered individually tailored HCV treatment and post-treatment HCV RNA surveillance at three months intervals.
Of 488 HCV RNA positive individuals, 363 initiated treatment (median age 48.7 years, 72.5% male, 17.2% liver cirrhosis, 54.3% unstable housing). All participants had a history of injecting drug use, 71.1% received opioid agonist treatment, and 70.1% reported recent (past 3 months) injecting. In intention-to-treat analysis, excluding those with HCV RNA results pending, virologic response was achieved in 306 of 340 (90.0%) participants. In modified intention-to-treat analysis, also excluding those with loss to follow-up during treatment, virologic response was achieved in 306 of 323 (94.7%). Virologic response was not associated with recent injecting drug use or socio-demographic factors. Reinfection surveillance was accomplished in 297 individuals (308.2 PY of follow-up; median 0.50 years). Eight cases of reinfection were detected for an incidence of 2.60/100 PY (95% CI 1.12–5.11) overall, and 3.74/100 PY (95% CI 1.62–7.37) among those with injecting drug use during follow-up (n = 205). Reinfection was associated with younger age (IRR 0.37; 95% CI 0.18–0.74), and all cases occurred in participants aged below 49 years with ongoing injecting drug use who reported mixed heroin/amphetamine injecting. Successful retreatment was provided in all cases and no second reinfections were observed.
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2021, International Journal of Drug Policy
Citation Excerpt :
In Sweden, reasons for being LTFU has not been studied before, but a study found that WWID at NEP enrolment had higher injection risk behaviours compared to MWID, also reducing their injection risk behaviours faster and proportionally more (Kåberg et al., 2020). Optimization of policy-making and harm reduction programs including NEP should be based on continuously updated gender--specific evidence (Iversen, Page, Madden & Maher, 2015; Karlsson et al., 2017; Rehle, Lazzari, Dallabetta & Asamoah-Odei, 2004) and NEP performance, the lack of which has hindered development of comprehensive policy guidelines, especially targeting women's needs (Grebely et al., 2017; Iversen et al., 2015; Larney et al., 2015; Roberts et al., 2010). Consequently, the aim of this study was to analyze the NEP continuum of care from a gender--perspective i.e., to better understand WWID and MWID subgroup characteristics associated with injection- and sexual risk behaviour at NEP enrolment, being LTFU, and retention in the NEP.
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In an open prospective NEP cohort, 697 WWID and 2122 MWID were followed, 2013–2018. Self-reported socio/drug-related determinants for receptive injection (needle/syringe and paraphernalia) and sexual risk behaviours at enrolment, lost to follow-up (LTFU) and probability of retention, were assessed for both groups. Multivariable logistic regression (adjusted odds ratios, aOR) for enrolment and Poisson regression (adjusted incidence rate ratios, aIRR) for LTFU, were used. Cumulative NEP-retention probability was analysed using a six- and 12-month scenario.
At NEP enrolment, injection risk behaviours among WWID were associated with: younger age; homelessness; amphetamine-IDU; non-participation in opioid substitution therapy (OST); history of custody and among MWID: lower education level; cohabitation; homelessness, being a tenant; amphetamine-IDU; non-participation in OST; history of being sectioned, HIV-negative and HCV-positive. Condomless sex among WWID was associated with: younger age; lower education-level; cohabitation; having a partner; amphetamine-IDU; non-participation in OST; being HIV-negative and HCV-positive and among MWID: younger age; married; cohabitation; having a partner; amphetamine-IDU; non-participation in OST; history of custody, prison and being HIV-negative. WWID had higher NEP-retention levels compared to MWID over time. Being LTFU among WWID was associated with being HIV-negative and reporting injection risk behaviours and among MWID, younger age, non-participation in OST, being HIV-negative and having protected sex.
Despite better NEP compliance among WWID, high injection and sexual risk behaviours in both gender-subgroups, especially in intimate relationships, suggests ongoing HCV and HIV-infection risks. Subgroup-variation in the NEP continuum of care warrants more gender-disaggregated research and tailoring gender-sensitive services may improve prevention, health and retention outcomes.
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WHO has set global targets for the elimination of hepatitis B and hepatitis C as a public health threat by 2030. However, investment in elimination programmes remains low. To help drive political commitment and catalyse domestic and international financing, we have developed a global investment framework for the elimination of hepatitis B and hepatitis C. The global investment framework presented in this Health Policy paper outlines national and international activities that will enable reductions in hepatitis C incidence and mortality, and identifies potential sources of funding and tools to help countries build the economic case for investing in national elimination activities. The goal of this framework is to provide a way for countries, particularly those with minimal resources, to gain the substantial economic benefit and cost savings that come from investing in hepatitis C elimination.

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CommentaryResearch priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs

Abstract

Introduction

Section snippets

Epidemiology of injecting drug use, HCV, and HIV among PWID

Prevention of primary HCV infection

HCV testing

Linkage to HCV care and treatment

DAA treatment for HCV infection

Reinfection following successful treatment

Approach to these research priorities

Conclusion

Financial support

Disclosures

Recommendations for testing, managing, and treating hepatitis C

Hepatitis C testing in drug users using the dried blood spot test and the uptake of an innovative self-administered DBS test

Addictive Disorders & Their Treatment

Outcomes of treatment for hepatitis C virus infection by primary care providers

The New England Journal of Medicine

Treatment of hepatitis C virus infection among people who are actively injecting drugs: A systematic review and meta-analysis

Clinical Infectious Diseases

Does informing people who inject drugs of their hepatitis C status influence their injecting behaviour? Analysis of the Networks II study

International Journal of Drug Policy

A pilot study of rapid hepatitis C virus testing in the Rhode Island Department of Corrections

Journal of Public Health

Treatment with direct-acting antiviral agents of hepatitis C virus infection in injecting drug users: A prospective study

Journal of Viral Hepatitis

Simultaneous human immunodeficiency virus-hepatitis B-hepatitis C point-of-care tests improve outcomes in linkage-to-care: Results of a randomized control trial in persons without healthcare coverage

Open Forum Infectious Diseases

Effectiveness of DAA-based treatment of HCV in active people who inject drugs living in middle income countries (MIC): the results of a prospective cohort study in Tbilisi, Georgia

Journal of Hepatology

Discrimination by health care workers versus discrimination by others: Countervailing forces on HCV treatment intentions

Psychology, Health & Medicine

Historical epidemiology of hepatitis C virus (HCV) in selected countries

Journal of Viral Hepatitis

Models of care for the management of hepatitis C virus among people who inject drugs: One size does not fit all

Clinical Infectious Diseases

Nothing about us without us, greater, meaningful involvement of people who use illegal drugs: A public health, ethical, and human rights imperative

The effect of introducing point-of-care or dried blood spot analysis on the uptake of hepatitis C virus testing in high-risk populations: A systematic review of the literature

International Journal on Drug Policy

Simplified diagnostic monitoring for hepatitis C, in the new era of direct-acting antiviral treatment

Current Opinion in HIV and AIDS

Efficacy of all-oral HCV therapy in people who inject drugs

Hepatology

Improving blood-borne viral diagnosis; clinical audit of the uptake of dried blood spot testing offered by a substance misuse service

Journal of Viral Hepatitis

Hepatitis C infection among injecting drug users in general practice: A cluster randomised controlled trial of clinical guidelines’ implementation

British Journal of General Practice

Mixed HCV infection and reinfection in people who inject drugs—impact on therapy

Nature Reviews Gastroenterology & Hepatology

Experience of hepatitis C testing among injecting drug users in Sydney, Australia

AIDS Care

Hepatitis C virus treatment as prevention among injecting drug users: Who should we cure first?

Addiction

Estimating the burden of disease attributable to injecting drug use as a risk factor for HIV, hepatitis C, and hepatitis B: Findings from the Global Burden of Disease Study 2013

Lancet Infectious Diseases

Prevention of HIV infection for people who inject drugs: Why individual, structural, and combination approaches are needed

The Lancet

Global burden of HIV, viral hepatitis, and tuberculosis in prisoners and detainees

The Lancet

Elbasvir/grazoprevir to treat HCV infection in persons receiving opioid agonist therapy: A randomized controlled trial (C-EDGE CO-STAR)

Annals of Internal Medicine

Hepatitis C virus therapeutic development: In pursuit of perfectovir

Clinical Infectious Diseases

HCV reinfection and injecting risk behavior following elbasvir/grazoprevir treatment in patients on opioid agonist therapy: Co-STAR Three Year Follow-up Study

Hepatology

Elbasvir-grazoprevir to treat hepatitis c virus infection in persons receiving opioid agonist therapy: a randomized trial

Annals of Internal Medicine

Effectiveness of a risk screener in identifying hepatitis C virus in a primary care setting

American Journal of Public Health

Public health implications of rapid hepatitis C screening with an oral swab for community-based organizations serving high-risk populations

American Journal of Public Health

HCV Ag quantification as a one-step procedure in diagnosing chronic hepatitis C infection in Cameroon: the ANRS 12336 study

Journal of the International AIDS Society

EASL recommendations on treatment of hepatitis C 2016

Journal of Hepatology

A randomized controlled trial of an integrated care intervention to increase eligibility for chronic hepatitis C treatment

American Journal of Gastroenterology

Public health clinic-based hepatitis C testing and linkage to care in baltimore

Journal of Viral Hepatitis

Commentary
Research priorities to achieve universal access to hepatitis C prevention, management and direct-acting antiviral treatment among people who inject drugs

Evaluation of the Xpert^® HCV Viral Load point-of-care assay from venipuncture-collected and finger-stick capillary whole-blood samples: A prospective study