Correction: Monitoring progress towards elimination of hepatitis B and C in the EU/EEA.

[This corrects the article DOI: 10.1371/journal.pgph.0000841.].

Monitoring progress towards elimination of hepatitis B and C in the EU/EEA.

This paper presents data on selected indicators to show progress towards elimination goals and targets for hepatitis B and hepatitis C in the 31 countries of the European Union (EU) and European Economic Area (EEA). A monitoring system was developed by the European Centre for Disease Prevention and Control, which combined newly collected data from EU/EEA countries along with relevant data from existing sources. Data for 2017 were collected from the EU/EEA countries via an online survey. All countries provided responses. In 2017, most countries reporting data had not reached prevention targets for childhood hepatitis B vaccination and for harm reduction services targeting people who inject drugs (PWID). Four of 12 countries had met the target for proportion of people living with chronic HBV diagnosed and seven of 16 met this target for hepatitis C. Data on diagnosed cases treated were lacking for hepatitis B. Of 12 countries reporting treatment data for hepatitis B, only Iceland met the target. This first collection of data across the EU/EEA highlighted major issues with data completeness and quality and in the indicators that were used, which impairs a clear overview of progress towards the elimination of hepatitis. The available data, whilst incomplete, suggest that as of 2017, the majority of the EU/EEA countries were far from meeting most of the 2020 targets, in particular those relating to harm reduction and diagnosis. It is critical to improve the data collected in order to develop more effective services for hepatitis prevention, diagnosis, and treatment that are needed in order to meet the 2030 elimination targets.

A Feasibility Study to Increase Chronic Hepatitis C Virus RNA Testing and Linkage to Care among Clients Attending Homeless Services in Amsterdam, The Netherlands.

People who inject drugs (PWID) are disproportionately affected by hepatitis C virus (HCV) infections and are frequently homeless. To improve HCV case finding in these individuals, we examined the feasibility of rapid HCV RNA testing in homeless services in Amsterdam. In 2020, we provided a comprehensive service to homeless facilities, which included workshops on HCV for personnel, a "hepatitis ambassador" at each facility, a rapid, onsite HCV RNA fingerstick test service, and assistance with linkage to care. Risk factors for HCV RNA-positive status were examined using Bayesian logistic regression. Of the 152 participants enrolled, 150 (87% men; median age: 47 years) accepted rapid HCV testing. Seven tested HCV RNA positive (4.7%, 95%CrI = 1.31-8.09; 7/150). Of these, five (71%) were linked to care, of whom four (57%, 4/7) initiated treatment and one (14%, 1/7) delayed treatment due to a drug-drug interaction. Of these four people, two completed treatment (50%), of whom one (25%) achieved sustained virologic response after 12 weeks. HCV RNA-positive individuals were more likely to originate from Eastern Europe (posterior-odds ratio (OR) = 3.59 (95% credible interval (CrI) = 1.27-10.04)) and to inject drugs (ever: posterior-OR = 3.89 (95% CrI = 1.37-11.09); recent: posterior-OR = 3.94 (95% CrI = 1.29-11.71)). We identified HCV RNA-positive individuals and linkage to care was relatively high. Screening in homeless services with rapid testing is feasible and could improve HCV case finding for PWID who do not regularly attend primary care or other harm reduction services for people who use drugs.

Civil society involvement in harm reduction drug policy: reflections on the past, expectations for the future.

BACKGROUND: A range of civil society organisations (CSOs) such as drug user groups, non-governmental/third sector organisations and networks of existing organisations, seek to shape the development of drugs policy at national and international levels. However, their capacity to do so is shaped by the contexts in which they operate nationally and internationally. The aim of this paper is to explore the lived experience of civil society participation in these contexts, both from the perspective of CSOs engaged in harm reduction advocacy, and the institutions they engage with, in order to inform future policy development. METHODS: This paper is based on the presentations and discussions from a workshop on 'Civil Society Involvement in Drug Policy hosted by the Correlation - European Harm Reduction Network at the International Society for the Study of Drugs Policy (ISSDP) annual conference in Paris, 2019. In the aftermath of the workshop, the authors analysed the papers and discussions and identified the key themes arising to inform CSI in developing future harm reduction policy and practice. RESULTS: Civil society involvement (CSI) in policy decision-making and implementation is acknowledged as an important benefit to representative democracy. Yet, the accounts of CSOs demonstrate the challenges they experience in seeking to shape the contested field of drug policy. Negotiating the complex workings of political institutions, often in adversarial and heavily bureaucratic environments, proved difficult. Nonetheless, an increase in structures which formalised and resourced CSI enabled more meaningful participation at different levels and at different stages of policy making. CONCLUSIONS: Civil society spaces are colonised by a broad range of civil society actors lobbying from different ideological standpoints including those advocating for a 'drug free world' and those advocating for harm reduction. In these competitive arena, it may be difficult for harm reduction orientated CSOs to influence the policy process. However, the current COVID-19 public health crisis clearly demonstrates the benefits of partnership between CSOs and political institutions to address the harm reduction needs of people who use drugs. The lessons drawn from our workshop serve to inform all partners on this pathway.

Harm reduction in Europe: a framework for civil society-led monitoring.

BACKGROUND: Civil society organisations (CSOs) play a vital role in developing and implementing effective measures to reduce the harms of drug use. They are also fundamental actors to monitor and evaluate programmes and policies for improvement. While harm reduction services are subject to monitoring, and international and European indicators exist, a framework for civil society-led monitoring does not exist. This paper analyses the challenges and added values of developing such a framework for the European region. METHODS: Since 2018, a technical working group within Correlation-European Harm Reduction Network (C-EHRN) is developing and revising a monitoring framework, collecting-through National Focal Points-the experience of harm reduction service providers and service users in 34 European countries. The first round of data collection, in 2019, focused on hepatitis C, overdose prevention, new drug trends and civil society involvement in drug policies. RESULTS: Developing CSO-based harm reduction monitoring is a learning by doing process. Assuring reliability and national representativeness of the data was a central challenge. As most CSOs have little or no experience with monitoring and research and work in a local-based context, the monitoring approach and its indicators were adjusted to the local context in the second round, bringing more in-depth information and helping to improve results' reliability. While this implied shifting from the initial focus on comparing responses at a national level, the change to collecting qualitative data reflecting local realities of service policies and delivery provides the foundations for a critical appraisal of these realities against European policy goals. This allowed to map discrepancies between official policies and their implementation, as well as identify gaps in and complement data collection from national-level agencies. CONCLUSIONS: By focusing on local experiences regarding the delivery of global and European policy targets, C-EHRN monitoring uses the unique strengths of its CSOs network and generates information that complements the reporting by other monitoring agencies. Data reflecting the CSOs perspective is essential for optimising local planning of service provision and development of effective and respectful drug policies at national and European level. If data quality issues, as well as the sustainability of reporting, are adequately addressed, civil society monitoring can provide excellent added value for the monitoring of harm reduction in Europe.

Implementation and evaluation of an educational intervention for safer injection in people who inject drugs in Europe: a multi-country mixed-methods study.

BACKGROUND: Harm reduction (HR) interventions are essential to reduce human immunodeficiency virus (HIV) and hepatitis C virus (HCV) transmission in people who inject drugs (PWID). Preliminary testing of the Individually Tailored Support and Education for Safer Injection (ITSESI) evidence-based educational intervention for PWID was performed in France in 2011. We created the Eurosider project to implement and evaluate ITSESI at a wider European level, with a view to its future pan-European diffusion. METHODS: We performed a mixed-methods study involving quantitative (a 6-month before-after study with PWID) and qualitative (focus groups with field workers) components. The study was conducted in 2018-2019 with 307 eligible PWID participating in four existing HR programmes in Bulgaria, Greece, Portugal, and Romania. ITSESI consists in trained field workers observing PWID injection practices and providing an educational exchange. For the present study, PWID participants were allocated to either the control group (i.e., they continued receiving only the current HR services) or the intervention group (i.e., current HR services plus ITSESI). We used the RE-AIM QuEST framework to assess the effectiveness of ITSESI and its acceptability by field workers. Effectiveness was defined as a reduction in both syringe sharing - the highest HIV/HCV transmission risk practice - and in cutaneous abscesses. We used a multivariable mixed logit model to analyse both effectiveness outcomes and to provide adjusted odds ratios (aOR) and 95% confidence intervals (CI). Field workers' acceptability of the intervention was described using a thematic analysis of the qualitative data. RESULTS: Of the 307 PWID, 55% received ITSESI. Syringe sharing and cutaneous abscesses decreased during follow-up in the intervention group (from 25 to 16% and from 27 to 14%, respectively). Reductions were smaller in the control group (from 29 to 24% and from 23 to 18%, respectively). The multivariable analyses confirmed the effect of the intervention on both of these outcomes (aOR [95% CI]: 0.38 [0.17, 0.85]) and (aOR [95% CI]: 0.38 [0.16, 0.90], respectively). Our qualitative data on acceptability showed the feasibility of involving field workers as proactive research partners in making ITSESI more accessible and acceptable across Europe. CONCLUSIONS: We demonstrated both the effectiveness of ITSESI in reducing syringe sharing and cutaneous abscesses in four European countries, and a high level of intervention acceptability by field workers. Our findings provide important insights into how ITSESI can be adapted for pan-European implementation.

Beyond clinical outcomes: the social and healthcare system implications of hepatitis C treatment.

BACKGROUND: Hepatitis C virus (HCV) infections in people who inject drugs (PWID) can now be treated and cured. However, the impact that HCV treatment has on drug-user health, practices and wellbeing is not known. The aim of this research was to understand the non-clinical impact that HCV treatment has in PWID and their reasons for accessing and completing treatment. METHODS: Participants aged 25-67 years who had injected opioids or stimulants (currently or in the past) and had completed direct-acting antiviral treatment were recruited from seven European countries. Participants completed a 30-min online survey administered face-to-face between September 2018 and April 2019. The questionnaire responses were used to assess the mental and physical impact of having completed treatment. RESULTS: Of the 124 participants who completed the survey questionnaire, 75% were male, 69% were over 45 years old and 65% were using opioids and/or stimulants at the start of HCV treatment. Participants reported improvements in the following areas after completing HCV treatment: outlook for the future (79%); self-esteem (73%); ability to plan for the future (69%); belief in their abilities (68%); confidence (67%); empowerment (62%); energy levels (59%); and ability to look after themselves (58%). The most common reasons for starting HCV treatment were: becoming aware of treatments that were well tolerated (77%) and effective (75%); and understanding the potentially severe consequences of HCV (75%). CONCLUSIONS: The benefits of HCV treatment go beyond clinical outcomes and are linked to improved drug-user health and wellbeing. Sharing information about well-tolerated and effective HCV treatments, and raising awareness about the potentially severe consequences of untreated HCV are likely to increase the number of PWID who are motivated to access and complete HCV treatment in future.

Novel health systems service design checklist to improve healthcare access for marginalised, underserved communities in Europe.

BACKGROUND: Marginalised communities such as homeless people, people who use drugs (PWUD), lesbian, gay, bisexual, transgender and intersex people (LGBTI), prisoners, sex workers and undocumented migrants are at high risk of poor health and yet face substantial barriers in accessing health and support services. The Nobody Left Outside (NLO) Service Design Checklist aims to promote a collaborative, evidence-based approach to service design and monitoring based on equity, non-discrimination and community engagement. METHODS: The Checklist was a collaborative project involving nine community advocacy organisations, with a focus on homeless people, PWUD, LGBTI people, prisoners, sex workers, and undocumented migrants. The Checklist was devised via a literature review; two NLO platform meetings; a multistakeholder policy workshop and an associated published concept paper; two conference presentations; and stakeholder consultation via a European Commission-led Thematic Network (including webinar). RESULTS: The NLO Checklist has six sections in line with the WHO Health Systems Framework. These are: (1) service delivery, comprising design stage (6 items), services provided (2 items), accessibility and adaptation (16 items), peer support (2 items); (2) health workforce (12 items); (3) health information systems (7 items); (4) medical products and technologies (1 item); (5) financing (3 items); and (6) leadership and governance (7 items). It promotes the implementation of integrated (colocated or linked) healthcare services that are community based and people centred. These should provide a continuum of needs-based health promotion, disease prevention, diagnosis, treatment and management, together with housing, legal and social support services, in alignment with the goals of universal health coverage and the WHO frameworks on integrated, people-centred healthcare. CONCLUSIONS: The Checklist is offered as a practical tool to help overcome inequalities in access to health and support services. Policymakers, public health bodies, healthcare authorities, practitioner bodies, peer support workers and non-governmental organisations can use it when developing, updating or monitoring services for target groups. It may also assist civil society in wider advocacy efforts to improve access for underserved communities.

Securing sustainable funding for viral hepatitis elimination plans.

The majority of people infected with chronic hepatitis C virus (HCV) in the European Union (EU) remain undiagnosed and untreated. During recent years, immigration to EU has further increased HCV prevalence. It has been estimated that, out of the 4.2 million adults affected by HCV infection in the 31 EU/ European Economic Area (EEA) countries, as many as 580 000 are migrants. Additionally, HCV is highly prevalent and under addressed in Eastern Europe. In 2013, the introduction of highly effective treatments for HCV with direct-acting antivirals created an unprecedented opportunity to cure almost all patients, reduce HCV transmission and eliminate the disease. However, in many settings, HCV elimination poses a serious challenge for countries' health spending. On 6 June 2018, the Hepatitis B and C Public Policy Association held the 2nd EU HCV Policy summit. It was emphasized that key stakeholders should work collaboratively since only a few countries in the EU are on track to achieve HCV elimination by 2030. In particular, more effort is needed for universal screening. The micro-elimination approach in specific populations is less complex and less costly than country-wide elimination programmes and is an important first step in many settings. Preliminary data suggest that implementation of the World Health Organization (WHO) Global Health Sector Strategy on Viral Hepatitis can be cost saving. However, innovative financing mechanisms are needed to raise funds upfront for scaling up screening, treatment and harm reduction interventions that can lead to HCV elimination by 2030, the stated goal of the WHO.

Changes to the national strategies, plans and guidelines for the treatment of hepatitis C in people who inject drugs between 2013 and 2016: a cross-sectional survey of 34 European countries.

BACKGROUND: Hepatitis C virus (HCV) infection is the leading cause of cirrhosis, end-stage liver disease and hepatocellular carcinoma (HCC) worldwide. In Europe, people who inject drugs (PWID) represent the majority of HCV infections, but are often excluded from treatment. The aim of this study was to report on national HCV strategies, action plans and guidelines in European countries that include HCV treatment for the general population as well as for PWID. Data on access to direct-acting antivirals (DAAs) were also collected. METHODS: In 2016, 38 non-governmental organisations, universities and public health institutions that work with PWID in 34 European countries were invited to complete a 16-item online survey about current national HCV treatment policies and guidelines. Data from 2016 were compared to those from 2013 for 33 European countries, and time trends are presented. Differences in the data were analysed. Data from 2016 on general access to DAAs in PWID are presented separately. RESULTS: The response rate was 100%. Fourteen countries (42%) reported having a national HCV strategy covering HCV treatment; 12 of these addressed HCV treatment for PWID. Respondents from ten countries (29%) reported having a national HCV action plan. PWID were specifically included in seven of them. Twenty-nine countries (85%) reported having national HCV treatment guidelines. PWID were specifically included in 23 (79%) of them. Compared to 2013, respondents reported that an additional seven countries (25%) had national strategies, an additional eight countries (29%) had action plans and an additional six countries (19%) had HCV treatment guidelines. However, PWID were not included in two, four and six of those countries, respectively. DAAs were reported to be available in 91% of the study countries, with restrictions reported in 71% of them. CONCLUSION: Respondents reported that fewer than half of the European countries in this study had a national HCV strategy and/or action plan, with even fewer including PWID. However, when compared to 2013, the number of such countries had slightly increased. Although PWID are often addressed in clinical guidelines, strategic action is needed to increase access to HCV treatment for this group and the situation should be regularly monitored.

Hepatitis C services at harm reduction centres in the European Union: a 28-country survey.

BACKGROUND: In the context of the WHO's 2016 Viral Hepatitis Strategy and the introduction of treatment that can cure more than 95% of cases with hepatitis C virus (HCV) infection, the European Joint Action on HIV and Co-infection Prevention and Harm Reduction (HA-REACT) undertook a study in the member states of the European Union (EU). It aimed to determine service providers' understanding of the current services in their respective countries and the barriers experienced by PWID in accessing HCV testing, care and treatment services in their country. METHODS: In 2017, 38 purposively selected harm reduction service providers completed a 26-item English-language online survey addressing the availability, accessibility and funding of HCV services at harm reduction centres. HCV-related data and reported findings were extracted by country or by responding organization. RESULTS: Responses were received from all EU member states. Respondents from 23 countries reported that HCV tests are offered by harm reduction services in their countries, and eight countries reported that addiction specialists in their countries are able to prescribe HCV therapy. Almost half of the respondents (45%) said that their respective organizations had established referral systems with centres providing HCV treatment. CONCLUSIONS: Not all EU member states have harm reduction services that provide HCV tests, and many do not have established referral systems with treatment providers. Moreover, the inability of addiction specialists to prescribe HCV treatment points to missed opportunities to make treatment more accessible. Further, discrepancies were noted between the available HCV services and stakeholders' knowledge about their availability.

Drug consumption rooms (DCRs) as a setting to address hepatitis C - findings from an international online survey.

BACKGROUND: Prevalence of Hepatitis C Virus (HCV) among people who inject drugs (PWID) is high. Risky injecting behaviours have been found to decrease in drug consumption rooms (DCRs) and supervised injecting facilities (SIFs), yet HCV prevention and treatment in these settings have not been extensively explored. METHODS: To determine the range and scope of HCV prevention and treatment options in these services, we assessed DCR/SIF operational features, their clients' characteristics and the HCV-related services they provide. A comprehensive online survey was sent to the managers of the 91 DCRs/SIFs that were operating globally as of September 2016. A descriptive cross-country analysis of the main DCR/SIF characteristics was conducted and bivariate logistic models were used to assess factors associated with enhanced HCV service provision. RESULTS: Forty-nine valid responses were retrieved from DCRs/SIFs in all countries where they were established at the time of the survey (Australia, Canada, Denmark, France, Germany, Luxembourg, Netherlands, Norway, Spain and Switzerland). Internationally, the operational capacities of DCRs/SIFs varied in terms of funding, location, size and staffing, but their clients all shared common features of vulnerability and marginalisation. Estimated HCV prevalence rates were around 60%. Among a range of health and social services and referrals to other programs, most DCRs/SIFs provided HCV testing onsite (65%) and/or offered liver monitoring or disease management (54%). HCV treatment onsite was offered or was planned to be offered by 21% of DCRs/SIFs. HCV testing onsite was associated with provision of other services addressing blood-borne diseases and HCV treatment was linked to the provision of OST. HCV disease management was associated with employing a nurse at a DCR/SIF and HCV treatment was associated with employing a medical doctor. CONCLUSIONS: DCRs/SIFs offer easy-to-access HCV-related services for PWID. The availability of onsite medical professionals and provision of support and education to non-medical staff are key to enhanced provision of HCV-related services in DCRs/SIFs. Funding and support for HCV treatment at the community level, via low-threshold services such as DCRs/SIFs, are worthy of action.

Late presentation of chronic viral hepatitis for medical care: a consensus definition.

INTRODUCTION: We present two consensus definitions of advanced and late stage liver disease being used as epidemiological tools. These definitions can be applied to assess the morbidity caused by liver diseases in different health care systems. We focus is on hepatitis B and C virus infections, because effective and well tolerated treatments for both of these infections have greatly improved our ability to successfully treat and prevent advanced and late stage disease, especially if diagnosed early. A consensus definition of late presentation with viral hepatitis is important to create a homogenous, easy-to-use reference for public health authorities in Europe and elsewhere to better assess the clinical situation on a population basis. METHODS: A working group including viral hepatitis experts from the European Association for the Study of the Liver, experts from the HIV in Europe Initiative, and relevant stakeholders including patient advocacy groups, health policy-makers, international health organisations and surveillance experts, met in 2014 and 2015 to develop a draft consensus definition of late presentation with viral hepatitis for medical care. This was refined through subsequent consultations among the group. RESULTS: Two definitions were agreed upon. Presentation with advanced liver disease caused by chronic viral hepatitis for medical care is defined as a patient with chronic hepatitis B and C and significant fibrosis (≥ F3 assessed by either APRI score > 1.5, FIB-4 > 3.25, Fibrotest > 0.59 or alternatively transient elastography (FibroScan) > 9.5 kPa or liver biopsy ≥ METAVIR stage F3) with no previous antiviral treatment. Late stage liver disease caused by chronic viral hepatitis is clinically defined by the presence of decompensated cirrhosis (at least one symptom of the following: jaundice, hepatic encephalopathy, clinically detectable ascites, variceal bleeding) and/or hepatocellular carcinoma. CONCLUSION: These consensus definitions will help to improve epidemiological understanding of viral hepatitis and possibly other liver diseases, as well as testing policies and strategies.

The Berlin Hepatitis C Manifesto: access to prevention, testing, treatment and care for people who use drugs.

The treatment of hepatitis C has entered a new era since the advent of curative pharmaceuticals. As policy, government and civil society assemble in response, there are still gaps to be addressed. The Manifesto on Hepatitis C and Drug Use, launched in Berlin during the Correlation Hepatitis C Initiative conference in October 2014, was formulated and endorsed by many key organizations in the hepatitis field. The Manifesto takes strides to pinpoint shortcomings in hepatitis action oriented towards the population most affected by the hepatitis C virus (HCV): active drug users. Despite a considerable amount of evidence that active drug users are disproportionately affected by HCV, barriers to care remain. Engagement with representatives of communities of people who inject drugs (PWID) is imperative in order to effectively create guidelines which reflect reality. Unfortunately, widespread systemic stigmatization and lack of trust between affected communities, decision-makers and healthcare professionals have reproduced this divide. The Berlin Manifesto has identified a disconnect between evidence and action which must be answered. In this roundtable discussion, experts from diverse parts of the hepatitis community have contributed their perspectives and experience on access to prevention, testing, and treatment for HCV in PWID. The authors discuss relevant topics such as realities of access to HCV treatment in the United Kingdom, interventions of a regional network of active drug users in Europe and lack of PWID involvement in government policy in Catalonia. Collectively they challenge the neglect of HCV in PWID by many decision-makers and health care professionals and promote a scale-up of integrated prevention and treatment strategies focusing on this population. The authors' conclusions aim to clarify the discourse on hepatitis in order to prevent disease, save lives and work towards eventual hepatitis elimination.

Are there national strategies, plans and guidelines for the treatment of hepatitis C in people who inject drugs? A survey of 33 European countries.

BACKGROUND: Hepatitis C virus (HCV) infection represents a major global health problem, which in high-income countries now mostly affects people who inject drugs (PWID). Many studies show that the treatment of HCV infection is as successful among PWID as among other populations and recently PWID have been included in the international guidelines for the treatment of HCV infection. The aim of this survey was to collect data from European countries on the existence of national strategies, action plans and clinical guidelines for HCV treatment in the general population and PWID in particular. METHODS: Thirty-three European countries were invited to participate. Data on available national strategies, action plans and guidelines for HCV treatment in general population and in PWID specifically were collected prospectively by means of a structured electronic questionnaire and analyzed accordingly. RESULTS: All of the 33 invited European countries participated in the survey. Twenty-two responses came from non-governmental organizations, six from public health institutions, four from university institutions and one was an independent consultant. Fourteen (42.4%) of the countries reported having a national strategy and/or national action plan for HCV treatment, from which ten of them also reported having a national strategy and/or national action plan for treatment of HCV infection in PWID. Nearly three-quarters reported having national HCV treatment guidelines. PWID were included in the majority (66.7%) of the guidelines. Fourteen (42.4%) countries reported having separate guidelines for the treatment of HCV infection in PWID. CONCLUSIONS: Given the high burden of HCV-related morbidity and mortality in PWID in Europe, the management of HCV infection should become a healthcare priority in all European countries, starting with developing or using already-existing national strategies, action plans and guidelines for this population.