Offering HCV treatment to prisoners is an important opportunity: key principles based on policy and practice assessment in Europe

Chronic hepatitis C virus (HCV) infection is prevalent in people with a history of injecting drugs [1–3] – many of these people have a history of opioid use disorder (OUD) [4]. Individuals with OUD and a history of injecting drugs are often marginalized [4, 5] and face social [6], economic [7] and health problems [8]; many are underserved for healthcare with reduced access to services in the community [2, 9]. Involvement with criminal behaviour and imprisonment often becomes part of the career of people with OUD [10, 11]. Prisoners may be more likely to engage in a range of risk behaviour related to transmission of HCV and other blood borne-viruses [12, 13]. Harm reduction services, such as prison-based needle and syringe programs (PNSPs) and treatment for OUD, are important in reducing HCV prison incidence [14], and improving overall health outcomes [13]. In Spain, some prisoners have access to PNSP, but coverage remains limited in other European countries [14].

In Europe, prevalence of HCV infection in prison populations is estimated at 15% [15]. HCV treatment regimens based on direct-acting antiviral (DAA) medicines have improved efficacy, safety and tolerability profiles compared to historical interferon-based regimens [16]. Twelve DAA medicines have received European regulatory approval since 2011; access to safe and effective treatment has gradually improved for different groups [17]. Despite progress many prisoners still do not receive adequate assessment and opportunity for HCV treatment [16, 18]. Historically, many prisoners may not have engaged with HCV services due to a lack of understanding of new treatment options and concerns about the limited chance of successfully accessing treatment [19]. Organisation and infrastructure can make treatment difficult with delays associated with screening, workup and referral for treatment [19]. Access to specialists able to prescribe DAA often limits treatment. Prisoners with sentences less than 6 months may not be considered despite the shorter treatment duration of 2–3 months as a result of limited continuity of care options on release [20].

To date prisoner HCV treatment is limited in many countries in Europe; access to care is highly variable and often limited in prisons in Germany, Italy, France and England. Policy and clinical practice alignment has resulted in HCV treatment of prisoners in certain regions of Spain: national prison service, 2361 [21]; Catalunya, 529 [22]; Valencia 379 [23]. In these countries there are examples of individual prisons or regions where prisoner HCV treatment has been successful; it is observed that HCV treatment is not uniformly and easily available to all prisoners. Limited access to HCV care for prisoners is a missed opportunity as prison represents a point of care for citizens, in some cases, otherwise out of contact with conventional healthcare services.

Policy and effective implementation is a key determinant of the day to day practice in prisoner HCV care. Analysis and comparison of HCV treatment population sizes in prisons and policy determinants of clinical practice can inform the development of principles for improving prisoner HCV care in Europe.

A structured approach to assess the size of prison populations requiring HCV treatment in selected EU countries (England, France, Germany, Italy, Spain) was followed. Evidence describing the size and HCV prevalence of prison populations was identified in a search of published literature from 2007 to 2017 in the PubMed database. Search terms included: “hepatitis C”, “HCV”, “prisons”, “prisoners”, “prevalence”. Search returned 357 results, 343 were excluded because they did not meet the selection criteria (204 not in relevant countries of study focus, 121 not focused on assessing HCV prevalence, 14 not in prison population, 4 with no abstract available). The 14 sources from search were combined with 14 additional sources from relevant national or international agencies (England 2, France 2, Germany 2, Italy 3, Spain 5). These additional sources were identified by the authors, local experts with extensive relevant experience in prisoner healthcare in each country. Risk of bias was assessed by a previously existing tool for prevalence studies review [24]; results summarized in Appendix. To manage potential bias studies conducted in a small number of prisoners or in limited number of prisons at regional not national level, or limited by lack of randomization in sampling were compared to other evidence and a consensus from authors expert in local prisoner healthcare, agreed. The size of the prison population potentially requiring HCV care was synthesised based on population size and HCV prevalence evidence.

Mapping of prisoner HCV policy and practice guidance was completed using a common approach for selected countries. Evidence was identified in a standard review of sources. Sources included the publications of relevant government departments (including health and justice) describing evidence of policy or guidance for clinical practice for prisoners or HCV-related healthcare. Responsibility and governance for prisoner HCV care was identified and recorded from these sources. Policy assessments were based on the review of sources which described: (1) relevant law defining the principle of equivalence of access to healthcare for prisoners, (2) implications of existing national HCV care plans including guidance specifically in relation to any recommendation on practice in prisons or importance of prisoner care, (3) components of national prison strategy related to prisoner HCV diagnosis and management and also (4) clinical practice guidelines specific to HCV care in prison. Data from all sources were extracted and assessed by two reviewers familiar with comparative analysis and the therapy area. A consensus on important principles for policy and practice development was developed based on the results of the analysis.

Advances in HCV treatment and increasing access in the community setting to HCV care have led to a step change in treatment and outcomes; many prisoners do access HCV care. Treatment of HCV for prisoners is limited in Germany, increasing but limited in some areas in England, France, and Italy. In Spain there is wider access to care with still further progress needed.

Analysis of prison populations in 5 selected countries in Europe identifies 35,000 (25–45,000) prisoners potentially requiring HCV treatment. In each country estimated prisoner HCV populations identified are England and Wales, 9000 (range: 5–13,000), France, 8000 (4–12,000), Spain, 6000 (6–8000), Italy, 6000 (3–6000), Germany, 6000 (6–8000). Evidence describing prisoner HCV population is often limited and varying data is reported. Number of patients requiring treatment in this work is estimated based on an interpretation of the available studies and experience of experts actively engaged in the treatment system for each respective country. The number is an estimate based on best available sources and it is reasonable to assume from assessing evidence from published sources identified here. The range of population size is stated based on available sources; in each case the most likely value for a country was determined by final expert decision. Experts have extensive experience in prison healthcare and the evidence of appropriate population size.

There is important opportunity to improve outcomes for this group for whom access to care can be limited. Policy development and implementation of optimal clinical practice with improved engagement is key for success (e.g. providing education alongside streamlined, efficient screening programs using modern tools to reduce inconvenience and provide essential diagnostic information without excess delay). Sentence or custody length may present a barrier for prisoner assessment and inclusion in HCV care programs, which can be addressed. Policy and clinical guidelines should ensure that there is equity of selection for prisoners and that sentence length is not used inappropriately to limit treatment. In addition, optimizing treatment process to reduce time and facilitate treatment continuity can make treatment a reality for another 15,000 prisoners with short periods of custody. The right to prescribe modern DAA therapy should be as wide as possible to address access to specialists. Learning from the approach to HIV medicines prescribing is important – non-physician prescribing should be considered where locally possible including models of oversight to enable other HCP to commence therapy.

Successful treatment of HCV in the prisons is based on clear policy defining equity of access, linked to an integrated treatment approach, which directly addresses potential barriers to success. In locations where policy and treatment approach are aligned and optimal, many prisoners with HCV have been treated and prison acts as an important contact point for HCV care engagement.

Providing a treatment service in prisons consistent with these principles defines a gold standard. In this analysis no prisoner with HCV across any one country achieves full access to HCV care in prisons. Based on observations, it is noted that care is very limited in many areas in Germany, sometimes limited but increasing with areas of success in some areas in Italy, France and England and more commonly available in regions of Spain. All prisoner health services should aim to reach the gold standard of HCV care.

This work is based on an assessment of current approaches to prisoner HCV care from 5 countries in Europe. It is likely that these observations are applicable elsewhere: further work to assess the situation in other locations is recommended. Additional input from prison health, OUD and HCV specialists from other countries can add further to the understanding; many of the challenges and successes identified here may apply generally. Consensus on the size of relevant populations is reached based on the available evidence and expert familiarity with the treatment area. It is likely that the consensus represents a strong estimate of population size but this approach is limited - further measurement of prevalence of HCV in prisons should be undertaken in all settings to confirm the validity or improve this approach.

Periods of custody in prison are an opportunity for people underserved for healthcare to engage with services and to provide diagnosis, workup and treatment for HCV. Many do not receive HCV assessments and treatment in prison despite their needs. This qualitative analysis shows there is an opportunity to clarify relevant policy, develop specific guidance and support day-to-day clinical practice in prisons to improve care and use this opportunity. It is important to broaden access, make screening and treatment easier to improve outcomes for prisoner HCV care in many countries in Europe. This is a key part of the challenge to treat all persons whether in prison or the community with HCV. Further work to update policy and improve access and clinical practice should follow to realise this significant opportunity.