Monitoring hepatitis C virus infection treatment uptake among people who inject drugs in Europe

Transcription

1 Monitoring hepatitis C virus infection treatment uptake among people who inject drugs in Europe Draft report 11 th May 2012 TG Meeting participants

2 1. Introduction 3 2. HCV treatment meeting summary 3 3. Discussion and conclusions 7 Inform national policies 8 Provide guidance for practitioners 8 Collect data on HCV treatment uptake among PWID 8 APPENDIX 1 10

3 1. Introduction Despite advances in Hepatitis C virus (HCV) infection treatment and high prevalence of HCV infection among people who inject drugs (PWID), treatment uptake among this group constitutes a small proportion of those receiving HCV treatment, where data are available. To advance the discussion and begin to chart better our own work on this topic, EMCDDA held a one-day expert meeting (for final agenda, see Appendix 1). The meeting aimed at informing our conceptual framework in terms of monitoring HCV treatment uptake among PWID in Europe and putting together first steps of a pilot study of what we might do in this area within the next few years. 2. HCV treatment meeting summary Lucas Wiessing informed the audience of our own EMCDDA advancements in terms of monitoring HCV from an epidemiological point of view. His presentation reviewed European HCV antibody prevalence data, highlighting certain trends, both national and regional of Declining HCV antibody prevalence has been detected among PWID in six countries while an increase has been reported in Austria, Bulgaria, Cyprus, Greece and Romania. The presentation however alluded to the uncertainties around determining HCV prevalence among PWID as well as to estimating the number of drug injectors in different European countries. The presentation also looked at intervention [opioid substitution therapy (OST) and needle and syringe programmes (NSP)] coverage and relevant EMCDDA data were presented, including testing uptake also. Finally, some results of the modelling study on disease burden of HCV among PWID in the Amsterdam area were shown and the implications were discussed of two scenarios for treatment of HCV with or without HIV co-infection. In conclusions, it was highlighted that, based on current EMCDA data in the area of HCV, PWID are the largest risk group for HCV infection although considerable differences exist between countries. There is a need for improved epidemiological data and modelling to understand the extent of the problem. There is a need to establish the extent of HCV antiviral treatment uptake among PWID in Europe as there is currently no data on this indicator. Peter Vickerman and Natasha Martin of London School of Hygiene and Tropical Medicine and the School of Social and Community Medicine, University of Bristol emphasised again the evidence originating from England that involvement in 100 % NSP (defined as exchanging more syringes than one uses to inject) or OST reduce by 50 % the risk of infection and the combined effect of NSP and OST brings about 80 % decrease in the individual risk infection. In their talk, they used those recent UK data to consider whether scaling up the coverage of OST or high intensity (100 %) NSP (increase in the proportion of people exchanging more syringes than they inject) would reduce HCV prevalence; whether HCV antiviral therapy for PWID would reduce HCV prevalence and how does this impact compare to scaling up NSP/OST. Assuming current UK chronic HCV prevalence at 40 %, modelling the impact of scaling up OST and 100% NSP to 60, 70 and 80 % coverage reveals in the UK after 5, 10 or 20 years reveals that without NSP or OST the chronic prevalence could have been 65 %. Scaling up however of the coverage of thee interventions is unlikely to decrease HCV prevalence to <30 % and <25 % in 10 and 20 years respectively, unless coverage is increased by over half to 80 %. Providing HCV antiviral treatment to 40 per 1000 PWID may result in nearly a 60% reduction in prevalence, from 40% in 2012 to 17% by In terms of costeffectiveness, in places with 40% chronic infection even halving (instead of curing all HCV) sustained viral response (SVR) is cost effective. Once more, the need was highlighted for more and better data on coverage of interventions (NSP and OST), efficacy of OST and NSP for HCV incidence, current HCV antiviral treatment rates among PWID and HCV antiviral therapy efficacy among PWID. In conclusions, scaling up OST and 100 % NSP is likely to have an impact on HCV prevalence it is likely to take a long time to occur and it would require PWID to be retained on these interventions for longer. HCV treatment could have a greater impact (particularly in low and moderate prevalence areas). A combination interventions and a scale up of OST, NSP and HCV antiviral treatment would be an ideal strategy and is likely to be required to decrease HCV prevalence to low levels. Finally new medicines that are under development, in particular direct acting anti-viral medicines and interferon-free regimes could potentially substantially increase the impact of HCV treatment as prevention because of the higher SVR rates that can potentially increase the uptake of treatment among the population of PWID; the shorter treatment 3

4 duration could mean they there is greater treatment capacity and we could see higher adherence, willingness to treat and treatment completion rates among PWID because of fewer side effects particularly of the new treatments. The new treatments on the other hand are likely to be more expensive and produce resistance so it would be interesting to see how these new treatments will actually be used when treating current injectors. Jason Grebely of the Kirby Institute for Infection and immunity in society, University of New South Wales (UNSW) (Australia) presented some work (the CHASE study) that has been done in Canada. In a cohort of just under people in downtown Vancouver, health utilisation was assessed retrospectively and prospectively, relative to a survey of the cohort at a single point in time, using personal health numbers to link to health care services databases, including virology database, providing data on testing (HIV and HCV) performed in the community; pharmaceutical database, providing information on HCV therapy (interferon and ribavirin) provision; mortality database. In the XHASE cohort, 65 % were HCV antibody positive and, based on linkage to individual prescription data, 1 % had received HCV infection treatment and of those, 20 % achieved an SVR. The strengths of the linkage method include the unique linkages to virology laboratories statistics and HC treatment, and the provision of representative picture of health service utilisation and health outcomes. One of the major limitations of the study was that there was no systematic serological testing. The method and its feasibility could be explored and discussed as a potential approach to monitoring HCV treatment uptake in Europe. In another cohort of PWID in Vancouver, 16 % were reported to have received HCV treatment, with factors associated with decreased treatment uptake involving HIV infection (five times less likely) and injection heroin use in the past 30 days (three times less likely). Of those not having received treatment, 77 % were willing to receive treatment, with factors associated with willingness to receive HCV treatment including: having physical health problems (four times more likely), not being infected with HIV (four times more likely) and no injection drug use in past 30 days (four times more likely). Among the reasons (perceived barriers) for not seeking treatment among the HCV positive and untreated cases, were: lack of information, i.e., patients did not know that HCV treatment was available (23 %), absence of symptoms (20 %), perceived side effects of treatment (14 %), mild liver disease (10 %), other medical co-morbidities (8 %), lack of interest in treatment (3 %). The need of an educational component was highlighted in order to increase the uptake of HCV treatment among the population of PWID. Sharon Hutchinson of Health Protection Scotland addressed in her presentation the epidemiology of HCV and the public health policy response to it in Scotland. The prevalence of HCV among PWID is estimated at 55 %. The Scottish Government Hepatitis C Action Plan: a two phased response started in Phase one of the plan had gathered evidence that over a PWID require HCV treatment each year and a very small proportion (about 20 %) of those who were diagnosed had ever been in specialist care against a background of a rising burden of disease, with about people who had already developed cirrhosis. That evidence had given impetus to phase two of the Action Plan, in which the Scottish Government had invested significantly GBP 43 million for over three years to improve services across Scotland in terms of diagnosing, preventing and treating HCV infection. Focusing on the treatment and care side of the Action Plan, the major message had been that there were insufficient number of PWID who were in care and receiving HCV therapy and so the major action was around increasing the number of people that had been treated, with GBP 28 million put towards this particular Action. More specifically the investment was in developing multidisciplinary networks which guided the planning and delivery of services. The target was set at people going into HCV treatment each year by the end of the Action. A great emphasis was placed on monitoring performance the number of people who were commenced on HCV anti-viral therapy each year and the number that were achieving SVR. To perform the monitoring, a national HCV Clinical Database was set up, recording clinic attendance, demographic details, individual risk factors (ever injected drugs), treatments, liver disease, laboratory test results. At present, there are 80 HCV treatment clinics nationally (across Scotland), seven of which are in Glasgow, with an overall number of patients attending these clinics each year. Of those who were diagnosed HCV and initiated on HCV anti-viral therapy in 2010/11, 80 % were injecting drug users (among those with known drug risk). Among the group of people living with known chronic HCV and ever diagnosed in Scotland in 2010, 88 % were ever injectors (among those with known risk). Between 2008 and 2010, the number has nearly doubled of people initiated on HCV therapy and attending the HCV clinics in Scotland (2008: 591 people; 2010: people) representing 1.5 % and 2.7 % of the chronic HCV cases identified in 2008 and 2010 respectively. In the population of PWID, among the number of individuals that had ever being 4

5 diagnosed (17 500), the uptake of HCV treatment is around 6 %, and among the ever injectors at about 5.4 %. Maria Prins from Amsterdam Public Health Service described access to HCV testing, treatment and treatment outcome in the area of Amsterdam, as well as results from work conducted by her team on the effect of HCV on burden of disease. Within Dutch-C (Drug Users Treatment for Chronic Hepatitis C), since 2006, testing has been offered for HCV to all drug users in the Amsterdam cohort studies, and since 2007 to all drug users in Amsterdam. The test uptake among these to who testing was offered was at 90 %, with the following factors associated with acceptance to test: previous HCV treatment, methadone prescription, not being homeless. Sixty per cent tested anti- HCV positive, with chronicity rate of 69 %. The treatment uptake was overall at 16 %, and among the HCV monoinfected individuals 33 % (individuals who did not show any liver fibrosis at the time of biopsy were systematically advised to wait until the new HCV therapies were available, so the treatment uptake could have been higher if advice was more progressive to start HCV treatment even in cases of no present signs of liver fibrosis). Attendance to treatment clinics for methadone and injections of interferon was at 95 % (of all planned clinic visits). The positive treatment outcome was 65 % SVR, associated with G2,3, methadone use, and young age. In terms of re-infection among those achieving SVR, at four years follow-up, none of the three relapse cases was found to be a re-infection case. Mortality rates were also determined at the four-year follow up point, in a competing risk model, 80 % of the successfully treated were still alive. With regard to the effect of CV on the burden of disease, beyond treatment provision for HCV (in both HCV monoinfected and HIV coinfected individuals) to reduce HCV prevalence (as modelled by 2060), an important point is that in Amsterdam (akin to other parts of Europe), there is a declining epidemic of drug injecting therefore, the effect of HCV treatment on the burden of disease would be much higher compared to other scenarios (e.g. at the beginning of an epidemic or in a situation of stable epidemic). On a final note and considering the national situation, there is no national surveillance of HCV treatment uptake among PWID although there is a good national HIV database, including the possibility to extract data by risk group, and the database contains HCV treatment status information also. For HIV negative individuals, there is no national database, but there are thought about setting up a national monitoring database to capture the HCV treatment uptake although it is unsure whether information on risk factors will be included. Philip Bruggmann of ARUD, Switzerland gave an overview of HCV epidemiology, treatment paths and care for HCV infected PWID in Switzerland, including the monitoring situation in this country. There is about 75 % coverage of OST and comparable, if not higher, of NSP. About opioid dependent individuals are in heroin assisted treatment in Switzerland. In a final introductory note, the number of drug injectors, has been decreasing. About 50 % of drug users in treatment are under the care of GPs and the rest are in care in specialist addiction treatment centres. Some of the GPs providing OST, also provide HCV therapy to HCV infected clients, while others refer to hepatologists /gastroenterologists for HCV management. Currently, treatment indication for HCV is rather conservative and treatment can often be deferred if there is past history of drug injecting. Most of the specialist addiction units are led by psychiatrists and there is no application of an integrated care approach for the HIV/HCV infected drug clients. The integration of services that is introduced at the ARUD clinics is more the exception rather than the normal standard of addiction care and health care services provision in Switzerland. The Swiss cohort studies have collected data, including HCV treatment uptake data but exclusively on a secondary and tertiary level. One study in Switzerland provides data (these are the only data available) on HCV treatment uptake among PWID: among two national cohorts: HepC cohort: 38 %, HIV cohort: 24 %; and among patients in three OST clinics with integrates HCV care: 23 %; and finally, among one supervised injectable heroin (SIH) clinic without integrated HCV team: 8 %. Patients in SIH treatment were found to be three times more likely than OST patients to commence HCV treatment. The highest SVR rate was achieved in the HIS clinic: 63 % and the lowest in the OST clinics: 47 %. SVR rates in the national HepC and HIV cohorts averaged 50 %. In conclusions, there is an urgent need in Switzerland for consistent data on HCV treatment uptake among PWID; the national situation is heterogeneous: different pathways into HCV care organisation of HCV care provision for PWID. Also, the existing data is only from institutions with strong interest in HCV care for WID and finally, there are indicators for poor treatment uptake among OST patients. There are ongoing discussions with the health care authorities in Switzerland to develop and adopt an HCV Action Plan akin to that in Scotland. 5

6 Jason Grebely described in a second presentation showed survey data on HCV treatment uptake among PWID in Australia. The data (patient and practitioner) was gathered through online electronic data capture system. A cohort (n= 237) of OST clients with a history of drug injecting and an HCV assessment has been followed up within the ETHOS study (Enhancing HCV assessment in the OST setting). In another community treatment patient sample (n=634) (National Centre in HIV Social Research), the questionnaire was dropped off at the recruitment sites (OST clinics, NSP, pharmacies dispensing opioid medicines). The questions that were asked were: are you currently on peginterferon treatment for HCV or have you ever been on interferon or peginterferon treatment for HCV. Sixty-six per cent of the ETHOS sample have been referred to a specialist, of whom 44 % attended and a further 19 % initiated treatment. Looking at factors independently associated with HCV treatment, female were less likely to receive treatment, those who have injected in the previous six months were about two times less likely to have received treatment, individuals who were currently in OST were about five times less likely to have received HCV treatment, and those with more advanced liver disease were more likely to receive HCV treatment. Knowledge about HCV and also knowing someone who has died from HCV was associated with taking up treatment. Finally, the design and data were presented from the Australian NSP survey an annual cross-sectional survey, ongoing since 1998, developed strategically as an early warning system for monitoring blood-borne viruses in Australia (HIV, HCV, HBV antibody and the associated risk behaviours + dry bloodspot testing for HCV and HBV antibody testing). Patients self-complete a questionnaire asking Have you ever been in treatment for HCV? and If yes, are you on any HCV treatment now? Between 1998 and 2010, there were NSP survey participants with a self-reported diagnosis of HCV, of whom 6 % reported to have ever received HCV treatment. In terms of current HCV treatment, it is around 3 % (by self-report) for In conclusion, there is a variety of study designs that can be potentially used to look at HCV treatment uptake in PWID and studies can also provide useful information on barriers and facilitators to treatment uptake. Existing surveillance systems can be used to monitor HCV treatment uptake if specific questions were added. Matthew Hickman of University of Bristol talked about a project funded by the National Institute of Health Research (NIHR), England, looking at (i) HCV treatment among PWID and model projections and (ii) patients involvement (some of this work presented during the meeting by Tim Rhodes). Looking at the treatment uptake across participating sites for which data had been collected (n=6), despite different numbers of PWID engaging with the different drug clinics, looking at the HCV treatment uptake reveals that 14 people have been treated for HCV per injectors. To demonstrate the impact of treatment uptake in terms of changing HCV prevalence can be a challenge however. For England and Wales, the uncertainty spreads from anything between and anti-hcv positive individuals; there is further heterogeneity across different sites in a country. The sampling error in surveys could be between 10 % and 110 %, as demonstrated by Mills and colleagues (Drug & Alc Dep, in press). Another area of uncertainty is around the duration of people s injecting career, including the complication from having to account for the time to relapse (in addition to time from first injection to injecting cessation). The prevalence of injectors also varies between to (for England and Wales), and so does the estimation of problem drug users (based on exactly the same data) with little clue as to which one is right. So, if we are trying to measure the number of people who are treated per injector, this uncertainty needs to be also taken into account. This work is underway in the UK and potentially across some European countries that will enable us to say how far away we are from observable difference in relation to HCV prevalence, which can then be translated into HCV treatment scale up. Vratislav Rehak of the integrated drug treatment center Remedis, Prague (Czech Republic) shared data from a programme for comprehensive care for HCV infection among drug users (n=345) attending a singe drug treatment centre (Remedis). In introduction, the prevalence of HCV in the Czech Republic is estimated at < 0.2 % in the general population and at about 30 % among PWID. In the study cohort (HCV positive and treatment naïve), recruited between , HCV duration was reported at 3.8 years. 40 % were in receipt of OST upon commencing HCV treatment. SVR was reported at 81 % (G1(4)) and 84 % (Gnon-1). The factors, associated with SVR included: <40 years of age, early stages of fibrosis (no steatosis), compliance (in the context of comprehensive treatment for addiction and hepatitis). Approaching 90 % curability, it can be concluded that in certain settings, the treatment of HCV in drug users is possible. 6

7 Jens Reimer of Centre for Interdisciplinary Addiction Research presented data on the epidemiology of HCV nationally, with % HCV prevalence among OST clients and drug consumption room attendees, although there is variation across regions with regard to HCV prevalence among PWID. HCV treatment is covered by health insurances in Germany and everybody who has access to a health insurance would have access to treatment. HCV and OST are closely connected and there is hardly any HCV treatment for drug users who are not in OST. At present, the HCV treatment coverage is estimated at around 10 %, based on all HCV PCR positive OST patients. This can be considered an overestimation, however, because of likely selection bias. Possible data sources for HCV treatment in Germany were reviewed and discussed, including (i) OST/HCV treatment surveys (involving registered OST physicians) and (ii) Computing centres for pharmacies (that should however exclude private treatment provision). An estimation of HCV treatment uptake amongst OST patients in Hamburg has recently been obtained, using a combination of (i) individual prescription (OST and HCV medicines) data (from the Northern Computing Centre) and (ii) survey data. Using this approach in the area of Hamburg provides access to 50 % of the OST patient in this area. Tim Rhodes of LSHTM presented results from qualitative research funded by WHO and NIHR, exploring the social factors that could explain the low uptake of HCV treatment among PWID. Understanding treatment access includes understanding both individual drug injector factors and system-level factors that influence treatment decisions. The key feature of the framework in which the data are examined is that treatment access is not viewed as an individual problem (e.g. compliance, treatment expectations) but as a matter of social condition (e.g. system-level effects and structural factors). Based on 35 interviews (of whom 32 OST patients) with service users and service providers hepatologists, nurses, physicians, drug/alcohol service managers (n=14), a range of themes were explored including but not limited to treatment as part of a trajectory towards recovery, mistrust in the health care system, especially hospital settings, provider facilitated user engagement, eligibility and tailored intervention. There is potential for inclusion of qualitative research inside the broader monitoring discussion on HCV treatment uptake among PWID. Luís Mendão of the European AIDS Treatment Group put together all aspects of the topic discussed during the day and highlighted the need for developing indicator and the importance of a collaborative (EMCDDA-ECDC) endeavour for that. A number of priorities for action, from the point of view of civil society, were highlighted, including: (i) (ii) (iii) (iv) to pursue health education and improve treatment literacy among drug users; to make use of peers in promoting access to HCV treatment; to influence the industry to consider reduced medication costs; to collaborate with the pharmaceutical industry on improving HCV treatment, e.g., inclusion in clinical trials of stable PWID/PWUD. The EU agencies were called on to work together in informing policy makers about the need to treat; and the need for European guidance for delivering HCV treatment in drug treatment settings was highlighted also. The continuing interest and readiness were confirmed of civil society associations to support and contribute to the work of EMCDDA with regard to improving the information about the availability and provision of HCV treatment to PWID in Europe. 3. Discussion and conclusions The final session discussed opportunities, priorities and options for further developing EMCDDA s work in the area of HCV as well as highlighting current challenges and limitations. A number of suggestions were made as to how HCV treatment uptake among PWID in Europe could be promoted and monitored: 7

8 A. Inform national policies The Scottish HCV Action Plan was highlighted as a model of good practice. EMCDDA should summarise information on national policies and practice, as provided by the Focal Points in their National Reports, and could update the review of national treatment guidelines, with a focus on documenting current models of HCV treatment provision for PWID, identifying barriers for treatment access for this patient group and thus improve knowledge among European health policy makers. B. Provide guidance for practitioners A number of presentations highlighted the importance of integrated care and documented how referrals and compliance could be improved and outcomes of treatment optimized. EMCDDA should bring together good practices in the area of HCV treatment provision for PWID and explore in one document what it might take to deliver HCV and addictions treatment for a drug injector or a person with a history of injecting, i.e., guidance on how treatment and care could be organised, with the involvement of whom and when for the maximum possible treatment outcome for the individual, their own social network and society. C. Collect data on HCV treatment uptake among PWID It was suggested that the EMCDDA should explore options for collecting HCV treatment data. More specifically: a) It is important to establish what capacities are available at country level to utilise existing resources to try and get at the question of HCV treatment uptake among PWID and /or drug treatment clients; b) Possible approaches to HCV treatment uptake surveillance across Europe may include: i. Pharmaceutical registries linkage (feasible in a limited number of sites perhaps) - borrowing from pharmacoepidemiology, this method would allow the identification, in a defined geographical area, of all patients in receipt of opioid substitution medicines (step one) who are also in receipt of HCV therapy; potentially, this empirical approach can be extended to use (other) large health care databases (insurance claims, and electronic medical records across Europe) to assess HCV treatment uptake; ii. Surveys (where the OST / NSP /GP is the survey unit/subject) - would allow gathering data on HCV infection treatment uptake among PWID and or drug patient in Europe. Questions on HCV treatment uptake among PWID can be embedded in our own EMCDDA data collection infrastructures, i.e., Treatment Demand Indicator (TDI) or Drug Related Infectious Diseases (DRID); c) HCV treatment uptake monitoring could be supplemented with a systematic review of (un)published data on HCV treatment among PWID (drug users with a history of injecting); The major limitations identified are around: a) HCV prevalence data we currently have and the broad uncertainty of these data and the prevalence estimate; 8

9 b) self-reported HCV treatment status data (in the absence of potential for linkage to pharmaceutical registries). Overall, the National Focal Points (NFPs) present at the meeting identified with the priorities listed by the civil society representative. In fact a number of NFPs declared that in their countries, they are looking into changes, to include: improving the levels of HCV treatment provision for PWID and its integration with drug treatment. Scotland exemplifies the kind of policy response that other European countries are aspiring to in order to stimulate and facilitate those changes. There was agreement and support amongst all present regarding the need for treatment guidance and monitoring of HCV treatment uptake among PWID. A number of NFPs supported possible HCV treatment monitoring. 9

10 APPENDIX 1 Final AGENDA 24 th April 2012 Monitoring hepatitis C virus infection treatment uptake among people who inject drugs in Europe Venue: EMCDDA, Lisbon (Portugal) Objectives: to review the methodologies used across the world for monitoring hepatitis C virus (HCV) infection treatment uptake among people who inject drugs (PWID) to advance a pilot study looking at HCV infection treatment uptake among PWID in Europe 9.00 Meeting at the EMCDDA 9:15 9:30 Paul Griffiths: Welcome and introduction Chairs: Roland Simon and Teodora Groshkova 9:30 9:45 Lucas Wiessing: HCV among PWID in Europe brief overview 9:45 10:00 Natasha Martin and Peter Vickerman: HCV treatment as prevention 10:00 10:15 Jason Grebely: Monitoring HCV treatment uptake among PWID linking to pharmaceutical registries in Canada 10:15 10:30Questions and answers 10:30 11:00 Coffee-break Chairs: Teodora Groshkova and Dagmar Hedrich 11:00 11:15 Olav Dalgard: Monitoring HCV treatment uptake among PWID linking to pharmaceutical registries in Norway 11:15 11:30 Sharon Hutchinson: HCV treatment for PWID in Scotland 11:30 11:45 Maria Prins: HCV infection, treatment uptake and outcomes among PWID in the Amsterdam area 11:45 12:00 Philip Bruggmann: HCV treatment for PWID in Switzerland 12: Questions and answers 12:30 13:30 Lunch Chairs: Dagmar Hedrich and Teodora Groshkova :45 Jason Grebely: Monitoring HCV treatment uptake among PWID through surveys in Australia 13:45 14:00 Matthew Hickman: Pilot work on monitoring HCV treatment uptake among PWID in England :15 Vratislav Rehak: HCV treatment for PWID in Prague 14: Questions and answers 10

11 14:30 15:00 Coffee-break Chairs: Paul Griffiths and Dagmar Hedrich 15:00 15:15 Jens Reimer: HCV treatment uptake among PWID in Germany 15:15 15:45 Tim Rhodes: HCV treatment uptake among PWID: The role of qualitative research [15 minutes for Discussant, Luís Mendão] 15:45 17:00 Closing discussion and way forward 11