Exploring and understanding HCV patient journeys- HEPCARE Europe project.

BACKGROUND: Hepatitis C Virus (HCV) is a leading cause for chronic liver diseases worldwide. The European Union and World Health Organization aspire to eliminate HCV by 2030. However, among at-risk populations, including, homeless people, prisoners and People Who Inject Drugs, access to diagnosis and treatment is challenging. Hepcare Europe is an integrated model of care developed to address this by assessing potential reasons for these restrictions and determining measures needed to improve HCV diagnosis, treatment and access to care within different communities. OBJECTIVES: HepCare Europe is an EU-supported project involving collaboration between five institutions in: Ireland, United Kingdom, Spain and Romania. We aim to explore the journey of care experienced by those living with HCV with a focus on previous care disruptions (loss to follow up) and the new HepCare Europe Programme. METHODS: Research teams conducted semi-structured interviews with patients who accessed services through HepCare Europe thus, patients were recruited by purposeful sampling. Patients interviewed had received, or were in the final weeks of receiving, treatment. The interviews were audio recorded, transcribed and translated into English, and sent to the Dublin team for inductive thematic analysis. Researchers from the HepCare Europe research team coded the data separately, then together. RESULTS: Common themes are introduced to present similarities, following individual site themes to highlight the importance of tailored interventions for each country. Key themes are: 1) Hepatitis C patients lost to follow up 2) HepCare improved access to treatment and 3) the need for improved HCV education. Individual themes also emerged for each site. These are: Ireland: New opportunities associated with achieving Sustained Virologic Responses (SVR). Romania: HCV is comparatively less crucial in light of Human Immunodeficiency Viruses (HIV) coinfections. UK: Patients desire support to overcome social barriers and Spain: Improved awareness of HCV, treatment and alcohol use. CONCLUSION: This study identified how the tailored HepCare interventions enabled improved HCV testing and linkage to care outcomes for these patients. Tailored interventions that targeted the needs of patients, increased the acceptability and success of treatment by patients. HepCare demonstrated the need for flexibility in treatment delivery, and provided additional supports to keep patients engaged and educated on new treatment therapies.

Integrating Hepatitis C Care for Opioid Substitution Treatment Patients Attending General Practice: Feasibility, Clinical, and Cost-Effectiveness Analysis.

BACKGROUND: Hepatitis C virus (HCV) infection is common among people who inject drugs, yet well-described barriers mean that only a minority have accessed HCV treatment. Recent developments in HCV diagnosis and treatment facilitate innovative approaches to HCV care that improve access to, and uptake of, care by people who inject drugs. OBJECTIVE: This study aims to examine feasibility, acceptability, likely clinical effectiveness, and cost-effectiveness of an integrated model of HCV care for patients receiving opioid substitution treatment in general practice. METHODS: A pre- and postintervention design with an embedded economic analysis was used to establish the feasibility, acceptability, and clinical and cost-effectiveness of a complex intervention to optimize HCV identification and linkage to HCV treatment among patients prescribed methadone in primary care. The "complex intervention" comprised general practitioner (GP)/practice staff education, nurse-led clinical support, and enhanced community-based HCV assessment of patients. General practices in North Dublin were recruited from the professional networks of the research team and from GPs who attended educational sessions. RESULTS: A total of 135 patients from 14 practices participated. Follow-up data were collected 6 months after intervention from 131 (97.0%) patients. With regard to likely clinical effectiveness, among patients with HCV antibody positivity, there was a significant increase in the proportions of patients who had a liver FibroScan (17/101, 16.8% vs 52/100, 52.0%; P<.001), had attended hepatology/infectious diseases services (51/101, 50.5% vs 61/100 61.0%; P=.002), and initiated treatment (20/101, 19.8% vs 30/100, 30.0%; P=.004). The mean incremental cost-effectiveness ratio of the intervention was €13,255 (US $13,965.14) per quality-adjusted life-year gained at current full drug list price (€39,729 [US $41,857.48] per course), which would be cost saving if these costs are reduced by 88%. CONCLUSIONS: The complex intervention involving clinical support, access to assessment, and practitioner education has the potential to enhance patient care, improving access to assessment and treatment in a cost-effective manner.

HepCare Europe-A service innovation project. HepCheck: Characteristics of the patient population with active infection as defined by HCV RNA.

BACKGROUND: Hepatitis C virus (HCV) is a main cause of chronic liver disease worldwide and is consistently under-diagnosed. Community-based screening initiatives, such as HepCheck, have been identified as important components of HCV care. HepCheck focuses on screening and identifying HCV RNA-positive cases in high-risk populations and linking them to care as part of a larger European project to improve HCV care (HepCare). METHODS: HCV testing with a self-administered questionnaire was offered to 2822 individuals. RESULTS: There were 2079 patients screened. Overall, 397 (19%) of the total screened cohort were identified as having active HCV infections as measured by HCV RNA PCR. The patients were mostly male (84%), white (88%), and had a history of injecting drug use (IDU) (86%), homelessness (58%), and tattooing (42%). There were 136 new cases (7% of the total sample and 34% of identified active infections). Romania had the highest proportion of newly identified cases with 87%, then Ireland with 60%, and Spain with 43%; the UK had the lowest proportion of new cases at 10%. CONCLUSIONS: For those lost to follow-up, a major strategy is re-engagement. For those newly diagnosed, the 'seek and treat' approach is a key strategy. Thus, different priorities are defined for different countries.

HEPCARE EUROPE- A case study of a service innovation project aiming at improving the elimination of HCV in vulnerable populations in four European cities.

OBJECTIVES: Hepatitis C Virus (HCV) is a significant cause of chronic liver disease. Among at-risk populations, access to diagnosis and treatment is challenging. We describe an integrated model of care, Hepcare Europe, developed to address this challenge. METHODS: Using a case-study approach, we describe the cascade of care outcomes at all sites. Cost analyses estimated the cost per person screened and linked to care. RESULTS: A total of 2608 participants were recruited across 218 clinical sites. HCV antibody test results were obtained for 2568(98•5%); 1074(41•8%) were antibody-positive, 687(60•5%) tested positive for HCV-RNA, 650(60•5%) were linked to care, and 319(43•5%) started treatment. 196(61•4%) of treatment initiates achieved a Sustained Viral Response (SVR) at dataset closure, 108(33•9%) were still on treatment, eight (2•7%) defaulted from treatment, and seven (2•6%) had virologic failure or died. The cost per person screened varied from €194 to €635, while the cost per person linked to care varied from €364 to €2035. CONCLUSIONS: Hepcare enhanced access to HCV treatment and cure, and costs were affordable in all settings, offering a framework for scale-up and reproducibility.

Hepatitis C Prevalence and Management Among Patients Receiving Opioid Substitution Treatment in General Practice in Ireland: Baseline Data from a Feasibility Study.

BACKGROUND: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and death. Injection drug use is now one of the main routes of transmission of HCV in Ireland and globally with an estimated 80% new infections occurring among people who inject drugs (PWID). OBJECTIVE: We aimed to examine whether patients receiving opioid substitution therapy in primary care practices in Ireland were receiving guideline-adherent care regarding HCV screening. Ireland has developed a model of care for delivering opioid substitution treatment in the primary care setting. We conducted this study given the shift of providing care for PWID from secondary to primary care settings, in light of current guidelines aimed at scaling up interventions to reduce chronic HCV infection and associated mortality. METHODS: We included baseline data from the Dublin site of the Heplink study, a feasibility study focusing on developing complex interventions to enhance community-based HCV treatment and improve the HCV care pathway between primary and secondary care. We recruited 14 opioid substitution treatment-prescribing general practices that employed the administration of opioid substitution therapy from the professional networks and databases of members of the research consortium. A standardized nonprobability sampling framework was used to identify 10 patients from each practice to participate in the study. Patients were eligible if aged ≥18 years, on opioid substitution treatment, and attending the practice for any reason during the recruitment period. The baseline data were collected from the clinical records of participating patients. We collected and analyzed data on demographic characteristics, care processes and outcomes regarding HCV and other blood-borne viruses, urinalysis test results, alcohol use disorders, chronic illness, and health service utilization. We examined whether patients received care concordant with guidelines related to HCV screening and care. RESULTS: The baseline data were collected from clinical records of 134 patients; 72.2% (96/134) were males; (mean age 43, SD 7.6; range 27-71 years); 94.8% (127/134) of patients had been tested for anti-HCV antibody in their lifetime; of those, 77.9% (99/127) tested positive. Then, 83.6% (112/134) of patients had received an HIV antibody test in their lifetime; of those, 6.3% (7/112) tested HIV positive. Moreover, 66.4% (89/134) of patients had been tested for hepatitis B virus in their lifetime and 8% (7/89) of those were positive. In the 12 months before the study, 30.6% (41/134) of patients were asked about their alcohol use by their general practitioner, 6.0% (8/134) received a brief intervention, and 2.2% (3/134) were referred to a specialist addiction or alcohol treatment service. CONCLUSIONS: With general practice and primary care playing an increased role in HCV care, this study highlights the importance of prioritizing the development and evaluation of real-world clinical solutions that support patients from diagnosis to treatment completion.