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.

Cost-effectiveness of mass screening for Hepatitis C virus among all inmates in an Irish prison.

BACKGROUND: In Irish prisons, there is a high proportion of people who inject drugs (PWID; 26%) and a high prevalence of HCV (16%), making prison a high priority setting for HCV testing and treatment. We evaluate the cost-effectiveness of a mass HCV screening intervention in Mountjoy Prison, Dublin, compared to the standard-of-care of intermittent screening on committal. METHODS: Primary cost data was collected from the intervention using an overall provider perspective. Standard-of-care (SOC) costs were estimated through interview. All costs were inflated to 2020 Euros. An HCV transmission and disease progression model among incarcerated and community PWID and ex-injectors was calibrated to the Dublin HCV epidemic, allowing inclusion of population-level health benefits. The model used intervention data, suggesting 419 individuals were screened, 50 HCV infections diagnosed and 32 individuals initiated treatment, to project the resulting costs and health benefits (quality adjusted life years or QALYs) over 50 years with 5% discounting. The incremental cost effectiveness ratio (ICER), cost per QALY gained, was estimated for the screening intervention compared to the standard-of-care. Probabilistic sensitivity analyses (PSA) determined the probability that the intervention was cost-effective compared to a willingness-to-pay threshold of €30,000/QALY as used in Ireland. The ICER for 1- or 3-yearly mass screening in all Dublin prisons was also calculated. RESULTS: The total direct costs of the intervention (not including treatment drug costs) was €82,392, with most costs being due to staff (43%) and overhead or management costs (38%). Despite having little epidemiological impact due to the small numbers treated, over 50 years the incremental cost of the intervention was €36,592 and 3.8 QALYs were gained, giving a mean ICER of €9,552/QALY. The majority (84%) of PSA runs were below the willingness-to-pay threshold. Yearly mass screening had an ICER of €2,729/QALY compared to SOC and gave a higher net monetary benefit (€7,393,382) than screening every 3 years (€6,252,816). CONCLUSION: Prison mass screening could be a cost-effective initiative for increasing testing and treatment of HCV in Ireland.

HepCare Ireland-a service innovation project.

Hepatitis C virus (HCV) remains a major cause of morbidity and death worldwide, with prevalence highest among people who inject drugs (PWID), homeless populations and prisoners. The World Health Organization has published targets to be achieved by 2030 as part of its global health sector strategy to eliminate viral hepatitis. Recent innovations in testing and treatment of HCV mean such goals are achievable with effective infrastructure, political will and funding. 'HepCare Europe' was a 3-year, EU-funded project involving four member states. It sought to develop, implement and evaluate interventions to improve HCV outcomes through multiple-level interventions, running between 2016 and 2019. This paper aims to summarize the methods and present the aggregate cascade of care figures for the Irish components of HepCare. 'HepCare Ireland' contained five integrated work packages: HepCheck, HepLink, HepFriend, HepEd and HepCost. Interventions included intensified screening, community-based assessment, linkage to specialist care, peer training and support, multidisciplinary educational resources and cost-effectiveness analysis. A total of 812 participants were recruited across the three clinical work packages in Ireland. Two hundred and fifty-seven (31.7%) of the tested participants had an HCV antibody-positive result, with 162 (63.0%) testing positive for HCV RNA. At the time of writing (6th of November 2019), 57 (54.8%) of participants put on treatment had achieved SVR12, with 44 (42.3%) still undergoing treatment. In HepCheck, HepLink. HepEd and HepFriend, we demonstrate a series of interventions to improve Irish HCV outcomes. Our findings highlight the benefits of multilevel interventions in HCV care.

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.