Hepatitis C virus (HCV) infection is a major cause of chronic liver disease and death. Drug use remains the significant cause of new infections in the European Union (EU), with estimates of HCV antibody prevalence among people who inject drugs (PWID) ranging from 5% to 90% in 29 European countries.¹ In the Republic of Ireland and the EU, primary care is a key area to focus efforts to enhance HCV diagnosis and treatment among PWID. Recently developed HCV direct-acting antiviral drugs are well tolerated and delivered for shorter courses (8–12 weeks), with trials reporting more than 90% cure rates among PWID.² However, despite these highly effective treatments, many people at risk are unaware of their infection and obstacles may limit access to HCV care, resulting in many patients not being treated.

A recent paper, published in the journal JMIR Research Protocols, outlines the protocol for a study which will examine integrated HCV care for PWID.³ The research will be a prospective, non-randomised, pre–post intervention feasibility study, and will be conducted in opioid substitution treatment (OST)-prescribing general practices from three sites across the HepCare Europe consortium (Dublin, London and Seville). A total of 24 OST-prescribing general practices have been recruited from the professional networks and databases of members of the research consortium. Patients were eligible for inclusion in the study if aged ≥18 years, on OST, and had attended the practice for any reason during the recruitment period. Baseline data on HCV care processes and outcomes were extracted from the clinical records of the participating patients.

Intervention and outcomes

The aim of the intervention is to enhance identification and linkage to HCV care and treatment among patients attending primary care for OST. It includes the following:

• Outreach of an HCV-trained liaison nurse into general practices
• In-practice education for clinicians regarding developments in diagnosis and treatment of HCV
• Enhanced access of patients to community-based evaluation of HCV disease, including novel approaches to diagnosis
• A researcher-facilitated practice audit of HCV care processes and feedback to general practices.

Primary outcomes measures of the study will include the proportion of participants who have been screened for HCV and the proportion of HCV antibody-positive patients who commenced/completed antiviral therapy and who achieved a sustained virologic response. Secondary outcomes will include the following:

• The proportion of those screened who tested HCV antibody positive
• The proportion of HCV-positive patients who have been assessed using novel approaches
• The proportion of HCV-positive patients who have been referred to specialist hepatology or infectious disease services
• The proportion of HCV-positive patients who have attended specialist hepatology or infectious disease services
• The proportion of HCV-positive patients who received an alcohol screening brief intervention
• The proportion of participants tested for anti-HIV antibody, anti-HBc (hepatitis B core) antibody, or hepatitis B surface antigen (HBsAg)
• The proportion of participants immunised against hepatitis B/A virus
• The experience and evaluation of the intervention among key informants (clinicians and patients)
• The number of patients attending general practice for OST post-intervention for follow-up testing
• Evaluation of the feasibility and possible efficacy of the intervention by comparing pre–post intervention data
• Evaluation of the cost-effectiveness of the intervention
• Comparison of clinician knowledge, attitudes and practice pre–post intervention.

Conclusions

The authors of this research protocol state that the study is ongoing and has the potential to make an important impact on patient care and provide high-quality evidence to help clinicians make important decisions on HCV testing and onward referral. As a substantial proportion of HCV-positive patients on OST in general practice are not engaged with specialist hospital services, but qualify for direct-acting antiviral drugs treatment, the study has the potential to reduce HCV-related morbidity and mortality.

2  Dore GJ, Altice F, Litwin AH, Dalgard O, Gane EJ, Shibolet O, et al. (C-EDGE CO-STAR Study Group) (2016) Elbasvir-Grazoprevir to treat hepatitis C virus infection in persons receiving opioid agonist therapy: a randomized trial. Ann Intern Med, 165(9): 625-34.

3  McCombe G, Swan D, O’Connor E, Avramovic G, Vickerman P, Ward Z, et al. (2018) Integrated hepatitis C care for people who inject drugs (Heplink): protocol for a feasibility study in primary care. JMIR Res Protoc, 7(6): e149. https://www.drugsandalcohol.ie/29155/