Pharmacist-led Hepatitis C Management (PHARM-C)

University Health Network, Toronto

Status and phase: Unknown; Phase 4

Conditions: Hepatitis C Virus Infection

Treatments: Behavioral: Standard of Care (Hepatology); Behavioral: Pharmacist-Led care

Study type: Interventional

Funder types: Other

Identifiers

NCT04322981

20-5265

Details and patient eligibility

About

Hepatitis C virus (HCV) continues to disproportionately affect vulnerable and marginalized persons in Canada. During the interferon treatment era, certain circumstances precluded individuals from receiving treatment, most notably mental health concerns or active substance use. In addition to the tolerability and efficacy of all-oral direct acting antivirals (DAAs), novel diagnostic strategies have also increased engagement in the care cascade. Point-of care and/or dried blood spot antibody as well as RNA testing allow for diagnosis without the need for phlebotomy, a major barrier for those with a history of past or current injection drug use. Despite these advances in diagnostic streamlining and increased cure rates, engagement post-diagnosis continues to be a major gap. Although the exact mechanism of HCV acquisition may not be clear - people who inject drugs, persons who are street-involved or low-income, or persons who are difficult-to-reach for other reasons, often experience both structural and geographic challenges to obtaining care. Community pharmacists may be the first point of contact for higher risk populations and may avoid testing and/or treatment for fear of judgement or poor treatment in hospital/specialist settings. While studies have demonstrated the feasibility of treating people receiving opioid against therapy (OAT), it remains unclear whether Canadian pharmacists can safely and effectively screen, and/or confirm HCV, work-up patients for HCV treatment, and prescribe with minimal oversight. If this model proves successful, it may have global utility especially in areas of the world where pharmacists are the initial point of contact for healthcare issues. The aim of this study is to determine whether being tested and linked care and treatment will be more effective in a community pharmacy than a referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HCV infection
2. HCV RNA > 1,000 IU/mL
3. Aged 18 to 80
4. Willingness and capacity to provide informed consent

Exclusion criteria

1. Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and Model for Endstage Liver Disease (MELD) score will also be used to assess this using laboratory investigations and clinical findings.
2. Platelets < 75,000/mm3, total albumin <35 g/L, total bilirubin (total and direct) >34.2 μmol/L, International Normalized Ratio (INR) >1.5
3. History of current or past hepatocellular carcinoma
4. Hepatitis B virus (HBV) co-infection as indicated by positive testing for hepatitis B surface antigen (HBsAg +ve)or untreated HIV co-infection
5. Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
6. Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
7. Significant co-morbid illness that precludes inclusion in the opinion of the investigator
8. Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
9. Pregnancy/breast-feeding/inability to use contraception
10. Use of concomitant contraindicated drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Community Pharmacist-Led

Experimental group

Description:

Patients in Arm 1 will receive care and treatment at their home pharmacy and be evaluated and treated by a community pharmacist under medical directives and with study oversight.

Treatment:

Behavioral: Pharmacist-Led care

Academic hepatology

Active Comparator group

Description:

Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.

Treatment:

Behavioral: Standard of Care (Hepatology)