Pharmacist-led Hepatitis C Management (PHARM-C)

Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C Virus Infection
• Intervention / Treatment: Behavioral: Pharmacist-Led care; Behavioral: Standard of Care (Hepatology)

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mia Biondi, PhD, NP-PHC; Phone Number: 6476286471; Email: mia.biondi@mail.mcgill.ca
• Study Contact Backup: Name: Jordan Feld, MD, MPH; Phone Number: 4163404584; Email: jordan.feld@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4Y 1G7
      • Recruiting
      • Specialty Rx Solutions
      • Contact: Jordan Feld, MD, MPH; Phone Number: 4163404584; Email: jordan.feld@uhn.ca
      • Contact: Mia Biondi, NP-PHC, PhD; Phone Number: 6476276461; Email: mbiondi@yorku.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community Pharmacist-Led; 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.	Behavioral: Pharmacist-Led care; Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
Active Comparator: Academic hepatology; Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.	Behavioral: Standard of Care (Hepatology); Rapid testing in a community pharmacy, with standard of care referral to academic hepatology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to treat by Completion Rates	Intention to treat direct acting antiviral (DAA) completion rates in non-cirrhotic or compensated cirrhotic patients treated with DAAs in pharmacist-led programs in community pharmacies, compared to treatment completion rates with referral and treatment in tertiary care hepatology (Toronto Centre for Liver Disease).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Virologic Response by Intention-to-Treat	Compare Sustained Virologic Response rates by Intention to treat in both sites.	24 months
Sustained Virologic Response by modified Intention-to-Treat	Compare the rates of Sustained Virologic Response by modified Intention to treat (including all participants who take at least one dose of medication)	24 months
Sustained Virologic Response by Per Protocol analysis	Compare the rates of Sustained Virologic Response by per protocol analysis including all individuals who complete treatment in both groups.	24 months
Hepatitis C Community seroprevalence in downtown Toronto	Determine the seroprevalence of HCV among individuals tested in downtown Toronto.	18 months
Community Pharmacist Fibrosis Identification	Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)	18 months
Community Pharmacist Decompensation Identification	Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)	18 months
Minimum Mean Time-to-Treatment	Determine the minimum mean time-to-treatment initiation in both groups	18 months
Community Appointment Adherence	Assess appointment adherence in both arms	24 months
Medication Adherence	Assess self-reported medication adherence at both sites	18 months
Quality of Life and Substance Use	Evaluate quality of life for patients with chronic liver disease (CLDQ-HCV) before and after treatment (endpoint and SV12) at both sites.	24 months
Substance Use	Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.	24 months
Patient Understanding and Satisfaction	Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)	24 months
Reinfection	Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.	24 months
Patient empowerment	Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey	24 months

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Point-of-care testing; Pharmacist-led; Rapid access to treatment; Service co-localization
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: 20-5265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No