Pharmacist-led Hepatitis C Management

Phase 4

• Conditions: Hepatitis C Virus Infection
• Interventions: Behavioral: Pharmacist-Led care; Behavioral: Standard of Care (Hepatology)

• Registration Number: NCT04322981
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-03-24
• Study First Posted: 2020-03-26
• Status Verified: 2021-12
• Study Start: 2022-04-13
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-27
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Pharmacist-Led	Pharmacist-Led care	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.
Academic hepatology	Standard of Care (Hepatology)	Patients in Arm 2 will be evaluated and treated by hepatologists at the Toronto Centre for Liver Disease.

Primary Outcome Measures

Name	Time	Method
Intention to treat by Completion Rates	24 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Specialty Rx Solutions; 🇨🇦 Toronto, Ontario, Canada