Pharmacist-led Hepatitis C Management

Hepatitis C Virus Infection Clinical Trial

— PHARM-C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322981
• Other study ID #: 20-5265
• Status: Recruiting
• Phase: Phase 4
• Start date: April 13, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2021
• Source: University Health Network, Toronto
• Contact: Mia Biondi, PhD, NP-PHC
• Phone: 6476286471
• Email: mia.biondi[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection

Intervention

Behavioral:
• Pharmacist-Led care
Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
• Standard of Care (Hepatology)
Rapid testing in a community pharmacy, with standard of care referral to academic hepatology

Locations

Country	Name	City	State
Canada	Specialty Rx Solutions	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sustained Virologic Response by Intention-to-Treat	Compare Sustained Virologic Response rates by Intention to treat in both sites.	24 months
Secondary	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
Secondary	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
Secondary	Hepatitis C Community seroprevalence in downtown Toronto	Determine the seroprevalence of HCV among individuals tested in downtown Toronto.	18 months
Secondary	Community Pharmacist Fibrosis Identification	Comparison of pharmacist-assessed fibrosis stage vs fibrosis stage assessed by hepatologist (gold standard)	18 months
Secondary	Community Pharmacist Decompensation Identification	Comparison of pharmacist-assessed hepatic decompensation score vs hepatic decompensation assessed by hepatologist (gold standard)	18 months
Secondary	Minimum Mean Time-to-Treatment	Determine the minimum mean time-to-treatment initiation in both groups	18 months
Secondary	Community Appointment Adherence	Assess appointment adherence in both arms	24 months
Secondary	Medication Adherence	Assess self-reported medication adherence at both sites	18 months
Secondary	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
Secondary	Substance Use	Evaluate the Maudsley Addiction Profile (MAP) before and after treatment (endpoint and SV12) at both sites.	24 months
Secondary	Patient Understanding and Satisfaction	Compare patient understanding and satisfaction with HCV treatment with the Hepatitis Patient Satisfaction Questionnaire (HPSQ)	24 months
Secondary	Reinfection	Assess rates of reinfection in patients who achieve Sustained Virologic Response, at 48 weeks.	24 months
Secondary	Patient empowerment	Compare measure of patient empowerment by treatment-arm using the Health Care Empowerment (HCE) survey	24 months