Clinical trial NCT04322981: Pharmacist-led Hepatitis C Management
Official title: Pharmacist-led Hepatitis C Diagnosis and Rapid Management - in Community
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C Virus Infection
Keywords: Point-of-care testing
Rapid access to treatment
Pharmacist-led
Service co-localization
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Screening, evaluation and treatment at an outpatient pharmacy compared to referral to hepatology clinics
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intention to treat by Completion Rates
timeFrame: 24 months
Secondary outcomes:
measure: Sustained Virologic Response by Intention-to-Treat
timeFrame: 24 months
measure: Sustained Virologic Response by modified Intention-to-Treat
timeFrame: 24 months
measure: Sustained Virologic Response by Per Protocol analysis
timeFrame: 24 months
measure: Hepatitis C Community seroprevalence in downtown Toronto
timeFrame: 18 months
measure: Community Pharmacist Fibrosis Identification
timeFrame: 18 months
measure: Community Pharmacist Decompensation Identification
timeFrame: 18 months
measure: Minimum Mean Time-to-Treatment
timeFrame: 18 months
measure: Community Appointment Adherence
timeFrame: 24 months
measure: Medication Adherence
timeFrame: 18 months
measure: Quality of Life and Substance Use
timeFrame: 24 months
measure: Substance Use
timeFrame: 24 months
measure: Patient Understanding and Satisfaction
timeFrame: 24 months
measure: Reinfection
timeFrame: 24 months
measure: Patient empowerment
timeFrame: 24 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Specialty Rx Solutions
state: Ontario
Study officials:
References: