Testing and Treating Hepatitis C in Community Pharmacies

Study Overview
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Brief Summary
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Hepatitis C Virus, (HCV), infection is a major health concern in the UK with up to 0.7% of the population infected. At best, 25% of those infected will clear the infection spontaneously, though for those who develop a chronic infection, they may go onto to develop liver cirrhosis or liver cancers. The standard of care within the NHS is that patients with a history of intravenous drug use or those currently on methadone are at high risk of having HCV infection and should be offered HCV testing. Once diagnosed they can be referred to nurse led treatment pathways. Less than 10% of the methadone users are even tested for HCV and of them fewer than 20% go onto treatment regimens that successfully clear the infection despite regular interactions with heath care staff. Pharmacists who have daily interactions with patients receiving methadone are ideally placed to deliver anti HCV therapy as they have daily contact with this client group and are well placed to advise on the drug therapy. The SuperDOT C study will examine the impact of pharmacy led Directly Observed Therapy (DOT) for HCV treatment in patients attending Community Pharmacies in participating Health Boards within NHS Scotland. The impact of this approach will be compared with those referred to standard care pathways on how well participants clear their HCV infection.

Detailed Description
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The SuperDOT-C study will evaluate a new pathway of care for patients on OST who are already receiving OST therapy on a daily basis from a pharmacist. Newer therapies for HCV have recently become much simpler to initiate and supervise with much improved effectiveness and as described below it is now proposed to extend the role of community pharmacists into initiating HCV therapy alongside the existing OST The SuperDOT-C study will utilise this existing environment and relationship to smooth the pathway into HCV therapy with co-administration of OST alongside the anti-HCV therapy under the supervision of the pharmacist compared with the established pathway of referral to another site and treatment with a nurse led ant-HCV treatment program. This new pathway may have positive effects on the movement towards HCV cure at multiple levels. The planned pathway is different to current care at each point, from testing and diagnosis through adherence to cure. In the planned pathway, the patient interacts with the pharmacist on a daily basis, as compared to intermittent interaction with a secondary care team member. The result being that the patient has a shorter care pathway, with less travelling and better access to anti-HCV treatment. The daily interaction with the pharmacy provides opportunities to assess and support the patient, provide sound advice and care, with the added benefit of being able to directly observe treatment, (DOT), thus potentially improving adherence.

Official Title
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A Cluster Randomised Trial of Pharmacy Led HCV Therapy Versus Conventional Treatment Pathways for HCV Positive Patients Receiving Daily OST in Pharmacies in Health Boards Within NHS Scotland

Conditions
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Hepatitis C

Intervention / Treatment
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* Other: Pharmacist Led
* Other: Nurse led


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV PCR positive, Stable OST dose for greater than 12 weeks prior to study enrolment Exclusion Criteria: Evidence of current or previous decompensated liver disease, Currently receiving HCV eradication treatment HIV infection, HBsAg positive with detectable HBV DNA, Pregnancy Cirrhosis or high fibrosis score Genotype deemed unsuitable for treatment with available study drugs Unable or unwilling to provide informed consent
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Led<br>This arm involved subjects following pathway of care and treatment delivery delivered by community pharmacists | Other: Pharmacist Led<br>* Trial of administering established, licensed treatments by a novel pathway, ie Community Pharmacists, which is hypothesized to improve treatment and retention in treatment of difficult to engage subjects<br>|
| Experimental: Nurse Led<br>This arm involved subjects following the conventional pathway of care and treatment delivery delivered by specialist secondary care nurses | Other: Nurse led<br>* Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Sustained Viral Response at 12 weeks, (SVR12), in pharmacy pathway compared with that of the current treatment pathway 12 weeks after completion of HCV therapy | Blood test result; PCR - based measurement of levels of hepatitis C virus. | 12 week SVR, (12 weeks post completion of HCV treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost effectiveness of the pharmacist pathway as compared with the conventional care pathway | Health economics analysis | Span of study ie 24 months | 
| To determine whether the Pharmacist-led pathway compared with the Conventional Pathway leads to more people on OST being tested and initiating treatment | Comparison of rate of HCV testing rates in pharmacist pathway compared with current pathway | Span of study ie 24 months | 
| To explore whether adherence and persistence to HCV therapy in the pharmacy setting is at least similar to that in the Conventional pathway | Comparison of compliance rates of antiviral medications between pharmacist and conventional pathway. | Span of study ie 24 months | 
| To compare the acceptability of the Pharmacist-led pathway versus the conventional treatment pathway for OST clients | Compare the acceptability of the pharmacist pathway as compare to conventional pathway of care | Span of study ie 24 months | 
| To measure re-infection rate at 1 year after end of treatment in patients with SVR | Comparison of the rate of reinfections with HCV between pharmacist and conventional pathways | Span of study ie 24 months | 
| To compare the number of patients who drop out of the study between the two pathways | Comparison of subject drop out rates between pharmacist and conventional pathways | Span of study ie 24 months |