Preliminary Analysis of the Superdot-C Study: A Cluster Randomised Controlled Trial of Pharmacy Led Versus Conventional Treatment for HCV Positive Patients Receiving Daily Opioid Substitution Therapy Within NHS ScotlandPreliminary Analysis of the Superdot-C Study: A Cluster Randomised Controlled Trial of Pharmacy Led Versus Conventional Treatment for HCV Positive Patients Receiving Daily Opioid Substitution Therapy Within NHS Scotland


Author: Radley AS, de Bruin M, Inglis SK, Donnan PT, Beer LJ, Barclay S, Fraser A, Dillon JF

Theme: Epidemiology & Public Health Research Year: 2018

Background:
The elimination of Hepatitis C (HCV) requires greater access to testing and
treatment to at-risk groups. People prescribed Opioid Substitution Therapy (OST)
are at high risk of HCV infection. Community pharmacists see this group frequently
to provide OST. We report preliminary results of a randomised controlled trial of a
pharmacist-led ‘test & treat’ pathway vs conventional care.
Methods:
55 community pharmacies in a cluster randomised trial provided either conventional
or pharmacy-led care. Patients were recruited to the study if they were HCV antibody
positive by DBST. For conventional care, pharmacists referred participants to a local
centre for assessment. In the pharmacy-led arm, pharmacists assessed participants
for DAA treatment. Drug prescribing was by nurse prescribers (conventional arm) or
pharmacist prescribers (pharmacy-led arm). Treatment was delivered as daily
modified directly observed therapy (DOT) in a pharmacy. Primary trial outcome was
sustained viral response 12 weeks (SVR12) after treatment completion. The study is
now closed and in follow-up.
Results:
354 participants were recruited from a pool of 2718 OST recipients, 214 in the
pharmacy-led arm (1365 OST recipients) and 140 in the conventional arm (1353
OST recipients). In the pharmacy-led arm; 112 (52%) accessed treatment, 65 have
achieved SVR12 so far with 1 failure. 6 participants dropped out (2 deaths, 2 patient
choice, 1 pregnancy and 1 moved away). Of the conventional arm patients; 62 (44%)
received treatment, 26 have achieved SVR12 so far, 2 failed. 3 dropped out (1
patient choice, 2 moved away).
Conclusion:
Preliminary analysis suggests that the pharmacy-led pathway increased both
consent to, and initiation of, treatment. The offer of testing, assessment and
treatment with DAAs in a pharmacy increased HCV treatment uptake in people on
OST. The delivery of treatment within the familiar setting of the community
pharmacy was central to the success of the model.
Disclosure of Interest Statement: See example below:
This study was funded by the Scottish Government with donated drug by Gilead and
Bristol-Myers Squibb.
Note: If accepted into the programme you will be requested to include a disclosure
of interest slide into your presentation or include such statements in your poster.

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