NCT03935906: REACH HCV

Reaching mEthadone Users Attending Community pHarmacies With HCV

Completed NA Last updated 13 October 2021

What this trial tests

NA trial testing Reach Pathway in Hepatitis C in 210 participants. Completed in 14 January 2021.

Timeline

8 October 2019

Primary endpoint
14 January 2021

14 January 2021

Quick facts

Lead sponsor	University of Dundee
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	210
Start date	8 October 2019
Primary completion	14 January 2021
Estimated completion	14 January 2021
Sites	3 locations across United Kingdom, Australia

Drugs / interventions tested

• Reach Pathway
• Education-only Pathway

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →

Sponsor

University of Dundee

Who can join

18 and older, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Hepatitis C Virus (HCV) is a blood-borne virus that damages the liver and is a major public health threat globally. Most individuals infected with HCV are unaware of it and show no symptoms until presenting with incurable, fatal end-stage disease. In Scotland and Australia approximately 0.7% of the general population has chronic HCV with 0.4% in Wales, and they are at risk of developing cirrhosis and hepatocellular carcinoma. The clinical challenge is to identify those infected and bring them into treatment before the disease advances.

The greatest risk factor for acquiring HCV in many countries is through injecting drug use. On the road to recovery from drug use, many will receive long-term opiate substitution therapy (OST), commonly with methadone or buprenorphine. Internationally, OST is routinely dispensed by a community pharmacist. HCV testing can be offered by GPs, drugs workers, drug agencies, social workers, community pharmacies and needle exchange sites. Once patients are diagnosed, they are referred to a hospital-based service to receive anti-HCV treatment. In this pathway, less than 10% of the OST population is tested per year, and cumulative rates of testing are less than 50% of those on OST.

Highly effective Directly Acting Antiviral (DAA) treatment combinations are now available and achieve HCV cure rates in excess of 95%, with once or twice daily tablets for 8-24 weeks.

The REACH HCV study will compare efficacy of an education-only HCV referral and treatment pathway against a nurse-led point-of-care device testing and treatment pathway among OST patients in community pharmacies in Scotland, Wales and Australia. Eligible participants will be treated using DAAs.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Reaching people receiving opioid agonist therapy at community pharmacies with hepatitis C virus: an international randomised controlled trial.
   Byrne CJ, Radley A, Inglis SK, Beer L, et al · · 2022 · cited 14× · PMID 35538396 · DOI 10.1111/apt.16953
2. <u>R</u>eaching m<u>E</u>thadone users <u>A</u>ttending <u>C</u>ommunity p<u>H</u>armacies with HCV: an international cluster randomised controlled trial protocol (REACH HCV).
   Byrne C, Radley A, Inglis SK, Beer LJZ, et al · · 2020 · cited 11× · PMID 32868356 · DOI 10.1136/bmjopen-2019-036501
3. Lessons learned from two multicentre randomised controlled trials undertaken in pharmacies in community settings: a retrospective project management analysis.
   Byrne CJ, Inglis SK, Radley A, Beer LJ, et al · · 2025 · PMID 41174772 · DOI 10.1186/s13063-025-09196-9