Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT03935906

Reaching mEthadone Users Attending Community pHarmacies With HCV

Sponsor: University of Dundee

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1410

Start Date

2019-10-08

Completion Date

2021-01-14

Last Updated

2026-07-17

Healthy Volunteers

Conditions

Hepatitis C

Interventions

OTHER

Reach Pathway

Trial of outreach nurse offering point-of-care Hepatitis C (HCV) testing to opiate substitution therapy patients in community pharmacies, which is hypothesised to improve number of patients tested and cured of HCV.

OTHER

Education-only Pathway

Trial of community pharmacists advising opiate substitution therapy patients to attend a local blood-borne virus clinic to be tested for Hepatitis C by a specialist nurse, which represents the standard care pathway for HCV patients in the countries included in the study.

Inclusion Criteria: * Over 18 years of age. * Previous or current injecting drug user. * Stable OST dose for greater than 12 weeks prior to study enrolment. * Glecaprevir/pibrentasvir treatment naïve. * Able to voluntarily sign and date an informed consent form prior to initiation of any screening or study specific procedures. * Able to understand and adhere to study visit schedule and all other protocol requirements. Exclusion Criteria: * Female who is pregnant, planning to become pregnant or breastfeeding or unwilling/unable to take appropriate birth control. * Known current HIV infection. * Known current HBV infection. Serological: patients with a positive HBsAg or isolated positive anti-HBC will be excluded from the study and followed up in secondary care. * Previous treatment with glecaprevir/pibrentasvir. * Currently taking any concomitant medication that has a warning of'do not co-administer' with glecaprevir and/or pibrentasvir as defined by the Liverpool Hep drug interactions website and product SmPC. * Clinically significant abnormalities that make candidate unsuitable for this study in the opinion of the investigator including but not limited to: * Uncontrolled cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric or other medical disease or disorder, which is unrelated to existing HCV infection. * History of either current or previous decompensated liver disease or symptoms/signs of decompensation e.g. ascites noted on physical exam, use of beta-blockers for portal hypertension, hepatic encephalopathy or oesophageal variceal bleeding. * Candidate is deemed unsuitable to receive study drugs by the study investigator, for any reason according to clinical judgement. * Unable or unwilling to provide informed consent. * History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs. * Drug-drug Interaction which may have safety concerns with any concomitant medication the patient is receiving including non-prescribed and/or recreational drugs.

Locations (3)

The Burnet Institute

Melbourne, Australia

NHS Tayside

Dundee, Scotland, United Kingdom

Public Health Wales

Cardiff, Wales, United Kingdom