NCT02895958

The Dublin Zepatier Study

Open Label Study of the Safety and Efficacy of FDC Zepatier (Elbasvir+Grazoprevir +/- Ribavirin)Administered in a Community Based Setting to HCV Infected G1/4 Treatment naïve Patients on Stable Opiate Substitution Therapy With Cirrhotic and Non-cirrhotic Liver Disease

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Mater Misericordiae University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic patients on stable opiate substitution therapy.

Detailed description

Hard-to-reach groups such as those attending addiction and homeless services are particularly at risk for HCV-associated liver disease progression as they do not engage in treatment, have poor attendance records for appointments, and are at risk of progression to cirrhosis without evaluation and detection. These patients are therefore "silently" progressing in the community and may be close to decompensation. Once a patient goes over that critical stage from compensated to decompensated cirrhosis, the cost to the patient in terms of their health, and the cost to the state in terms of the management of cirrhosis related complications are great. As part of this investigator-led community-based treatment protocol we aim to demonstrate the utility of an integrated community-based care partnership between primary and secondary care to best evaluate and treat such hard to reach populations. We aim to actively find fibrosis levels of HCV related liver disease using the FibroScan diagnostic tool, and support patients to be treated for their HCV with the newly available DAAs and be cured of their HCV infection and disease through: 1. Active case finding by travelling to the services used by 'at risk' groups as opposed to giving appointments to the patient to attend hospital. 2. Locating HCV patients (with positive RNA or HCV antigen) that are 'lost to follow up'. 3. Staging and risk-stratifying HCV patients locally to support access to therapy. 4. Educating HCV patients around new assessment tools and treatments. 5. Setting up and supporting the initiation of treatment in the community e.g. daily dispensing of medication/treatment with methadone. 6. Providing on-going harm reduction advice on preventing reinfection. 7. Work in partnership with Methadone prescribing GP practices and Drug Treatment Centres from the North and South Dublin catchment area

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Zepatier	Zepatier (elbasvir and grazoprevir +/- Ribavirin) will be administered in a community setting to HCV infected G1/4 treatment naïve patients on stable opiate substitution therapy with Cirrhotic and Non-cirrhotic liver disease

Timeline

• Start date: 2018-03-15
• Primary completion: 2019-05-23
• Completion: 2019-12-06
• First posted: 2016-09-12
• Last updated: 2019-12-10

Locations

1 site across 1 country: Ireland