Evaluation of Zepatier in a community-based setting among cirrhotic and non-cirrhotic patients on stable opiate substitution therapy.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
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
Thompson Centre
Dublin, Ireland
Sustained viral response (SVR) against HCV at 12 weeks after treatment
Time frame: 12 weeks post-treatment
Sustained viral response (SVR) against HCV at 24 weeks after completion of study treatment
Time frame: 24 weeks post-treatment
Incidence of adverse events during course of treatment
Time frame: Weeks 0-16 of treatment
Characteristics of adverse events
Time frame: Week -8 pre-treatment to Week 24 post treatment
Incidence of treatment discontinuation over course of treatment
Time frame: Weeks 0-16 of treatment
Rates of premature discontinuation of drug for clinical or laboratory reasons
Time frame: Weeks 0-16 of treatment
Evaluation of percentage relapse at 12 and 24 weeks post treatment
Time frame: weeks 12 and 24 post treatment
Percentage of re-infection as evaluated by repeat HCV RNA positivity at weeks 12 and 24 post-treatment
Time frame: Weeks 12 and 24 post-treatment
Safety and feasibility of model of community based integrated care with community dispensation and supervision of DAA therapy to treat 'hard to reach' HCV infected patients
Time frame: End of study
Change of quality of life assessment questionnaire score (EQ-5D-5L) administered at baseline, 12 weeks, and 24 weeks post-treatment
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Time frame: End of study