Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations (ECLIPSE)

Study Overview
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Brief Summary
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Hepatitis C (HCV) is a chronic infection with significant morbidity and mortality. The development of directly acting antivirals (DAA) has dramatically improved the cure rate of HCV treatment. People who experience incarceration are disproportionately infected and often involved in ongoing transmission of disease. However, despite availability of effective treatment, people who experience incarceration are often unable to access this curative therapy, and are often not readily engaged in medical care upon release. This perpetuates transmission and progression of disease in an incredibly high risk, marginalized population. Therefore, in order to effectively eliminate HCV, it is imperative that the epidemic of HCV in prisons is addressed, and that models of care are established for treatment of HCV in incarcerated individuals, both during and after incarceration. As such, the investigators propose a comprehensive model of care to engage incarcerated individuals in treatment of HCV upon release from prison. This care is provided in conjunction with collocated services to prevent HCV reinfection, including opioid agonist therapy. This pilot trial will demonstrate whether a comprehensive model of care can effectively cure HCV in recently incarcerated individuals, while simultaneously treating opioid use disorder and preventing HCV reinfection.

Official Title
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Elimination of HCV Through Linkage and In Prison Treatment of Incarcerated Populations

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: Glecaprevir/pibrentasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 18 years old Able and willing to sign informed consent For the community linkage arm: Chronically infected with HCV, defined as any individual with documentation of positive HCV antibody and positive HCV RNA test (HCV RNA of 2,000 IU/mL or greater). For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC Exclusion Criteria: Decompensated cirrhosis (Child-Pugh B or C) Pregnant or breastfeeding women For community linkage arm: Prior treatment with a direct acting antiviral regimen For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir Poor venous access not allowing screening laboratory collection Have any condition that the investigator considers a contraindication to study participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: In prison treatment arm<br>Of patients who achieved SVR, 100 inmates will be enrolled for long-term monitoring for re-infection after they have completed treatment. Patients will be seen every 6 months to test for reinfection, however they will not be subject to any medical or behavioral interventions through the study team. Limited opioid agonist therapy may be available as per the standard practice of the DOC, however syringe exchange and other harm reduction services will not be accessible to inmates, per DOC policy. | |
| Active Comparator: Community Linkage - Rapid Initiation Arm<br>The rapid initiation group will receive HCV medication immediately upon release from prison/jail. | Drug: Glecaprevir/pibrentasvir<br>* Treatment for HCV Infection<br>|
| Active Comparator: Community Linkage - Clinic-Based Initiation Arm<br>The group will receive medication after attending first ANCHOR clinic visit. | Drug: Glecaprevir/pibrentasvir<br>* Treatment for HCV Infection<br>|
| No Intervention: In prison - Retrospective Review<br>a retrospective review of de-identified available data provided by the DOC for all patients previously treated with DAAs through standard of care in the DOC will be reviewed for rates of SVR. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained Virologic Response (SVR) in the community linkage arm | Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy. | 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective rates of SVR in the In prison arm | Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy. | 6 months after treatment | 
| Treatment Initiation Rates | Rates of treatment initiation in the CL arm (defined as taking one dose of direct acting antiviral) | 6 months | 
| OAT uptake Rates | Rates of OAT uptake in the CL arm (defined as completion of OAT induction) | 12 months | 
| HCV Reinfection Rates | Reinfection (defined as documentation of infection with a different HCV genotype than at baseline before treatment, or if the same genotype, viremia after SVR determination, or phylogenetic analysis shows a different virus strain than the pre treatment baseline strain) | 24 months | 
| Comparison between Rapid Initiation and Clinic-base Initiation | Comparative efficacy of rapid initiation (RI) and clinic-based initiation (CB) arms, comparing the rates of SVR in patients who were randomized to the RI arm compared to patients randomized to the CB arm. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV infection, Incarcerated individuals