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Department of Corrections unable to support study at this time and find agreement on publication issue.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Maryland Department of Public Safety and Correctional Services | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In prison treatment arm | No Intervention | 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. | |
| Community Linkage - Rapid Initiation Arm | Active Comparator | The rapid initiation group will receive HCV medication immediately upon release from prison/jail. |
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| Community Linkage - Clinic-Based Initiation Arm | Active Comparator | The group will receive medication after attending first ANCHOR clinic visit. |
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| In prison - Retrospective Review | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glecaprevir/pibrentasvir | Drug | Treatment for HCV Infection |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elana Rosenthal, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore City Detention Center | Baltimore | Maryland | 21202 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000654128 | glecaprevir and pibrentasvir |
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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 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |