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

University of Maryland Baltimore (UMB)

Status and phase: Withdrawn; Phase 4

Conditions: HCV Infection

Treatments: Drug: Glecaprevir/pibrentasvir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04235049

HP-00088498

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age greater than or equal to 18 years old
2. Able and willing to sign informed consent
3. 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).
4. For the community linkage arm: ineligible for treatment through the prison/jail without a known sentence longer than 9 months, as of consent date
5. For the in-prison arm: Achievement of SVR through the previous standard of care treatment through the DOC

Exclusion criteria

1. Decompensated cirrhosis (Child-Pugh B or C)
2. Pregnant or breastfeeding women
3. For community linkage arm: Prior treatment with a direct acting antiviral regimen
4. For community linkage arm: Any co-medications that are contraindicated or not recommended for concomitant use with glecaprevir-pibrentasvir
5. Poor venous access not allowing screening laboratory collection
6. Have any condition that the investigator considers a contraindication to study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

In prison treatment arm

No Intervention group

Description:

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 group

Description:

The rapid initiation group will receive HCV medication immediately upon release from prison/jail.

Treatment:

Drug: Glecaprevir/pibrentasvir

Community Linkage - Clinic-Based Initiation Arm

Active Comparator group

Description:

The group will receive medication after attending first ANCHOR clinic visit.

Treatment:

Drug: Glecaprevir/pibrentasvir

In prison - Retrospective Review

No Intervention group

Description:

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.