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

Phase 4

Withdrawn

• Conditions: HCV Infection
• Interventions: Drug: Glecaprevir/pibrentasvir

• Registration Number: NCT04235049
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-21
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-06
• Study Start: 2021-10-01
• Primary Completion: 2022-03-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Community Linkage - Rapid Initiation Arm	Glecaprevir/pibrentasvir	The rapid initiation group will receive HCV medication immediately upon release from prison/jail.
Community Linkage - Clinic-Based Initiation Arm	Glecaprevir/pibrentasvir	The group will receive medication after attending first ANCHOR clinic visit.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
OAT uptake Rates	12 months	Rates of OAT uptake in the CL arm (defined as completion of OAT induction)
Retrospective rates of SVR in the In prison arm	6 months after treatment	Absence of plasma HCV RNA levels 70 days or greater after completing direct acting antiviral therapy.
Treatment Initiation Rates	6 months	Rates of treatment initiation in the CL arm (defined as taking one dose of direct acting antiviral)
HCV Reinfection Rates	24 months	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)
Comparison between Rapid Initiation and Clinic-base Initiation	24 months	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.

Trial Locations

Locations (1)

Baltimore City Detention Center; 🇺🇸 Baltimore, Maryland, United States