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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: HCV Infection
• Intervention / Treatment: Drug: Glecaprevir/pibrentasvir

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Baltimore City Detention Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: In prison treatment arm; 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; The rapid initiation group will receive HCV medication immediately upon release from prison/jail.	Drug: Glecaprevir/pibrentasvir; Treatment for HCV Infection
Active Comparator: Community Linkage - Clinic-Based Initiation Arm; The group will receive medication after attending first ANCHOR clinic visit.	Drug: Glecaprevir/pibrentasvir; Treatment for HCV Infection
No Intervention: In prison - Retrospective Review; 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?

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

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: Merck Sharp & Dohme LLC; Maryland Department of Public Safety and Correctional Services
• Investigators: Principal Investigator: Elana Rosenthal, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): October 30, 2024

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: HCV infection; Incarcerated individuals
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: HP-00088498

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes