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

NCT04235049 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: HP-00088498
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HCV Infection

Keywords

HCV infection; Incarcerated individuals

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Retrospective rates of SVR in the In prison arm

  6 months after treatment

• Treatment Initiation Rates

  6 months

• OAT uptake Rates

  12 months

• HCV Reinfection Rates

  24 months

• Comparison between Rapid Initiation and Clinic-base Initiation

  24 months

Study Arms (4)

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.

Drug: Glecaprevir/pibrentasvir

Community Linkage - Clinic-Based Initiation Arm

ACTIVE COMPARATOR

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

Drug: Glecaprevir/pibrentasvir

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.

Interventions

Glecaprevir/pibrentasvir DRUG

Treatment for HCV Infection

Community Linkage - Clinic-Based Initiation Arm; Community Linkage - Rapid Initiation Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Merck Sharp & Dohme LLC: collaborator
• Maryland Department of Public Safety and Correctional Services: collaborator

Study Sites (1)

Baltimore City Detention Center

Baltimore, Maryland, 21202, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Elana Rosenthal, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 21, 2020
• Study Start: October 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: October 30, 2024
• Last Updated: May 6, 2021

Record last verified: 2021-04

Locations

US (1)