HCV Infection
Conditions
Keywords
HCV infection, Incarcerated individuals
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.
Interventions
Treatment for HCV Infection
Sponsors
Merck Sharp & Dohme LLC
Maryland Department of Public Safety and Correctional Services
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| OAT uptake Rates | 12 months | Rates of OAT uptake in the CL arm (defined as completion of OAT induction) |
| 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. |
Countries
United States
Outcome results
None listed