Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-05 @ 3:30 AM
Study NCT ID:
NCT02460133
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-23
First Post:
2015-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment
Sponsor:
Nova Scotia Health Authority
Organization:
Study Overview
Official Title:
Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot study is crucial to determining whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. It will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
Detailed Description:
Hepatitis C virus (HCV) is a blood-borne virus that causes both acute and chronic liver disease. Chronic HCV infection is associated with progressive liver disease and significant morbidity and mortality and represents a significant public health burden with approximately 150 million people infected worldwide. Until very recently, HCV treatment was extremely difficult for both clinicians and patients. Treatment strategies had debilitating side effects including dangerously low blood levels and clinical depression that often resulted in incomplete therapy and relatively infrequent cure (only 60-70% of individuals). In addition, the extended duration of therapy (up to one year) often precluded treatment for marginalized individuals with unstable life circumstances or intermittent incarceration.
Within the last 4 years, new direct acting antivirals (DAA) have been licensed for the treatment of HCV infection. These newly approved regimens are short (12 weeks), extremely safe, well tolerated and result in cure rates in excess of 90%.
HCV cure is defined as undetectable serum HCV viral load 12 weeks after finishing therapy. This is also termed 12 week sustained virologic response or SVR12.
In Canada, over 240,000 individuals have HCV, and the majority of new HCV infections occur through intravenous drug use. Many of these individuals encounter the federal and/or provincial corrections system at some point in their lifetime, and it is estimated that up to 80% of injection drug users (IVDU) practice needle sharing. Incarcerated individuals are a vulnerable, high risk population who are generally excluded from clinical studies and access to novel classes of antiviral therapies.
If all individuals were diagnosed, treated and cured, incident and chronic HCV infection within the incarcerated population would likely be greatly reduced (a type of harm reduction or treat to prevent strategy). Additionally, there may be an immunologic rationale for reduced rates of reinfection after viral cure with these therapies, and immune investigations in this study address this issue. Essentially, this study asks whether treatment of the majority of HCV positive individuals in a discrete population is harm reduction in and of itself. That is, individuals may have decreased susceptibility to HCV infection because of increased immunity and the population may see decreased reinfection rates because of reduced viral reservoir in the local community.
This novel pilot study is crucial to determine whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. This study will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
Within the last 4 years, new direct acting antivirals (DAA) have been licensed for the treatment of HCV infection. These newly approved regimens are short (12 weeks), extremely safe, well tolerated and result in cure rates in excess of 90%.
HCV cure is defined as undetectable serum HCV viral load 12 weeks after finishing therapy. This is also termed 12 week sustained virologic response or SVR12.
In Canada, over 240,000 individuals have HCV, and the majority of new HCV infections occur through intravenous drug use. Many of these individuals encounter the federal and/or provincial corrections system at some point in their lifetime, and it is estimated that up to 80% of injection drug users (IVDU) practice needle sharing. Incarcerated individuals are a vulnerable, high risk population who are generally excluded from clinical studies and access to novel classes of antiviral therapies.
If all individuals were diagnosed, treated and cured, incident and chronic HCV infection within the incarcerated population would likely be greatly reduced (a type of harm reduction or treat to prevent strategy). Additionally, there may be an immunologic rationale for reduced rates of reinfection after viral cure with these therapies, and immune investigations in this study address this issue. Essentially, this study asks whether treatment of the majority of HCV positive individuals in a discrete population is harm reduction in and of itself. That is, individuals may have decreased susceptibility to HCV infection because of increased immunity and the population may see decreased reinfection rates because of reduced viral reservoir in the local community.
This novel pilot study is crucial to determine whether treating individuals who are at high risk for transmission or re-infection will impact HCV reinfection rates. This study will establish the feasibility of DAA treatment in corrections facilities, as well as delineate the underlying immune basis of HCV cure and reinfection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: