Clinical trial NCT03018353: Curing HCV in Incarcerated Patients
Official title: Curing HCV in Incarcerated Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
Jail
Patient Navigation
Incarcerated Population
HCV
Sofosbuvir/Velpatasvir
Hepatitis C
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: University of California, San Francisco
name: San Francisco Study Center
name: Gilead Sciences
First posted: 2017-01-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City \& County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).

Detailed description: Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will be conducted in the San Francisco County Jails. Jail settings can provide an optimal opportunity to screen for HCV, initiate curative treatment, and link patients to community HCV providers to complete their treatment. This demonstration project will be funded by the Gilead's Investigator Sponsored Research. The purpose is to assess the feasibility of treating inmates with the FDA approved combination oral treatment, sofosbuvir/velpatasvir, Epclusa®. The San Francisco Department of Public Health's Jail Health Services will treat 100 patients. Intensive patient navigators will be an essential component for treatment to ensure medication adherence and achieve SVR for those who are discharged from jail prior to HCV treatment completion. Navigators will provide short-term case management services by linking patients to medical and social support services. This demonstration project will be facilitated by the Jail Health Services' HIV \& Integrated Services (formerly Forensic AIDS Project).

Eligibility criteria: Inclusion Criteria:

* a detectable HCV viral load
* no medical contraindications to treatment, including limited life expectancy of less than 12-months due to non-liver related comorbid conditions or renal failure with creatinine clearance of \< 30 mL/min.
* Must start HCV treatment while detained
* HIV positive or negative status
* HBV positive or negative status
* treatment-naïve or experienced
* with or without cirrhosis

Exclusion Criteria:

* a limited life expectancy of less than 12-months due to non-liver related comorbid conditions
* current or history of decompensated cirrhosis, defined as presence of ascites, hepatic encephalopathy, or variceal bleeding within the past 6 months.
* severe renal impairment defined as creatinine clearance of \< 30 mL/min or end stage renal disease (ESRD) on hemodialysis
* pregnant

Primary outcomes:
measure: SVR12 of 70% or greater
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Jail Health Services
state: California
Study officials:
References: