Curing HCV in Incarcerated Patients

Phase 4

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Patients receiving Sof/Vel (Epclusa) and Navigation services

• Registration Number: NCT03018353
• Lead Sponsor: San Francisco Department of Public Health

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).

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-12
• Study Start: 2017-03-05
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-06-01
• Primary Completion: 2018-03-04
• Study Completion: 2018-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Navigation services with sof/vel therapy	Patients receiving Sof/Vel (Epclusa) and Navigation services	This a single group demonstration project in which, patients are treated with the FDA-approved drug, Sofosbuvir/Velpatasvir (Epclusa). If a patients is released during their treatment regimen, they will receive patient navigation services to continue their care and treatment in the community.

Primary Outcome Measures

Name	Time	Method
SVR12 of 70% or greater	12 months	The primary objective is to implement a feasible HCV treatment program in an urban jail setting, City \& County of San Francisco, over a 12 month period, with demonstration of a SVR12 of 70% or greater among inmates who initiates HCV treatment

Trial Locations

Locations (1)

Jail Health Services; 🇺🇸 San Francisco, California, United States