Curing HCV in Incarcerated Patients

• Status: Unknown status
• Trial end date: 2018-06-04
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Francisco Department of Public Health
• Collaborators: Gilead Sciences; Gilead, Inc. Investigator Sponsored Research; San Francisco Study Center; University of California, San Francisco
• Treatments: Sofosbuvir-velpatasvir drug combination

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