Eliminating Hepatitis C Virus

Mount Sinai Health System

Status

Completed

Conditions

Type2 Diabetes

Hepatitis C

HIV

Study type

Observational

Funder types

Other

Identifiers

NCT03401697

GCO 17-1070

Details and patient eligibility

About

Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection

18 years of age or older
HCV RNA positive
Any HCV genotype
Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count > 100, and an HIV viral load < 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count > 350
Expected life expectancy sufficient to receive a benefit from HCV cure
No conditions that are contraindications for the use of HCV medications

Inclusion criteria for HCV treatment in patients with type 2 diabetes

18 years of age or older
HCV RNA positive
Any HCV genotype
Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
Expected life expectancy sufficient to receive a benefit from HCV cure

Exclusion criteria