Eliminating Hepatitis C Virus

Curing HCV at Mount Sinai in Patients at High Risk for Disease Progression: HIV/HCV Co-infection and Type 2 Diabetes, New Solutions to the Challenge of Eliminating HCV

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis C; HIV; Type2 Diabetes

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who receive care at Mount Sinai and candidates for HCV testing or HCV treatment and co-located at non-hepatology care sites.

Description

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:

• No conditions that are contraindications for the use of HCV medications

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV/HCV Co-infected; Patients with HIV/HCV co-infection
Type 2 Diabetes; Patients with Type 2 Diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Number of Patients with sCD163 above the upper limit of normal	Change in the Number of Patients with sCD163 above the upper limit of normal at 3 years from baseline	baseline and 3 years
Number of Type 2 Diabetes patients that initiate HCV treatment	The number of patients that initiate HCV treatment per month per patient navigator.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sCD163	blood sample for sC163, a marker of systemic inflammation.	3 years
Percentage of patients in need of repeated re-treatment	The percentage of patients in need of repeated re-treatment whose quasispecies analysis indicates that re-infection is the likely cause of recurrent HCV viremia. If such patients are identified, they will be referred for risk reduction counseling.	3 years
HOMA-IR	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.	3 years
Number of resistance associated variant (RAV)	Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected	3 years
FIB-4 score	The FIB-4 score of HCV positive patients with type 2 diabetes. The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests that help to estimate the amount of scarring in the liver. This score has been studied in liver disease due to Hepatitis C and NASH. Formula : ( Age x AST ) / ( Platelets x ( sqr ( ALT )	3 years
HCV cure rate	The HCV cure rate among patients with type 2 diabetes	3 years

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Andrea D. Branch, PhD, Icahn School of Medicine at Mount Sinia

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2018
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 9, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2021
• Last Update Submitted That Met QC Criteria: March 23, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Endocrine System Diseases; Diabetes Mellitus; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Diabetes Mellitus, Type 2; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: GCO 17-1070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Direct outreach to providers (giving them the names of their patients who are candidates for treatment)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No