Eliminating Hepatitis C Virus

Completed

• Conditions: Hepatitis C; Type2 Diabetes; HIV

• Registration Number: NCT03401697
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-09
• Study First Submitted QC: 2018-01-16
• Study First Posted: 2018-01-17
• Study Start: 2018-01-23
• Status Verified: 2021-03
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
sCD163	3 years	blood sample for sC163, a marker of systemic inflammation.
Percentage of patients in need of repeated re-treatment	3 years	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.
HOMA-IR	3 years	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.
FIB-4 score	3 years	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 )
Number of resistance associated variant (RAV)	3 years	Resistance associated variant (RAV) testing from up to 50 patients who fail treatment or become re-infected
HCV cure rate	3 years	The HCV cure rate among patients with type 2 diabetes

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States