Eliminating Hepatitis C Virus

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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HIV, Hepatitis C, Type2 Diabetes

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV/HCV Co-infected<br>Patients with HIV/HCV co-infection | |
| Type 2 Diabetes<br>Patients with Type 2 Diabetes | |

What is the study measuring?
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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 |