Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

Study Overview
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Brief Summary
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This research aims to evaluate the prevalence and predictors of Occult HCV among hemodialysis (HD) patients who achieved 24 weeks sustained virological response (SVR) after treatment with direct-acting antiviral agents (DAA) by detection of viral RNA in their peripheral blood mononuclear cells.

Detailed Description
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In maintenance hemodialysis (MHD) patients, hepatitis C virus (HCV) infection is common and may be associated with poor clinical outcomes. A lot of treatment options for HCV have rapidly evolved over the past 5 years and various treatment choices for patients with advanced CKD are currently available.1 The reappearance of HCV infection months or years after sustained virologic response (SVR) may be due to the persistence of HCV in tissue cells in spite of being undetected in serum. This situation is known as occult hepatitis C infection (OCI).2 OCI is now a challenging entity in the field of post hepatitis management and follow-up. OCI is described when HCV-RNA is detectable in liver and/or peripheral blood mononuclear cells (PBMCs) in patients with undetectable serum HCV-RNA. To our knowledge , this is the first research to issue this problem in dialysis patients after treatment with direct acting antiviral drugs.

Official Title
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Occult Hepatitis C Virus Infection In Hemodialysis Patients Who Achieved A Sustained Virological Response To Directly Acting Antiviral Drugs: Is It A Concern ?

Conditions
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Hepatitis C

Intervention / Treatment
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* Diagnostic Test: presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients on regular hemodialysis treatment for more than 6 months. Achieved sustained virological response 24 weeks after the end of treatment with directly acting antiviral drugs (DAADs). Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: This research is a cross sectional study. Target population: thirty patients with end-stage renal disease (ESRD) receiving hemodialysis treatment from different dialysis centers in Alexandria will be enrolled in the study after achieving sustained virological response 24 weeks after the end of treatment with directly acting antiviral drugs (DAADs).will be screened for the presence of occult HCV infection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants<br>Immediately after confirmation of 24 weeks SVR after the end of treatment, we will collect samples of peripheral blood from each patient into EDTA tube and test for HCV RNA in peripheral blood mononuclear cells (PBMCs) . All patients included in this study will be subjected to full history taking and thorough clinical examination. The initial pre treatment data of the patients will be revised including body mass index (BMI), pre treatment status (naïve,experienced), pretreatment viral load by sensitive real-time HCV PCR technique, liver function tests, complete blood count, prothrombin time, international normalized ratio , Child-Pugh score, MELD score and FIB-4 score . | Diagnostic Test: presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .<br>* samples of peripheral blood from each patient into EDTA tube will be collected and tested for HCV RNA in peripheral blood mononuclear cells (PBMCs) .<br>* Other names: occult HCV infection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occult HCV infection | By assessing presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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occult HCV, direct antiviral drugs, haemodialysis