Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

Not Applicable

Completed

• Conditions: Hepatitis C
• Interventions: Diagnostic Test: presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .

• Registration Number: NCT04719338
• Lead Sponsor: Alexandria University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-03-01
• Primary Completion: 2021-08-01
• Study Completion: 2021-10-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
participants	presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .	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 .

Primary Outcome Measures

Name	Time	Method
Occult HCV infection	6 months	By assessing presence of HCV RNA in peripheral blood mononuclear cells (PBMCs)

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University; 🇪🇬 Alexandria, Egypt