Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04719338

Enrollment

Registered

2021-01-22

Start date

2021-03-01

Completion date

2021-10-01

Last updated

2022-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

occult HCV, direct antiviral drugs, haemodialysis

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.

Interventions

DIAGNOSTIC_TESTpresence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .

samples of peripheral blood from each patient into EDTA tube will be collected and tested for HCV RNA in peripheral blood mononuclear cells (PBMCs) .

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026