Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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

Other names: occult HCV infection

Primary outcomes

Occult HCV infection

Time frame: 6 months

By assessing presence of HCV RNA in peripheral blood mononuclear cells (PBMCs)

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Jan 22, 2021
Registry last updated: Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed