Clinical trial NCT04719338: Occult HCV Infection After DAAD Treatment in Haemodialysis Patients
Official title: Occult Hepatitis C Virus Infection In Hemodialysis Patients Who Achieved A Sustained Virological Response To Directly Acting Antiviral Drugs: Is It A Concern ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Keywords: occult HCV, direct antiviral drugs, haemodialysis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Occult HCV infection
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University
Study officials:
affiliation: Lecturer of Nephrology & Internal Medicine, Faculty of medicine, Alexandria University
name: Mohamed Mamdouh Elsayed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: fellow of Clinical and Chemical Pathology Department, Alexandria University Hospitals
name: Shady F Abouelnaga, MD
role: STUDY_CHAIR
affiliation: Lecturer of Hepatolgy and Internal Medicine Department, Faculty of Medicine, Alexandria University
name: Hend N Abd Elmoteleub, MD
role: STUDY_CHAIR
References:
citation: Maduell F, Belmar L, Ugalde J, Laguno M, Martinez-Rebollar M, Ojeda R, Arias M, Rodas L, Rossi F, Llovet LP, Gonzalez LN, Mallolas J, Londono MC. Elimination of hepatitis C virus infection from a hemodialysis unit and impact of treatment on the control of anemia. Gastroenterol Hepatol. 2019 Mar;42(3):164-170. doi: 10.1016/j.gastrohep.2018.07.015. Epub 2018 Oct 4. English, Spanish.
citation: Naghdi R, Ranjbar M, Bokharaei-Salim F, Keyvani H, Savaj S, Ossareh S, Shirali A, Mohammad-Alizadeh AH. Occult Hepatitis C Infection Among Hemodialysis Patients: A Prevalence Study. Ann Hepatol. 2017 Jul-Aug;16(4):510-513. doi: 10.5604/01.3001.0010.0277.