Occult HCV Infection After DAAD Treatment in Haemodialysis Patients

Hepatitis C Clinical Trial

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 ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04719338
• Other study ID #: occult HCV in dialysis
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Diagnostic Test:
• presence 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) .

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Maduell F, Belmar L, Ugalde J, Laguno M, Martínez-Rebollar M, Ojeda R, Arias M, Rodas L, Rossi F, Llovet LP, González LN, Mallolas J, Londoño 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. — View 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. — View Citation

Outcome

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