HCV Reinfection in HD Patients Achieving SVR

Hemodialysis Complication Clinical Trial

Official title:

Risk of Hepatitis C Virus Reinfection in Hemodialysis Patients With Chronic Hepatitis C Achieving Sustained Virologic Response Following Antiviral Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732832
• Other study ID #: 202012090RINC
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: March 2024

Study information

• Verified date: February 2021
• Source: National Taiwan University Hospital
• Contact: Chen-Hua Liu, MD
• Phone: +886-223123456
• Email: jacque_liu[@]mail2000.com.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Among the hemodialysis units, the global incidence of HCV infection ranges from 1.2% to 2.9%. Data regarding the long-term risk of reinfection among hemodialysis patients achieving SVR are limited. To our best knowledge, only one study assessed the long-term negativity of serum HCV RNA in hemodialysis patients who achieved SVR after IFN-based therapies. With a median follow-up of 48 months following SVR, the life-time cumulative survival for HCV RNA negativity was 86% among the 121 participants who were on maintenance dialysis. Furthermore, the life-time cumulative survival for HCV RNA negativity was 95% among the 45 participants who underwent renal transplantation from HCV-negative donors. Because the literatures regarding the long-term follow-up of viral outcome, the patient numbers to be recruited are still limited, and all studies are focused on IFN-based treatment, we aim to assess the long-term risk of HCV reinfection in hemodialysis patients attaining SVR by IFN-based or IFN-free therapies.

Description:

Hepatitis C virus (HCV) infection is an important public health problem. Compared to the global prevalence of HCV infection to be around 1.0%, the prevalence of HCV infection in hemodialysis patients is around 10%. The high prevalence of HCV infection in hemodialysis patients receiving long-term renal replacement therapy may be reasoned by the nosocomial transmission in hemodialysis units. If chronic HCV infection is left untreated, the survival, hospitalization and the quality of life are significantly compromised in hemodialysis patients. In contrast, the survival is improved following successful treatment-induced HCV clearance Interferon (IFN)-based therapy is the treatment of choice for hemodialysis patients with HCV infection in earlier years. However, the treatment responses are far from ideal and the treatment-emergent adverse events (AEs) are frequently encountered, making the global treatment uptake rate by IFN-based therapies to be only 1.5%. Based on the excellent efficacy and safety, IFN-free direct acting antivirals (DAAs) have been the mainstay of therapy for HCV. Furthermore, the world health organization (WHO) has set the goal of global HCV elimination by 2030. The microelimination of HCV among hemodialysis patients is also listed as the prioritized target by WHO.

The updated definition of sustained virologic response (SVR) is the presence of serum undetectable HCV RNA level at week 12 after the stopping of antiviral therapy. However, the consensus in Taiwan mandates that hemodialysis patients who achieve SVR at off-therapy week 24 can be moved from HCV-segregated zone to cleat zone in hemodialysis unit, instead of the global definition of off-therapy week 12. The delay of bed-transfer from HCV-infective zone to clear zone might increase the risk of reinfection in hemodialysis patients achieving SVR. Therefore, we aim to assess the risk of short-term of HCV reinfection in hemodialysis patients achieving SVR at week 12 after antiviral therapy, which may be great relevance and importance for health policy making.

Among the hemodialysis units, the global incidence of HCV infection ranges from 1.2% to 2.9%. Data regarding the long-term risk of reinfection among hemodialysis patients achieving SVR are limited. To our best knowledge, only one study assessed the long-term negativity of serum HCV RNA in hemodialysis patients who achieved SVR after IFN-based therapies. With a median follow-up of 48 months following SVR, the life-time cumulative survival for HCV RNA negativity was 86% among the 121 participants who were on maintenance dialysis. Furthermore, the life-time cumulative survival for HCV RNA negativity was 95% among the 45 participants who underwent renal transplantation from HCV-negative donors. Because the literatures regarding the long-term follow-up of viral outcome, the patient numbers to be recruited are still limited, and all studies are focused on IFN-based treatment, we aim to assess the long-term risk of HCV reinfection in hemodialysis patients attaining SVR by IFN-based or IFN-free therapies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: March 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age old than 20 years old

• Patients receiving hemodialysis during interferon (IFN)-based or IFN-free antiviral therapy

• Patients achieving sustained virologic response (SVR), defined as undetectable serum HCV RNA at week 12 off-therapy

Exclusion Criteria:

• Poor access to sites for venipuncture

Related Conditions & MeSH terms

• Communicable Diseases
• Hemodialysis Complication
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus Infection
• Hepatitis C Virus Infection, Response to Therapy of
• Infection
• Virus Diseases

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Douliu
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei City Hospital, Ren-Ai Branch	Taipei
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative reinfection rate	Time-dependent accumulative proportion of participants with evidence of resurgence of HCV viremia from the time point of viral clearance after antiviral therapy to the time point of last follow-up	Through study completion, an average of 3 years