HCV Reinfection in HD Patients Achieving SVR

NCT ID: NCT04732832

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-03-31

Brief 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.

Detailed 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.

Conditions

Hepatitis C Virus Infection; Hepatitis C Virus Infection, Response to Therapy of; Hemodialysis Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen-Hua Liu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital, Yun-Lin Branch

Douliu, , Taiwan

Site Status: RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status: RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Taipei City Hospital, Ren-Ai Branch

Taipei, , Taiwan

Site Status: RECRUITING

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Tri-Service General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chen-Hua Liu, MD

Role: CONTACT

jacque_liu@mail2000.com.tw

+886-223123456 ext. 63572

Facility Contacts

Chen-Hua Liu, MD

Role: primary

jacque_liu@mail2000.com.tw

+886-972651880

Cheng-Yuan Peng, MD

Role: primary

cypeng@mail.cmuh.org.tw

+886422052121

Sheng-Shun Yang, MD

Role: primary

yansh@vghtc.gov.tw

+886423592525

Chen-Hua Liu, MD

Role: primary

jacque_liu@mail2000.com.tw

+886-223123456 ext. 63572

Chih-Lin Lin, MD

Role: primary

DAB53@tpech.gov.tw

+886227093600

Wei-Yu Kao, MD

Role: primary

121021@tmuh.org.tw

+886227372181

Yu-Lueng Shih, MD

Role: primary

albreb@ms28.hinet.net

+886287923311

Other Identifiers

202012090RINC

Identifier Type: -

Identifier Source: org_study_id