Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732832
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2021-01-26
Brief Title:
HCV Reinfection in HD Patients Achieving SVR
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Risk of Hepatitis C Virus Reinfection in Hemodialysis Patients With Chronic Hepatitis C Achieving Sustained Virologic Response Following Antiviral Therapy
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Among the hemodialysis units the global incidence of HCV infection ranges from 12 to 29 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 10 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 15 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 12 to 29 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
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 12 to 29 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None