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.