Surveillance of HCV in Uremics and Linking to Medical Care
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Observational

Summary: 
      HCV remains to prevail in the uremic patients under hemodialysis. The comprehensive
      surveillance in the risk population facilitates the link to care for HCV eradication.
    

Detailed description: 
      1. Taiwan has the leading prevalence and incidence of end-stage renal disease (ESRD)
           worldwide. Uremic patients on maintenance hemodialysis (HD) are at great risk for
           hepatitis C virus (HCV) infection. The prevalence and annual incidence of HCV infection
           in ESRD patients undergoing hemodialysis have been reported to be 10%-59% and 0.2%-6.2%,
           respectively.

        2. HCV-related morbidities and mortality remain the major disease burden in the ESRD
           population. Uremic patients with HCV infection are associated with higher risk of excess
           risk of cardiovascular disease, hospitalization, worse quality of life, and mortality,
           and have more profound anemia compared to those without HCV infection..

        3. Imperatively, uremic patients remain at high risk of HCV new- or re-infection in the
           hemodialysis units.

        4. The investigators have performed a surveillance for prevalence of viral hepatitis in a
           collaborative group of Nephrologists and Hepatologists, the FORMOSA-LIKE group, which
           showed that the proportion of anti-HCV seropositivity in uremic patients is 15-19 % with
           the viremic rate of ~75% in Southern Taiwan in 2012. However, the update seroprevalence
           and disease severity of HCV infection among the uremic patients in the era of DAA in
           Taiwan is unknown. The current study aims to fully execute the surveillance program
           among the uremic population

        5. Participants with HCV infection will be directly linked to medical care without gap. The
           concept of micro-elimination in the high risk environment would help to facilitate WHO
           goal of HCV elimination by 2030.

        6. Understanding the potential drug-drug interaction (DDI) between directly acting
           antivirals (DAA) and co-medications for co-morbidities among uremic patients under
           maintenance hemodialysis would be helpful for decision-making when linking to care.

        7. Comprehensive surveillance and link-to-care among hemodialysis units might have great
           impact on the improvement of both liver-related (biochemical and virological responses,
           and hepatic fibrosis regression) and non-liver related outcomes (monthly erythropoietin
           requirement and quality of life), and the transfer rate of clean zoning among
           HCV-viremic patients.

      All uremic participants will be tested for anti-HCV antibody. HCV virology including viral
      loads (and genotypes if RNA seropositivity) will be further tested in patients with anti-HCV
      seropositivity. All infected subjects will be evaluated for the liver fibrosis by
      non-invasive methods including fibroscan, FIB-4 and APRI and Serum WFA(+) -M2BP. All
      participants with chronic hepatitis C infection will be directly referred to the
      collaborative Hepatology Departments in one medical center and 5 regional core hospitals for
      HCV treatment. The outcome of HCV-related diseases, in terms of proportion of HCV
      micro-elimination in HD facilities, liver-related outcomes (biochemistry improvement [ ALT
      and AFP decline], sustained virological response rate, and hepatic fibrosis regression) and
      non-liver related outcomes [monthly erythropoietin requirement, and quality of life [SF36,
      HCV-CLDQ] ) will be evaluated 2 years after executing link-to-care strategy.

      Year 1: Universal screen, confirmative determination of HCV viremia, genotyping and disease
      staging, education and link-to-care for HCV treatment in FORMOSA-LIKE collaborative alliances
      Year 2,3: Re-evaluate liver and non-liver related outcomes, and rate of HCV clean zoning
      among hemodialysis units.
    

Intervention name(s): blood test, noninvasive test for liver fibrosis
Intervention type(s): Procedure
Intervention description(s): blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The FORMOSA-LIKE group is a collaborative alliance of Hepatology and Nephrology in Taiwan.
        It contains around 2000 uremic patients with maintenance hemodialysis in 21 hemodialysis
        units (one medical center, 4 regional core hospitals and 16 regional clinics). The current
        study plan to launch a universal surveillance of HCV in the cohort.