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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.
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.](streamdown:incomplete-link)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood test, noninvasive test for liver fibrosis | Procedure | blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis |
| Measure | Description | Time Frame |
|---|---|---|
| HCV prevalence | To explore the current prevalence rate of hepatitis C virus (HCV) infection in uremic patients under maintenance hemodialysis in Taiwan | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| liver fibrosis in HCV uremic patients | To identify the severity of liver diseases in the uremic patients under maintenance hemodialysis by transient elastography | 36 months |
| Number of participants with potential drug-drug interaction with DAA |
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Inclusion Criteria:
all uremic patients and medical staffs in the hemodialysis centers
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Lung Yu, MD.,PhD. | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | 807 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38046041 | Derived | Huang CF, Dai CY, Wang CW, Liang PC, Wei YJ, Tsai PC, Jang TY, Hsu PY, Jia-Jung Lee, Niu SW, Huang JC, Yeh ML, Huang CI, Hsieh MY, Lin YH, Chen SC, Chiu YW, Huang JF, Chang JM, Hwang SJ, Chuang WL, Yu ML; FORMOSA-LIKE investigators. Therapy as prevention toward HCV elimination in maintenance hemodialysis: a multi-center, prospective cohort study. Clin Kidney J. 2023 Jun 14;16(12):2429-2436. doi: 10.1093/ckj/sfad138. eCollection 2023 Dec. | |
| 33533547 |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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To evaluate the patient number of potential drug-drug interactions (DDI) of co-medications with DAA by checking-up through the website, https://www.hep-druginteractions.org/
| 36 months |
| Number of participants with hepatic outcome after HCV eradication | incidence of HCC and fibrosis regression by Fibroscan after link-to-care to antiviral therapy | 36 months |
| Number of participants with extra-hepatic outcome after HCV eradication | patients with improvement of quality of life by questionnaire SF36 and HCV-CLDQ | 36 months |
| Derived |
| Wei YJ, Hsu PY, Lee JJ, Niu SW, Huang JC, Hsu CT, Jang TY, Yeh ML, Huang CI, Liang PC, Lin YH, Hsieh MY, Hsieh MH, Chen SC, Dai CY, Lin ZY, Chen SC, Huang JF, Chang JM, Hwang SJ, Chuang WL, Huang CF, Chiu YW, Yu ML. Evolutionary seroepidemiology of viral hepatitis and the gap in hepatitis C care cascades among uraemic patients receiving haemodialysis in Taiwan-the Formosa-Like Group. J Viral Hepat. 2021 May;28(5):719-727. doi: 10.1111/jvh.13477. Epub 2021 Feb 13. |
| 33303567 | Derived | Yu ML, Huang CF, Wei YJ, Lin WY, Lin YH, Hsu PY, Hsu CT, Liu TW, Lee JJ, Niu SW, Huang JC, Hung TS, Yeh ML, Huang CI, Liang PC, Hsieh MY, Chen SC, Huang JF, Chang JM, Chiu YW, Dai CY, Hwang SJ, Chuang WL; FORMOSA-LIKE investigators. Establishment of an outreach, grouping healthcare system to achieve microelimination of HCV for uremic patients in haemodialysis centres (ERASE-C). Gut. 2021 Dec;70(12):2349-2358. doi: 10.1136/gutjnl-2020-323277. Epub 2020 Dec 10. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |