HCV Reinfection in HD Patients Achieving SVR
Risk of Hepatitis C Virus Reinfection in Hemodialysis Patients With Chronic Hepatitis C Achieving Sustained Virologic Response Following Antiviral Therapy
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Chen-Hua Liu, MD
- 전화번호: 63572 +886-223123456
- 이메일: jacque_liu@mail2000.com.tw
연구 장소
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Douliu, 대만, 640
- 모병
- National Taiwan University Hospital, Yun-Lin branch
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연락하다:
- Chen-Hua Liu, MD
- 전화번호: +886-972651880
- 이메일: jacque_liu@mail2000.com.tw
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Taichung, 대만, 40705
- 모병
- Taichung Veterans General Hospital
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연락하다:
- Sheng-Shun Yang, MD
- 전화번호: +886423592525
- 이메일: yansh@vghtc.gov.tw
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Taichung, 대만, 40447
- 모병
- China Medical University Hospital
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연락하다:
- Cheng-Yuan Peng, MD
- 전화번호: +886422052121
- 이메일: cypeng@mail.cmuh.org.tw
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital
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연락하다:
- Chen-Hua Liu, MD
- 전화번호: 63572 +886-223123456
- 이메일: jacque_liu@mail2000.com.tw
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Taipei, 대만
- 모병
- Tri-Service General Hospital
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연락하다:
- Yu-Lueng Shih, MD
- 전화번호: +886287923311
- 이메일: albreb@ms28.hinet.net
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Taipei, 대만, 110
- 모병
- Taipei Medical University Hospital
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연락하다:
- Wei-Yu Kao, MD
- 전화번호: +886227372181
- 이메일: 121021@tmuh.org.tw
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Taipei, 대만, 10629
- 모병
- Taipei City Hospital, Ren-Ai Branch
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연락하다:
- Chih-Lin Lin, MD
- 전화번호: +886227093600
- 이메일: DAB53@tpech.gov.tw
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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누적 재감염률
기간: 학업 수료까지 평균 3년
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항바이러스 요법 후 바이러스 제거 시점부터 마지막 추적 시점까지 HCV 바이러스 혈증의 재발 증거가 있는 참가자의 시간에 따른 누적 비율
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학업 수료까지 평균 3년
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chen-Hua Liu, MD, National Taiwan University Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202012090RINC
약물 및 장치 정보, 연구 문서
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