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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Chen-Hua Liu, MD
- Telefonnummer: 63572 +886-223123456
- E-post: jacque_liu@mail2000.com.tw
Studiesteder
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Douliu, Taiwan, 640
- Rekruttering
- National Taiwan University Hospital, Yun-Lin branch
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Ta kontakt med:
- Chen-Hua Liu, MD
- Telefonnummer: +886-972651880
- E-post: jacque_liu@mail2000.com.tw
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Taichung, Taiwan, 40705
- Rekruttering
- Taichung Veterans General Hospital
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Ta kontakt med:
- Sheng-Shun Yang, MD
- Telefonnummer: +886423592525
- E-post: yansh@vghtc.gov.tw
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Taichung, Taiwan, 40447
- Rekruttering
- China Medical University Hospital
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Ta kontakt med:
- Cheng-Yuan Peng, MD
- Telefonnummer: +886422052121
- E-post: cypeng@mail.cmuh.org.tw
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Taipei, Taiwan, 100
- Rekruttering
- National Taiwan University Hospital
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Ta kontakt med:
- Chen-Hua Liu, MD
- Telefonnummer: 63572 +886-223123456
- E-post: jacque_liu@mail2000.com.tw
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Taipei, Taiwan
- Rekruttering
- Tri-Service General Hospital
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Ta kontakt med:
- Yu-Lueng Shih, MD
- Telefonnummer: +886287923311
- E-post: albreb@ms28.hinet.net
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Taipei, Taiwan, 110
- Rekruttering
- Taipei Medical University Hospital
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Ta kontakt med:
- Wei-Yu Kao, MD
- Telefonnummer: +886227372181
- E-post: 121021@tmuh.org.tw
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Taipei, Taiwan, 10629
- Rekruttering
- Taipei City Hospital, Ren-Ai Branch
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Ta kontakt med:
- Chih-Lin Lin, MD
- Telefonnummer: +886227093600
- E-post: DAB53@tpech.gov.tw
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Kumulativ reinfeksjonsrate
Tidsramme: Gjennom studiegjennomføring i snitt 3 år
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Tidsavhengig akkumulert andel av deltakere med bevis på gjenoppblomstring av HCV-viremi fra tidspunktet for virusclearing etter antiviral terapi til tidspunktet for siste oppfølging
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Gjennom studiegjennomføring i snitt 3 år
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Chen-Hua Liu, MD, National Taiwan University Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Patologiske prosesser
- RNA-virusinfeksjoner
- Blodbårne infeksjoner
- Sykdomsattributter
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Enterovirusinfeksjoner
- Picornaviridae-infeksjoner
- Tilbakefall
- Infeksjoner
- Smittsomme sykdommer
- Hepatitt
- Hepatitt A-virus
- Hepatitt C
- Virussykdommer
- Reinfeksjon
Andre studie-ID-numre
- 202012090RINC
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