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Hepatitis C elimination in the Netherlands (CELINE): study protocol for nationwide retrieval of lost to follow-up patients with chronic hepatitis C
  1. Cas J Isfordink1,2,
  2. Sylvia M Brakenhoff3,
  3. Marleen van Dijk4,
  4. Marc van der Valk2,
  5. Rob J de Knegt3,
  6. Joop E Arends5,
  7. Joost PH Drenth4
  8. on behalf of the HepNed study group
  1. 1Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, the Netherlands
  2. 2Division of Infectious Diseases, Amsterdam Infection & Immunity Institute Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
  3. 3Department of Gastroenterology and Hepatology, Erasmus MC University Medical Centre, Rotterdam, the Netherlands
  4. 4Department of Gastroenterology and Hepatology, Radboud University Medical Centre, Nijmegen, the Netherlands
  5. 5Department of Infectious Diseases, University Medical Centre Utrecht, Utrecht, the Netherlands
  1. Correspondence to Marleen van Dijk; marleen.vandijk{at}radboudumc.nl

Abstract

Background The Netherlands has a low hepatitis C virus (HCV) prevalence, estimated at 0.16%. Previous studies have shown that up to 30% of the diagnosed HCV population in the Netherlands has been lost to follow-up (LTFU). Retrieval of these patients could halt progression of liver disease in infected patients, reduce the number of infected individuals and limit HCV transmission. Several regional Dutch retrieval projects have already been executed, which demonstrated that retrieval is feasible. Therefore, we initiated a nationwide retrieval project, aiming to achieve microelimination in previously diagnosed but LTFU patients with chronic HCV through retrieval.

Methods Laboratory records will be used to identify possible patients with chronic hepatitis C, defined as either a positive most recent HCV RNA or positive HCV antibodies without known RNA result. Reviewing patient records and obtaining current contact information from municipality databases will identify LTFU patients who are eligible for retrieval. These patients will be invited for outpatient clinic care. The primary outcome of the study is the total number of LTFU patients who have been successfully linked to care.

Discussion Hepatitis C ELimination In the NEtherlands (CELINE) is within the remit of WHO elimination targets and the Dutch National Hepatitis Plan. The methodology of CELINE is based on previously conducted regional retrieval projects and is designed to overcome some of their limitations. After ethical approval was obtained in 2018, the first centre initiated retrieval in 2018 and the project is expected to finish in 2021.

Trial registration number NCT04208035.

  • hepatitis C
  • HCV
  • health service research
  • antiviral therapy
  • infectious disease
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Footnotes

  • Twitter @MarleenvanDijk_, @mvdvalk, @jooparends, @joostphdrenth

  • Contributors All authors participated in design and execution of the study. CJI, SMB and MvD wrote the manuscript. MvdV, RJdK, JEA, JPHD, JS, BvH, DB and HB critically reviewed the manuscript.

  • Funding CELINE is supported with an unrestricted grant from Gilead Sciences.

  • Disclaimer Gilead Sciences does not have any role in study design, data collection, management, analysis and/or interpretation.

  • Competing interests CJI, SMB and MvD have no conflicts of interest. MvdV declares that the Amsterdam Infection & Immunity Institute Amsterdam UMC, on behalf of MvdV, received fees for participation in advisory boards of Abbvie, Gilead, Johnson & Johnson, Merck Sharp & Dohme (MSD), and ViiV and received independent research grants from Abbvie, Johnson & Johnson, Gilead, and MSD. RJdK declares that the Erasmus University Medical Centre, on behalf of RJdK, received honoraria for consulting/speaking from Gilead, Janssen-Cilag, Bristol-Myers Squibb (BMS), Abbvie, MSD, Roche, and Norgine and received research grants from Gilead, Janssen-Cilag, BMS, and Roche. JEA declares that the University Medical Centre Utrecht, on behalf of JEA, received honoraria for participation in advisory boards of Gilead, Janssen-Cilag, BMS, Abbvie, MSD, and ViiV and received research grants from BMS, Abbvie, and ViiV. JPHD declares that the Radboudumc, on behalf of JPHD, received honoraria or research grants from Novartis, Ipsen, Otsuka, Abbvie, and Gilead. JPHD served as consultant for Gilead and Abbvie, and in the last two years has been member of advisory boards of Otsuka, Norgine Gilead, BMS, Janssen, and Abbvie. JS participated in advisory boards of Gilead and received research grants from Gilead and Abbvie. SW has received honoraria for consulting/speaking from Gilead, Janssen-Cilag, BMS, and Roche, participated in advisory boards of Gilead, BMS, and Abbvie and received research grants from Gilead, Janssen-Cilag BMS, Abbvie, MSD, and Roche. BvH participated in advisory boards of Janssen-Cilag, BMS, Abbvie, MSD, and Norgine and received a research grant from Zambon Pharma. DP has no conflicts of interest to declare. DB has received honoraria for consulting/speaking from MSD, participated in advisory boards of MSD and received research grants from Gilead, Janssen-Cilag, BMS, MSD, and Roche. HB has participated in advisory boards of Gilead. KvE participated in advisory boards of Gilead, Janssen-Cilag, BMS, Abbvie, and MSD and received research grants from Gilead and Janssen-Cilag.

  • Patient consent for publication Not required.

  • Ethics approval Formal ethical approval was waived in 2018 by the Research Ethics Committee Arnhem-Nijmegen as they ruled that CELINE does not fall within the Medical Research Involving Human Subjects Act. Local approval is obtained in each participating centre.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Future data are available upon reasonable request from the corresponding author.

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