Nassim Kamar1, Florence Abravanel2, Patrick Behrendt3, Jörg Hofmann4, Georges Phillippe Pageaux5, Christelle Barbet6, Valérie Moal7, Lionel Couzi8, Thomas Horvatits9, Robert A De Man10, Elisabeth Cassuto11, Ahmed M Elsharkawy12, Annelies Riezebos-Brilman13, Anne Scemla14, Sophie Hillaire15, Mhairi C Donnelly16, Sylvie Radenne17, Johnny Sayegh18, Cyril Garrouste19, Jérôme Dumortier20, François Glowaki21, Marie Matignon22, Audrey Coilly23, Lucile Figueres24, Christiane Mousson25, Anne Minello26, Sébastien Dharancy27, Jean Philippe Rerolle28, Pascal Lebray29, Isabelle Etienne30, Peggy Perrin31, Mira Choi4, Olivier Marion2, Jacques Izopet2. 1. Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire (CHU) Rangueil, Institut National de la Santé et de la Recherche Médicale (INSERM) U1043, Institut Fédératif de Recherche Bio-médicale de Toulouse (IFR-BMT), University Paul Sabatier, Toulouse, France. 2. Department of Virology, INSERM U1043, IFR-BMT, University Paul Sabatier, Toulouse, France. 3. Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, and Institute of Experimental Virology, TWINCORE, Centre for Experimental and Clinical Infection Research, a joint venture between the Medical School Hannover and the Helmholtz Centre for Infection Research, German Centre for Infection Research, Hannover, Germany. 4. Charité Universitätsmedizin Berlin, Department of Nephrology and Intensive Care and Institute of Virology, Labor Berlin Charité-Vivantes-GmbH, Berlin, Germany. 5. Department of Hepatology, Saint Eloi Hospital, Montpellier, France. 6. Department of Nephrology and Clinical Immunology, Bretonneau Hospital, University Hospital, Tours, France. 7. Aix Marseille Université, Asistance Publique Hôpitaux de Marseille, Institut Pour la Recherche Pour le Développement, Microbes, Evolution, Phylogénie et Infection, Institut Hospitalo-Universitaire-Méditerranée Infection, Hôpital Conception, Centre de Néphrologie et Transplantation Rénale, Marseille, France. 8. Department of Nephrology and Transplantation, CHU Bordeaux, Bordeaux, France. 9. Department of Medicine I, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 10. Departments of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands. 11. Department of Nephrology and Transplantation, CHU Nice, France. 12. Liver Unit, University Hospitals Birmingham, Birmingham, United Kingdom. 13. Department of Medical Microbiology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands. 14. Service de néphrologie-transplantation, Hôpital Necker, Assitance publique- Hôpitaux de Paris (AP-HP), Paris et Université Paris Descartes, Paris, France. 15. Department of Hepatology, Hôpital Foch, Suresnes, France. 16. Department of Hepatology and Scottish Liver Transplant Unit, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom. 17. Department of Hepatology and Liver Transplantation, CHU de la Croix Rousse, Lyon, France. 18. Department of Nephrology and Transplantation, CHU Angers, Angers, France. 19. Department of Nephrology, CHU Clermont-Ferrand, Clermont-Ferrand, France. 20. Department of Hepatology, Edouard Herriot Hospital, CHU Lyon, Lyon, France. 21. Department of Nephrology, CHU Lille, Lille, France. 22. Assistance Publique-Hôpitaux de Paris, Nephrology and Renal Transplantation Department, Groupe Hospitalier Henri-Mondor/Albert-Chenevier, Université Paris-Est-Créteil, Département Hospitalo-Universitaire Virus-Immunité-Cancer, Institut Mondor de Recherche Biomédicale, Equipe 21, INSERM U 955, Créteil, France. 23. Centre Hépato-Biliaire, Hôpital Paul Brousse, AP-HP, INSERM U1193, Université Paris-Sud Paris-Saclay, Villejuif, France. 24. Department of Nephrology and Clinical Immunology, CHU Nantes, Nantes, France. 25. Department of Nephrology, CHU François Mitterrand, Dijon, France. 26. Department of Hepatogastroenterology and Digestive Oncology, CHU François Mitterrand, Dijon, France. 27. Hôpital Claude Huriez, Services Maladies de l'Appareil Digestif, INSERM Unité 995, Lille, France. 28. Department of Nephrology, CHU Limoges, Limoges, France. 29. Department of Hepatology, Pitié Salpétrière Hospital, Paris, France. 30. Department of Nephrology, CHU Rouen, Rouen, France. 31. Department of Nephrology, CHU Strasbourg, Strasbourg, France.
Abstract
BACKGROUND: Ribavirin is currently recommended for treating chronic hepatitis E virus (HEV) infection. This retrospective European multicenter study aimed to assess the sustained virological response (SVR) in a large cohort of solid organ transplant (SOT) recipients with chronic HEV infection treated with ribavirin monotherapy (N = 255), to identify the predictive factors for SVR, and to evaluate the impact of HEV RNA mutations on virological response. METHODS: Data from 255 SOT recipients with chronic HEV infection from 30 European centers were analyzed. Ribavirin was given at the median dose of 600 (range, 29-1200) mg/day (mean, 8.6 ± 3.6 mg/kg/day) for a median duration of 3 (range, 0.25-18) months. RESULTS: After a first course of ribavirin, the SVR rate was 81.2%. It increased to 89.8% when some patients were offered a second course of ribavirin. An increased lymphocyte count at the initiation of therapy was a predictive factor for SVR, while poor hematological tolerance of ribavirin requiring its dose reduction (28%) and blood transfusion (15.7%) were associated with more relapse after ribavirin cessation. Pretreatment HEV polymerase mutations and de novo mutations under ribavirin did not have a negative impact on HEV clearance. Anemia was the main adverse event. CONCLUSIONS: This large-scale retrospective study confirms that ribavirin is highly efficient for treating chronic HEV infection in SOT recipients and shows that the predominant HEV RNA polymerase mutations found in this study do not affect the rate of HEV clearance.This large-scale retrospective study that included 255 solid organ transplant recipients confirms that ribavirin is highly efficient for treating chronic hepatitis E virus (HEV) infection and shows that HEV RNA polymerase mutations do not play a role in HEV clearance.
BACKGROUND:Ribavirin is currently recommended for treating chronic hepatitis E virus (HEV) infection. This retrospective European multicenter study aimed to assess the sustained virological response (SVR) in a large cohort of solid organ transplant (SOT) recipients with chronic HEV infection treated with ribavirin monotherapy (N = 255), to identify the predictive factors for SVR, and to evaluate the impact of HEV RNA mutations on virological response. METHODS: Data from 255 SOT recipients with chronic HEV infection from 30 European centers were analyzed. Ribavirin was given at the median dose of 600 (range, 29-1200) mg/day (mean, 8.6 ± 3.6 mg/kg/day) for a median duration of 3 (range, 0.25-18) months. RESULTS: After a first course of ribavirin, the SVR rate was 81.2%. It increased to 89.8% when some patients were offered a second course of ribavirin. An increased lymphocyte count at the initiation of therapy was a predictive factor for SVR, while poor hematological tolerance of ribavirin requiring its dose reduction (28%) and blood transfusion (15.7%) were associated with more relapse after ribavirin cessation. Pretreatment HEV polymerase mutations and de novo mutations under ribavirin did not have a negative impact on HEV clearance. Anemia was the main adverse event. CONCLUSIONS: This large-scale retrospective study confirms that ribavirin is highly efficient for treating chronic HEV infection in SOT recipients and shows that the predominant HEV RNA polymerase mutations found in this study do not affect the rate of HEV clearance.This large-scale retrospective study that included 255 solid organ transplant recipients confirms that ribavirin is highly efficient for treating chronic hepatitis E virus (HEV) infection and shows that HEV RNA polymerase mutations do not play a role in HEV clearance.
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