Malgorzata Mikulska1, Nina Knelange2, Laura Ambra Nicolini3, Gloria Tridello4, Stella Santarone5, Paolo Di Bartolomeo5, Rafael de la Camara6, Clara Cuéllar7, Andrea Velardi8, Katia Perruccio9, Per Ljungman10, Jan Zaucha11, Agnieszka Piekarska11, Grzegorz Basak12, Ewa Karakulska-Prystupiuk13, Emanuele Angelucci14, Fabio Ciceri15, Maria Teresa Lupo-Stanghellini16, Loic Fouillard17, Irene García-Cadenas18, Mariacristina Menconi19, Igor Wolfgang Blau20, Luca Nassi21, Simone Cesaro4, Jan Styczynski22. 1. Division of Infectious Diseases, University of Genoa (DISSAL) and IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi, 10, Genova 16132, Italy. Electronic address: m.mikulska@unige.it. 2. Department Medical Statistics & Bioinformatics, EBMT Data Office, Leiden, the Netherlands. 3. Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genova, Italy. 4. Paediatric Haematology Oncology, Department of Mother and Child, Azienda Ospedaliera Universitaria Integrata, Verona, Italy. 5. Dipartimento Oncologia Ematologia, Terapia Intensiva Ematologica, Ospedale Civile, Pescara, Italy. 6. Department of Hematology, Hospital de la Princesa, Madrid, Spain. 7. Department of Hematology, Hospital 12 de Octubre, Madrid, Spain. 8. Department of Medicine, Division of Hematology and Clinical Immunology, University of Perugia, Perugia, Italy. 9. Pediatric Oncology Hematology, Santa Maria della Misericordia Hospital, Perugia, Italy. 10. Department for Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Stockholm, Sweden. 11. University Hospital Department of Haematology and Transplantology, Medical University of Gdansk, Gdansk, Poland. 12. Department of Hematology, Transplantation and Internal Medicine, University Clinical Center of the Medical University of Warsaw, Warsaw, Poland; Department of Hematology, Transplantation and Internal Medicine, Medical University of Warsaw, Warsaw, Poland. 13. Department of Hematology, Transplantation and Internal Medicine, Medical University of Warsaw, Warsaw, Poland. 14. Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genova, Italy. 15. Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy; School of Medicine, Vita-Salute San Raffaele University, Milano, Italy. 16. Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy. 17. Grand Hôpital de l`Est Francilien (GHEF), Meaux, France. 18. Hematology Department, Hospital de la Santa Creu i Sant Pau, Sant Pau and Jose Carreras Leukemia Research Institutes, Autonomous University of Barcelona, Barcelona, Spain. 19. Unità Operativa Oncoematologia Pediatrica, Azienda Ospedaliera Universitaria Pisa, Pisa, Italy. 20. Campus Virchow Klinikum CVK, Berlin, Germany. 21. Division of Hematology, Department of Translational Medicine, Universita' del Piemonte Orientale and Azienda Ospedaliero-Universitaria Maggiore della Carita, Novara, Italy. 22. Department of Pediatric Hematology and Oncology, University Hospital, Collegium Medicum UMK Torun, Bydgoszcz, Poland.
Abstract
OBJECTIVES: Limited data is available on HCV directly acting agents (DAAs) in haematopoietic stem cell transplant (HSCT) recipients. This study aimed at reporting the characteristics, treatment practices and treatment efficacy in HSCT recipients with chronic HCV. METHODS: Prospective observational study from EBMT Infectious Diseases Working Party (IDWP). Patients with chronic HCV infection were included. RESULTS: Between 12/2015 and 07/2018, 45 patients were included: male in 53%; median age 49 years (range, 8-75); acute leukaemia in 48.9%, lymphoma in 17.7%, non-malignant disorders in 22.3%; allogeneic HSCT in 84%; 77.8% no immunosuppressive treatment. Genotypes 1, 2, 3 and 4 were detected in 54.5%, 20.5%, 13.6% and 11.4%, respectively; advanced fibrosis in 40%, including cirrhosis in 11.4%. Overall, 37 (82.2%) patients received DAAs, at a median of 8.4 years after HSCT (16.2% within 6 months from HSCT). Sofosbuvir-based treatment was given to 62.2%. Thirty-five patients completed planned treatment course, with sustained virological response (SVR) of 89.1%, and 94.3% (33/35) in those who completed the treatment. Side effects possibly related to DAAs were reported in 5 (14%) and did not require treatment discontinuation. CONCLUSIONS: DAAs treatment was effective, safe and feasible in this cohort of mainly allogeneic HSCT recipients with mild/moderate liver damage.
OBJECTIVES: Limited data is available on HCV directly acting agents (DAAs) in haematopoietic stem cell transplant (HSCT) recipients. This study aimed at reporting the characteristics, treatment practices and treatment efficacy in HSCT recipients with chronic HCV. METHODS: Prospective observational study from EBMT Infectious Diseases Working Party (IDWP). Patients with chronic HCV infection were included. RESULTS: Between 12/2015 and 07/2018, 45 patients were included: male in 53%; median age 49 years (range, 8-75); acute leukaemia in 48.9%, lymphoma in 17.7%, non-malignant disorders in 22.3%; allogeneic HSCT in 84%; 77.8% no immunosuppressive treatment. Genotypes 1, 2, 3 and 4 were detected in 54.5%, 20.5%, 13.6% and 11.4%, respectively; advanced fibrosis in 40%, including cirrhosis in 11.4%. Overall, 37 (82.2%) patients received DAAs, at a median of 8.4 years after HSCT (16.2% within 6 months from HSCT). Sofosbuvir-based treatment was given to 62.2%. Thirty-five patients completed planned treatment course, with sustained virological response (SVR) of 89.1%, and 94.3% (33/35) in those who completed the treatment. Side effects possibly related to DAAs were reported in 5 (14%) and did not require treatment discontinuation. CONCLUSIONS: DAAs treatment was effective, safe and feasible in this cohort of mainly allogeneic HSCT recipients with mild/moderate liver damage.