Efficacy, safety and feasibility of treatment of chronic HCV infection with directly acting agents in hematopoietic stem cell transplant recipients – Study of infectious diseases working party of EBMT - 05/01/22

Doi : 10.1016/j.jinf.2021.10.024

Malgorzata Mikulska ^a,^⁎ , Nina Knelange ^b, Laura Ambra Nicolini ^c, Gloria Tridello ^d, Stella Santarone ^e, Paolo Di Bartolomeo ^e, Rafael de la Camara ^f, Clara Cuéllar ^g, Andrea Velardi ^h, Katia Perruccio ⁱ, Per Ljungman ^j, Jan Zaucha ^k, Agnieszka Piekarska ^k, Grzegorz Basak ^l,^m, Ewa Karakulska-Prystupiuk ^m, Emanuele Angelucci ⁿ, Fabio Ciceri ^o,^p, Maria Teresa Lupo-Stanghellini ^o, Loic Fouillard ^q, Irene García-Cadenas ^r, Mariacristina Menconi ^s, Igor Wolfgang Blau ^t, Luca Nassi ^u, Simone Cesaro ^d,^{^{1
These authors contributed equally to this work.}}, Jan Styczynski ^v,^{^{1
These authors contributed equally to this work.}}
^a Division of Infectious Diseases, University of Genoa (DISSAL) and IRCCS Ospedale Policlinico San Martino, Largo Rosanna Benzi, 10, Genova 16132, Italy
^b Department Medical Statistics & Bioinformatics, EBMT Data Office, Leiden, the Netherlands
^c Division of Infectious Diseases, IRCCS Ospedale Policlinico San Martino, Genova, Italy
^d Paediatric Haematology Oncology, Department of Mother and Child, Azienda Ospedaliera Universitaria Integrata, Verona, Italy
^e Dipartimento Oncologia Ematologia, Terapia Intensiva Ematologica, Ospedale Civile, Pescara, Italy
^f Department of Hematology, Hospital de la Princesa, Madrid, Spain
^g Department of Hematology, Hospital 12 de Octubre, Madrid, Spain
^h Department of Medicine, Division of Hematology and Clinical Immunology, University of Perugia, Perugia, Italy
ⁱ Pediatric Oncology Hematology, Santa Maria della Misericordia Hospital, Perugia, Italy
^j Department for Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Stockholm, Sweden
^k University Hospital Department of Haematology and Transplantology, Medical University of Gdansk, Gdansk, Poland
^l Department of Hematology, Transplantation and Internal Medicine, University Clinical Center of the Medical University of Warsaw, Warsaw, Poland
^m Department of Hematology, Transplantation and Internal Medicine, Medical University of Warsaw, Warsaw, Poland
ⁿ Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genova, Italy
^o Hematology and Bone Marrow Transplantation Unit, IRCCS San Raffaele Scientific Institute, Milano, Italy
^p School of Medicine, Vita-Salute San Raffaele University, Milano, Italy
^q Grand Hôpital de l`Est Francilien (GHEF), Meaux, France
^r Hematology Department, Hospital de la Santa Creu i Sant Pau, Sant Pau and Jose Carreras Leukemia Research Institutes, Autonomous University of Barcelona, Barcelona, Spain
^s Unità Operativa Oncoematologia Pediatrica, Azienda Ospedaliera Universitaria Pisa, Pisa, Italy
^t Campus Virchow Klinikum CVK, Berlin, Germany
^u Division of Hematology, Department of Translational Medicine, Universita’ del Piemonte Orientale and Azienda Ospedaliero-Universitaria Maggiore della Carita, Novara, Italy
^v Department of Pediatric Hematology and Oncology, University Hospital, Collegium Medicum UMK Torun, Bydgoszcz, Poland

^⁎Corresponding author.

Highlights

•	The vast majority of HSCT recipients is eligible for HCV DAA-based treatment.
•	DAAs are safe and effective in HSCT recipients.
•	DAAs premature discontinuation was rare and not related to side effects.

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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.

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Keywords : HCV, HSCT, Treatment, DAAs, Transplant, sofosbuvir

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Vol 84 - N° 1

P. 71-79 - janvier 2022 Retour au numéro

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Efficacy, safety and feasibility of treatment of chronic HCV infection with directly acting agents in hematopoietic stem cell transplant recipients – Study of infectious diseases working party of EBMT - 05/01/22

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