title: Impact of immunosuppression without steroids on rejection and hepatitis C virus evolution after liver transplantation: results of a prospective randomized study.
abstract: The purpose of this study was to evaluate the influence of a steroid-free immunosuppression on hepatitis C virus (HCV) recurrence. A total of 198 liver transplantation (LT) patients were randomized to receive immunosuppression with basiliximab and cyclosporine, either with prednisone (steroid [St] group) or without prednisone (no steroids [NoSt] group). The group of 89 HCV-infected patients was followed up with protocol biopsies for 2 years after LT. This group of HCV patients are the patients evaluated in the present study. The rejection rate was 19% (St: 21% versus NoSt: 17%; P = 0.67). Patients in the St group had a slightly higher rate of bacterial infections (59% versus 38%; P = 0.05). Almost all patients had histological HCV-recurrence (St: 39/40 (97%) versus NoSt: 40/41 (97%); P = 1). The percentage of accumulated biopsies with grade 4 portal inflammation at 6 months, 1 year, and 2 years were, 23%, 49%, and 49% in the NoSt group, compared to 33%, 55%, and 69% in the St group, respectively (P = 0.04 at 2 years). The percentage of accumulated biopsies with grade 3 or 4 fibrosis at 6 months, 1 year, and 2 years were 0%, 8%, and 22% in the NoSt group, compared to 8%, 19%, and 31% in the St group, respectively. Immunosuppression without steroids in HCV patients is safe, reduces bacterial infections and metabolic complications, and improves histological short-term evolution of HCV recurrence.
authors.affiliation: Department of Surgery, Liver Transplant Unit, Hospital Universitari de Bellvitge, Institut d'Investigació Biomèdica de Bellvitge, Barcelona, Spain. 31513llg@comb.es
authors.forename: Laura
authors.initials: L
authors.lastname: Lladó
authors.forename: Joan
authors.initials: J
authors.lastname: Fabregat
authors.forename: Jose
authors.initials: J
authors.lastname: Castellote
authors.forename: Emilio
authors.initials: E
authors.lastname: Ramos
authors.forename: Xavier
authors.initials: X
authors.lastname: Xiol
authors.forename: Jaume
authors.initials: J
authors.lastname: Torras
authors.forename: Teresa
authors.initials: T
authors.lastname: Serrano
authors.forename: Carme
authors.initials: C
authors.lastname: Baliellas
authors.forename: Joan
authors.initials: J
authors.lastname: Figueras
authors.forename: Agustin
authors.initials: A
authors.lastname: Garcia-Gil
authors.forename: Antoni
authors.initials: A
authors.lastname: Rafecas
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000077552:Basiliximab; D016572:Cyclosporine / Q000009:adverse effects / Q000627:therapeutic use*; D019143:Evolution, Molecular; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006084:Graft Rejection / Q000473:pathology / Q000517:prevention & control* / Q000821:virology; D016174:Hepacivirus / Q000187:drug effects / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications / Q000517:prevention & control*; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods*; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008103:Liver Cirrhosis / Q000209:etiology / Q000601:surgery / Q000821:virology; D016031:Liver Transplantation; D008297:Male; D008775:Methylprednisolone / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D011993:Recombinant Fusion Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention
chemical_list: D000911:Antibodies, Monoclonal; D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D011993:Recombinant Fusion Proteins; D016572:Cyclosporine; D000077552:Basiliximab; D008775:Methylprednisolone