期刊
AMERICAN JOURNAL OF TRANSPLANTATION
卷 19, 期 5, 页码 1397-1409出版社
WILEY
DOI: 10.1111/ajt.15205
关键词
clinical research/practice; clinical trial; immunosuppression/immune modulation; immunosuppressive regimens - minimization/withdrawal; infection and infectious agents viral: hepatitis C; liver transplantation/hepatology; tolerance
资金
- National Institute of Allergy and Infectious Diseases [UM1AI109565, UM2AI117870]
The Immune Tolerance Network ITN030ST A-WISH assessed immunosuppression withdrawal in liver transplant recipients with hepatitis C or nonimmune nonviral liver disease. Of 275 recipients enrolled before transplantation, 95 were randomly assigned 4: 1 to withdrawal (n = 77) or maintenance (n = 18) 1-to 2-years posttransplant. Randomization eligibility criteria included stable immunosuppression monotherapy; adequate liver and kidney function; = Stage 2 Ishak fibrosis; and absence of rejection on biopsy. Immunosuppression withdrawal followed an 8-step reduction algorithm with = 8 weeks per level. Fifty-two of 77 subjects (67.5%) reduced to = 50% of baseline dose, and 10 of 77 (13.0%) discontinued all immunosuppression for = 1 year. Acute rejection and/or abnormal liver tests were treated with increased immunosuppression; 5 of 32 rejection episodes required a methylprednisolone bolus. The composite end point (death or graft loss; grade 4 secondary malignancy or opportunistic infection; Ishak stage = 3; or > 25% decrease in glomerular filtration rate within 24 months of randomization) occurred in 12 of 66 (18%) and 4 of 13 (31%) subjects in the withdrawal and maintenance groups. Early immunosuppression minimization is feasible in selected liver recipients, while complete withdrawal is successful in only a small proportion. The composite end point comparison was inconclusive for noninferiority of the withdrawal to the maintenance group.
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