• Jan P Lerut, Rafael S Pinheiro, Quirino Lai, Valentine Stouffs, Giuseppe Orlando, Juan Manuel Rico Juri, Olga Ciccarelli, Christine Sempoux, Francine M Roggen, Chantal De Reyck, Dominique Latinne, and Pierre Gianello.
• *Starzl Unit of Abdominal Transplantation †Department of Pathology ‡Department Immunology, and §Department of Experimental Surgery, University Hospitals Saint-Luc, Université catholique Louvain (UCL), Brussels, Belgium ¶Department of Liver Transplantation, University of Sao Paulo (USP), Sao Paulo, Brazil ‖Department of Surgery, Section of Transplantation, Wake Forest School of Medicine, Winston-Salem, NC **Hepatobiliary Unit, Imbanaco Medical center, Cali, Colombia.
• Ann. Surg. 2014 Nov 1; 260 (5): 886-91; discussion 891-2.

ObjectiveTo investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT).BackgroundThe lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT.MethodsBetween February 2000 and September 2004, 156 adults were enrolled in a prospective, randomized, double-blind, placebo-controlled minimization trial comparing tacrolimus placebo (TAC-PLAC) and TAC short-term steroid (TAC-STER) IS. All patients had a minimum clinical, biochemical, and histological follow-up of 5 years.ResultsFive-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were 78.1% and 82.1% (P=0.89) and 74.2% and 76.9% (P=0.90), respectively. Five-year biopsies were available in 112 (89.6%) of 125 survivors. Twelve patients refused a biopsy because of their excellent evolution; tissue material was insufficient in 1 patient; 11 had normal liver tests; and 2 patients had developed alcoholic and secondary biliary cirrhosis. Histology was normal in 44 (39.3%) patients; 35 (31.3%) had disease recurrence. The remaining biopsies showed nonspecific chronic hepatitis (14.3%), mild inflammatory infiltrates (10.7%), and steatosis (3.5%). All findings were equally distributed between both groups. In each group, 3 patients (4.8%) presented with acute cellular rejection after the first year and only 1 (0.9%) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis. Arterial hypertension, diabetes mellitus, renal insufficiency, hypercholesterolemia, gout, and obesity were equally low in both groups.ConclusionsExcellent long-term results can be obtained under minimal IS and absence of steroids. TAC-based monotherapy is feasible in most adult liver recipients until 5 years of follow-up.

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