Steroid elimination 24 hours after liver transplantation using daclizumab,tacrolimus, and mycophenolate mofetil

Background. Corticosteroids have long been a cornerstone of orthotopic live r transplant (OLTx) immunosuppression. Newer, more potent, agents have succ essfully allowed for more rapid tapering and discontinuation of corticoster oids in OLTx recipients. We hypothesize that corticosteroids can be safely avoided after the first postoperative day (POD) using these newer agents. Methods. Thirty adult OLTx recipients were prospectively enrolled in a rand omized open-label, institutional review board-approved protocol. Fifteen pa tients (group A) received our standard regimen of tacrolimus, mycophenolate mofetil, and corticosteroids, and 15 patients (group B) received daclizuma b, 2 mg/kg on POD 0 and 14, with tacrolimus, mycophenolate mofetil, and cor ticosteroids on POD 0 and 1 and then discontinuation. In both groups, mycop henolate mofetil was tapered off between 3 and 4 months after OLTx. Bone mi neral densitometry was performed at 1, 3, and 6 months after OLTx. Quantita tive hepatitis C virus (HCV) polymerase chain reaction was obtained at days 0, 7, 14, 21, and 28. Retransplant recipients, patients with autoimmune he patitis, or status 1 or 2A patients were excluded. Results. Patient and graft survival rates were 93% (group A) and 100% (grou p B) with mean follow-up of 18 months. Patients in group B had more rejecti on diagnosed (25%) compared with group A (6.7%). Yet, the incidence of biop sy-proven acute rejection requiring steroid therapy was 6.7% in both groups . Hispanic race was common in groups A and B (87% and 74%). A total of six biopsies were performed in group B, with three patients having mild rejecti on responding to an increase in tacrolimus without the need for corticoster oids. One patient in group B was switched to cyclosporine for severe neurot oxicity and remains on monotherapy with normal graft function. No patient i n either group developed a requirement for additional antihypertensive medi cation. Likewise, there were no patients with new-onset diabetes. The bone mineral densitometry was higher in group B at every time point but did not reach statistical significance. Serum cholesterol level was significantly ( P=0.03) lower in group B at 6 months after OLTx. Serum triglycerides were a lso lower, but the difference was not significant. Quantitative polymerase chain reaction for HCV-positive patients (group A, n=7; group B, n=8) frequ ently increased after OLTx. There was no correlative decrease associated wi th daclizumab. At present, two patients in group A have documented HCV recu rrence. Conclusion. Corticosteroids can be safely avoided after POD 1 with the curr ent regimen. With early follow-up, there is no difference in hypertension o r diabetes or bone density. Lipid panels tended to be lower in patients who were not on corticosteroids. Longer term follow-up will be needed to demon strate the potential advantage of corticosteroid avoidance in regard to hyp ertension, diabetes, and possibly HCV recurrence.