Randomised study of steroid free immunosuppression with basiliximab induction vs standard triple drug immunosuppression in adult live donor liver transplantation (LDLT). CTRI/2017/08/009508

Introduction: Although there is data regarding steroid free immunosuppression following deceased donor liver transplantation, robust evidence is lacking in LDLT. Our aim was to evaluate the efficacy of steroid free immunosuppression with basiliximab induction following LDLT. Methodology: Out of 95 LDLT performed in 1 year at Amrita Institute of Medical Sciences, South India, after excluding 11 patients (Pre op renal dysfunction-3, APOLT-2, Multiorgan transplant-1, ABO incompatable- 2, Retransplant-1, massive bleed-2), 84 patients were randomized either to SF-arm (Basiliximab induction+ Tacrolimus and Azothioprine, n=42) or S-Arm (Steroid + Tacrolimus + Azothioprine, n=42). Primary objective was to compare graft rejection within six months, graft survival and metabolic complications. Results: Between SF-arm and S-arm, age(47.6 Vs 47.5 yrs), MELD score(24.6 Vs 23.19), duration of surgery(8.25 Vs 8.6 hrs), blood loss(2.2 Vs 2.7 litres), cold ischemia(76 Vs 78 mins) or GRWR(0.98 vs 0.96) were not statistically different. On a median follow up of 9.7 months, incidence of biopsy proven graft rejection(16.7% Vs 21.4 %, p-0.57), time to first rejection (99 vs 83 days, p-0.19), patient and graft survival(516 Vs 485days, p- 0.5) were not different between two groups. However the incidence of new onset diabetes after transplantation (NODAT) was significantly higher in S-arm at 3 months (68.2% Vs 21.7%, p-0.002) and at 6 months(54.5% Vs 13%, p-0.003). Likewise incidence of new onset hypertension(38.9% Vs 15%, p-0.018), hyper-triglyceridemia(27.8% Vs 7.5%, p-0.019) at six months were significantly higher in S-arm. Interestingly there was a higher incidence of hepatic artery thrombosis in the S-arm(9.5% vs 0 %, p-0.04). There were no difference in readmission rates, hospital stay, infectious complications and biliary complications. Conclusion: Steroid free immunosupression with basiliximab induction is as effective as the standard steroid based triple drug regimen with significantly lower metabolic complications.