Double-blind comparison of hepatitis C histological recurrence rate in HCV plus liver transplant recipients given basiliximab plus steroids or basiliximab plus placebo, in addition to cyclosporine and azathioprine

Background. Hepatitis C virus (HCV) recurrence in HCV+1 liver transplant recipients is almost inevitable and maybe promoted by immunosuppression. We compared the amount of liver damage with regard to usage of steroids and basiliximab. Methods. A total of 140 HCV+ adult liver transplant recipients were randomly allocated to basiliximab+steroids or basilisimab+placebo (plus cyclosporine and azathioprine). Primary endpoint: hepatitis C histological recurrence (liver damage as for Ishak grading score greater than or equal to 8 by biopsy at 12 months); secondary endpoints: treatment failure (death, graft loss, patient withdrawal), biopsy proven acute rejection (BPAR), treated acute rejection (tAR), allograft and patient survival rates at 12 months. Results. Any significant difference has been observed in the 12-month hepatitis C histological recurrence rate (41.2% basiliximab+steroids, 37.5% basiliximab+placebo, P=0.354). The treatment failure rate was significantly higher in basiliximab+steroids (28.8%) than in basiliximab +placebo (15.6%), P=0.03; the combination test for the evaluation of the joint hypothesis resulted in a borderline nonsignificant overall result (P=0.059). BPAR rate was significantly lower in the group treated with steroids (24.3% basiliximab+steroids, 39.4% basiliximab +placebo, P=0.04), while the tAR rate was similar (29.7% basiliximab+steroids and 37.9% basiliximab+placebo). Any significant differences in 1-year graft and patient survival rates have been observed (72.9% and 84.8% basiliximab+steroids; 81.5% and 89.0% basiliximab +placebo). Conclusions. Results suggest that steroid-free therapy is associated with a significantly lower treatment failure rate, although histological recurrence rate of hepatitis C is similar in the two groups. This benefit is not offset by an evident increase in graft rejection rate requiring treatment.