A Randomized Multicenter Study Comparing a Tacrolimus-Based Protocol with and without Steroids in HCV-Positive Liver Allograft Recipients.
Neumann U, Samuel D, et al.Journal of transplantation, AD 894215, 2012.
Aims
To evaluate the impact of steroid-free immunosuppression on hepatitis C virus (HCV) recurrence in HCV-positive liver allograft recipients.
Interventions
Steroid treatment for 3 months versus no steroid treatment (steroid free). All patients received tacrolimus. Daclizumab induction was given to patients who were randomized to the steroid free arm.
Participants
138 HCV-positive liver transplant recipients.
Outcomes
The primary endpoint was the viral load of HCV measured by serum HCV-RNA at 12 months, the incidence of and time to hepatitis C recurrence. Other outcomes included the incidence of and time to first biopsy-proven acute rejection, patient and graft survival at 12 months, renal function and the incidence of adverse events.
Follow-up
12 months
CET Conclusions
This randomized multicenter trial of a steroid free versus a steroid immunosuppressive regimen after liver transplantation was interesting in that although the steroid free arm received daclizumab induction with tacrolimus, in contrast to the steroid arm which received tacrolimus with steroids for 3 months, there was little to choose in terms of the impact on HCV viral load which was the primary end point. Discontinuation of the steroid free regimen was necessary in over half the patients for a variety of reasons but as the authors themselves say, the results are inconclusive as a result of the lack of completion in the steroid free arm.
Data analysis
Modified intention-to-treat analysis
Trial registration
Not reported